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| Name | Class |
|---|---|
| Coventry University | OTHER |
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INTRODUCTION: Global protein consumption has been increasing for decades due to changes in socio-economic demographics and consumer trends towards higher protein intake, which may be related to their health benefits in performance nutrition and appetite regulation. The additional intake of protein often occurs in the form of supplements. One of the main ingredients used in sports and weight loss supplements are animal-derived proteins such as whey, which are of high quality, containing all the essential amino acids required in human nutrition with a high absorption rate. However, whey protein has a high environmental footprint, and it may contribute to insulin resistance in susceptible groups (e.g. obese, T2DM, insulin resistant, or those with sarcopenic obesity).
Rice and potato protein isolates are high-quality plant proteins containing all essential amino acids comparably to whey protein. These plant-derived proteins may provide a more sustainable and accessible alternative to animal-derived proteins for appetite regulation and weight management.
Intervention study with three treatment groups in a randomised, single-blind, triple crossover design.
Study population: Healthy male participants will receive three different isocaloric and -volumetric protein shakes prepared using whey, rice and potato protein powders on different trial days with at least a one-week washout period apart.
Biological samples (blood and saliva samples) are collected at various time points during the visit. Blood samples are collected at baseline 10 min prior (T-10), then at 30 min (T30), 60 min (T60), 120 min (T120) and at 180 min (T180) after protein shake consumption. Saliva samples are collected at baseline (T-10), then at every 30 minutes following protein shake consumption (T30, T60, T90, T120, T150, T180). In addition, pertinent questionnaires Visual Analogue Scale [VAS] for the assessment of satiety and VAS for the assessment of protein shakes' perception will be collected at T-10, T30, T60, T90, T120, T150, T180 and at T0, respectively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whey protein | Active Comparator | Whey protein isolate (45.5g total protein content) |
|
| Potato protein | Active Comparator | Potato protein isolate (45.3g total protein content) |
|
| Rice protein | Active Comparator | Rice protein isolate (45.5g total protein content) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein isolate | Dietary Supplement | Instantized BiPRO® 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake. Other ingredients in the whey protein shake:
The total energy 233.47Kcal. Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T-10) | Marker: glucose (mmol/L) | Glucose measured 10 minutes prior to protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T30) | Marker: glucose (mmol/L) | Glucose measured 30 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T60) | Marker: glucose (mmol/L) | Glucose measured 60 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T120) | Marker: glucose (mmol/L) | Glucose measured 120 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucose levels (T180) | Marker: glucose (mmol/L) | Glucose measured 180 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T-10) | Marker: insulin (ng/mL) | Insulin measured 10 minutes prior to protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T30) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the perception of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® | Subjective analysis including: Visual Analogue Scale for Palatability (VAS-P). Scores range from 0 to 100 (the higher the score the lower the palatability) | VAS for Palatability collected immediately after protein shake consumption |
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Inclusion Criteria:
Exclusion Criteria:
Participants' eligibility is based on self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Gulrez Zariwala, PhD | University of Westminster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Westminster | London | Greater London | W1W 6UW | United Kingdom |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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single-blind, randomised, triple crossover
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|
| Potato protein isolate | Dietary Supplement | Solanic®100 48g (equiv. 45.3g of total protein) presented to participants in a form of a shake. Other ingredients in the potato protein shake:
The total energy 233.46Kcal Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study. |
|
| Rice protein isolate | Dietary Supplement | Oryzatein® Silk 90 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake. Other ingredients in the rice protein shake:
The total energy 233.43Kcal Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study. |
|
Marker: insulin (ng/mL) |
| Insulin measured 30 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T60) | Marker: insulin (ng/mL) | Insulin measured 60 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T120) | Marker: insulin (ng/mL) | Insulin measured 120 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on insulin levels (T180) | Marker: insulin (ng/mL) | Insulin measured 180 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T-10) | Markers: glucagon-like peptide 1 (pM) | Glucagon-like peptide 1 measured 10 minutes prior to protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T30) | Markers: glucagon-like peptide 1 (pM) | Glucagon-like peptide 1 measured 30 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T60) | Markers: glucagon-like peptide 1 (pM) | Glucagon-like peptide 1 measured 60 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T120) | Markers: glucagon-like peptide 1 (pM) | Glucagon-like peptide 1 measured 120 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on glucagon-like peptide 1 levels (T180) | Markers: glucagon-like peptide 1 (pM) | Glucagon-like peptide 1 measured 180 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T-10) | Markers: peptide tyrosine tyrosine (pg/mL) | Peptide tyrosine tyrosine measured 10 minutes prior to protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T30) | Markers: peptide tyrosine tyrosine (pg/mL) | Peptide tyrosine tyrosine measured 30 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T60) | Markers: peptide tyrosine tyrosine (pg/mL) | Peptide tyrosine tyrosine measured 60 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T120) | Markers: peptide tyrosine tyrosine (pg/mL) | Peptide tyrosine tyrosine measured 120 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on peptide tyrosine tyrosine levels (T180) | Markers: peptide tyrosine tyrosine (pg/mL) | Peptide tyrosine tyrosine measured 180 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T-10) | Markers: ghrelin (pg/mL) | Ghrelin (pg/mL) measured 10 minutes prior to protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T30) | Markers: ghrelin (pg/mL) | Ghrelin (pg/mL) measured 30 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T60) | Markers: ghrelin (pg/mL) | Ghrelin (pg/mL) measured 60 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T120) | Markers: ghrelin (pg/mL) | Ghrelin (pg/mL) measured 120 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on ghrelin levels (T180) | Markers: ghrelin (pg/mL) | Ghrelin (pg/mL) measured 180 minutes post protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T-10) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected immediately prior to protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T30) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected 30 minutes after protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T60) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected 60 minutes after protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T90) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected 90 minutes after protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T120) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected 120 minutes after protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T150) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected 150 minutes after protein shake consumption |
| To assess the acute effects of Solanic®100, Oryzatein® Silk 90 and Instantized BiPRO® on appetite (T180) | Subjective analysis including: Visual Analogue Scale for Appetite (VAS-A). Scores range from 0 to 100 (the higher the score the greater the level of appetite) | Visual Analogue Scale for Appetite (VAS-A) collected 180 minutes after protein shake consumption |