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The purpose of the study is to determine whether calcium plus vitamin D supplementation is conducive to weight and fat loss during energy restriction in very-low calcium consumers.
Due to the contradicting findings in the hypothesis of calcium supplementation on weight and fat loss, which might be explained by the difference in initial calcium intake, the present study is aimed to evaluate the effect of calcium plus vitamin D supplementation on accelerating weight and fat loss in overweight or obese subjects with very-low calcium consumption(<600mg/day).
The hypotheses to be tested are:
Calcium plus vitamin D supplementation is conducive to body weight and fat loss in overweight or obese young adults during energy restriction 12 weeks after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium+D | Experimental | Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
|
| Control | Placebo Comparator | A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Carbonate | Drug | tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass. | Baseline and 12 weeks |
| Change in Fat Percentage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donglian Cai, Master | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23297844 | Derived | Zhu W, Cai D, Wang Y, Lin N, Hu Q, Qi Y, Ma S, Amarasekara S. Calcium plus vitamin D3 supplementation facilitated fat loss in overweight and obese college students with very-low calcium consumption: a randomized controlled trial. Nutr J. 2013 Jan 8;12:8. doi: 10.1186/1475-2891-12-8. |
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The pre-screening FFQ excluded 34 volunteers for habitual calcium intake>600mg/day. During screening, 16 were excluded for BMI<24kg/m2, 3 reported for using calcium supplements, 14 were on a diet, 2 refused to take calcium supplements, 1 refused to being taken blood samples, and 6 failed to sign the informed consents for personal reasons.
Participant were recruited through informational flyers and advertisements posted on campus of colleges and vocational schools in Pudong and Yangpu Districts in Shanghai, China. From April 20th to September 20th, 2011, a total of 129 out of 187 volunteers who answered our recruitment advertisements were invited for a pre-screening interview.
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| ID | Title | Description |
|---|---|---|
| FG000 | Calcium+D | Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
| FG001 | Control | A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Calcium+D | Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Weight was obtained in light clothing to the nearest 0.1kg using a digital scale 8:00am and 10:00am after an overnight fast between. | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | kg | Baseline and 12 weeks |
|
12 weeks
Adverse event was assessed by questionnaires during biweekly interviews with dietitians throughout the program.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Calcium+D | Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
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The study sample was mostly women.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Donglian Cai | Changhai Hospital | 86 21 81873168 | nutrition1226@126.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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| Energy restriction | Behavioral | A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. |
|
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
| Baseline and 12 weeks |
| Change in Visceral Fat Area | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area. | Baseline and 12 weeks |
| Change in Waist, Abdominal and Hip Circumference | Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm | Baseline and 12 weeks |
| Change in Blood Pressure | Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer. | Baseline and 12 weeks |
| Change in Lipid-lipoprotein Profile | Baseline and 12 weeks |
| Change in Fasting Plasma Glucose | Baseline and 12 weeks |
| Change in Fasting Plasma Insulin | Baseline and 12 weeks |
| Change in Energy Intakes | Baseline and 12 weeks |
| Protocol Violation |
|
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass. | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Error | kg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Fat Percentage | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage. | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | Percentage of body weight | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Visceral Fat Area | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area. | Males were excluded from final analysis for statistical reasons. | Posted | Median | Standard Deviation | cm^2 | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Waist, Abdominal and Hip Circumference | Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | cm | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Blood Pressure | Systolic and diastolic blood pressures were measured in the left arm at heart level of subjects seated for a minimum of 5 minutes using mercurial sphygmomanometer. | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | mm Hg | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Lipid-lipoprotein Profile | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Fasting Plasma Glucose | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Fasting Plasma Insulin | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | mIU/L | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change in Energy Intakes | Males were excluded from final analysis for statistical reasons. | Posted | Mean | Standard Deviation | kcal/d | Baseline and 12 weeks |
|
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Control | A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. | 0 | 27 | 0 | 27 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| Visceral Fat Mass |
|
| 0.082 |
| Median Difference (Net) |
| -0.50 |
| Standard Error of the Mean |
| 0.28 |
| 2-Sided |
| 95 |
| -1.06 |
| 0.07 |
| No |
| Superiority or Other |
| Visceral Fat Mass | t-test, 2 sided | 0.018 | Median Difference (Net) | 0.18 | Standard Error of the Mean | 0.07 | 2-Sided | 95 | 0.03 | 0.32 | No | Superiority or Other |
| Hip Circumference |
|
| t-test, 2 sided |
| 0.560 |
| Mean Difference (Net) |
| -1.22 |
| Standard Error of the Mean |
| 2.07 |
| 2-Sided |
| 95 |
| -5.42 |
| 2.98 |
| No |
| Superiority or Other |
| Hip Circumference | t-test, 2 sided | 0.255 | Median Difference (Net) | 0.98 | Standard Error of the Mean | 0.85 | 2-Sided | 95 | -0.74 | 2.70 | No | Superiority or Other |
| t-test, 2 sided |
| 0.768 |
| Mean Difference (Net) |
| 0.94 |
| Standard Error of the Mean |
| 3.18 |
| 2-Sided |
| 95 |
| -5.52 |
| 7.41 |
| No |
| Superiority or Other |
| HDL |
|
| LDL |
|
| 0.636 |
| Median Difference (Net) |
| 0.07 |
| Standard Error of the Mean |
| 0.15 |
| 2-Sided |
| 95 |
| -0.24 |
| 0.39 |
| No |
| Superiority or Other |
| HDL | t-test, 2 sided | 0.112 | Median Difference (Net) | -0.26 | Standard Error of the Mean | 0.16 | 2-Sided | 95 | -0.58 | 0.06 | No | Superiority or Other |
| LDL | t-test, 2 sided | 0.647 | Median Difference (Net) | -0.02 | Standard Error of the Mean | 0.15 | 2-Sided | 95 | -0.11 | 0.05 | No | Superiority or Other |