| Primary | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Micrograms per litres (mcg/L) | | At baseline and at 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
| | | Title | Denominators | Categories |
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| At Baseline | | | Title | Measurements |
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| - OG0000.4440± 0.11932
- OG0010.4410± 0.16213
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| | At 6 months | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | Analysis was performed using ANCOVA model with product group and strata as fixed effects, and the corresponding baseline value as covariate. | 0.1324 | The setting of the two-sided significance level of 0.025 was used for the 2 co-primary endpoints to ensure that the overall significance level for the primary endpoint was less than or equal to 0.05. | Mean Difference (Final Values) | -0.0423 | | | 2-Sided | 97.5 | -0.1057 | 0.0211 | | | Difference is test product minus reference product such that a negative difference favors the test product. | | |
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| Primary | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Ratio | | At baseline and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | mcg/L | | At baseline and at 3 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Ratio | | At baseline and at 3 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. CTX-1 urine levels were analysed using biochemical tests from the samples stored. Decreased urinary CTX-1 is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | mcg/L | | At baseline, at 3 and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | NTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. NTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-NTX-1 is associated with improved bone health. The unit of measurement is nanomole bone collagen equivalent (NM BCE). | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | NM BCE | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. P1NP serum was analysed using biochemical tests from the samples stored. Increased s-P1NP is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | mcg/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | BSAP is a bone formation surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. BSAP serum was analysed using biochemical tests from the samples stored. Increased s-BSAP is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | mcg/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | PTH is used to compare calcium concentration status which defines the healthy bones. Intact PTH is the biologically active form and is secreted when the calcium level is low. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. PTH serum was analysed using biochemical tests from the samples stored. Decreased s-PTH is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Picomole per liter (pmol/L) | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | Urinary calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. Urinary calcium was analysed using biochemical tests from the samples stored. Decreased urinary calcium is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Millimoles per moles (mmol/mol) | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Calcium at 3 Months and 6 Months | Serum calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum calcium was analysed using biochemical tests from the samples stored. Increased serum calcium is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | Serum phosphorus is a diagnostic marker for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum phosphorus was analysed using biochemical tests from the samples stored. Increased serum phosphorus is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | mmol/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | ALP is a diagnostic marker of which is used to assess bone mineral density for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum ALP was analysed using biochemical tests from the samples stored. Increased serum ALP is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | Serum vitamin-D3 is used to analyse the status of vitamin-D profile which is necessary for healthy bones. The marker used for analyzing serum vitamin-D3 was 25 OH D3. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-D3 was analysed using biochemical tests from the samples stored. Increased serum vitamin-D3 is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | nmol/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | Serum Se is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum Se was analysed using biochemical tests from the samples stored. Increased serum Se is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | Micromole per liter (mcmol/L) | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | Plasma Zn is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased plasma Zn is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | mcmol/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | Serum folic acid (folate) is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased serum folate is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | nmol/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | Plasma vitamin-B6 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma vitamin-B6 was analysed using biochemical tests from the samples stored. Increased plasma vitamin-B6 is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | nmol/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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| Secondary | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | Serum vitamin-B12 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-B12 was analysed using biochemical tests from the samples stored. Increased serum vitamin-B12 is associated with improved bone health. | The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized. | Posted | | Mean | Standard Deviation | pmol/L | | At baseline, at 3 months and 6 months | | | | ID | Title | Description |
|---|
| OG000 | Test Product | Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | | OG001 | Reference Product | Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. |
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