Obesity, Overweight
Conditions
Keywords
Calcium Carbonate, Vitamin D, Body weight, Body fat, Metabolic parameters, Energy restriction, Very-low calcium consumers, Obesity, Overweight
Brief summary
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.
Detailed description
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.
Interventions
DRUGCalcium Carbonate
tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
BEHAVIORALEnergy restriction
A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female 18 to 25 years of age, generally healthy * Habitual calcium intake below 600mg/d * Overweight or obese (BMI between 24 and 35kg/m2, refer to the Chinese standard) * Stable body weight (body weight change less than 1kg two months before screening) * Less than 3 times of 20min of physical exercise per week * Signed written informed consent
Exclusion criteria
* Coronary heart disease, hypertension, diabetes; hepatic insufficiency or renal insufficiency, hyper- or hypothyroidism, mal-absorption, cholesterol concentrations requiring pharmaceutical treatment * Pregnant or lactating woman * Use of calcium supplements, oral antidiabetic agents, antihyperlipidemics or any other medications affecting metabolism 30 days before randomization * Participating in another weight loss programs (i.e. taking oral pharmacotherapeutic agents and/or herbal preparations intended for the management of obesity; excessive physical activity; be on a diet) * On special diets (i.e. vegetarian) * Presently taking or have recently taken a prescription drug such as fluoroquinolone antibiotics, tetracycline, or levothyroxine (thyroid medication) * Participating in another clinical trial 6 months before randomization * Unlikely to be compliant (i.e. alcohol, drug abuse) * Refusal or inability to give informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | Baseline and 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat Percentage | Baseline and 12 weeks | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage. |
| Change in Visceral Fat Area | Baseline and 12 weeks | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area. |
| Change in Blood Pressure | Baseline and 12 weeks | 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. |
| Change in Lipid-lipoprotein Profile | Baseline and 12 weeks | — |
| Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Baseline and 12 weeks | BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine body fat mass, body lean mass, and visceral fat mass. |
| Change in Fasting Plasma Insulin | Baseline and 12 weeks | — |
| Change in Energy Intakes | Baseline and 12 weeks | — |
| Change in Waist, Abdominal and Hip Circumference | Baseline and 12 weeks | Waist, abdominal and hip circumference was measured using a plastic tape to the nearest 0.1 cm |
| Change in Fasting Plasma Glucose | Baseline and 12 weeks | — |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Control A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure. | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Control | Calcium+D | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 26 Participants | 53 Participants |
| Age Continuous | 20.4 years STANDARD_DEVIATION 0.8 | 20.3 years STANDARD_DEVIATION 1.4 | 20.3 years STANDARD_DEVIATION 1.1 |
| Region of Enrollment China | 27 participants | 26 participants | 53 participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 0 / 27 |
Outcome results
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.
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium+D | Change in Body Weight | -3.9 kg | Standard Deviation 1.7 |
| Control | Change in Body Weight | -3.5 kg | Standard Deviation 1.8 |
p-value: 0.44195% CI: [-0.7, 1.58]t-test, 2 sided
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.
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium+D | Change in Blood Pressure | Systolic Blood Pressure | -8.3 mm Hg | Standard Deviation 13.2 |
| Calcium+D | Change in Blood Pressure | Diastolic Blood Pressure | -6.0 mm Hg | Standard Deviation 9.8 |
| Control | Change in Blood Pressure | Systolic Blood Pressure | -12.1 mm Hg | Standard Deviation 13.7 |
| Control | Change in Blood Pressure | Diastolic Blood Pressure | -5.0 mm Hg | Standard Deviation 9.3 |
Comparison: Systolic Blood Pressurep-value: 0.40495% CI: [-12.9, 5.3]t-test, 2 sided
Comparison: Diastolic Blood Pressurep-value: 0.76895% CI: [-5.52, 7.41]t-test, 2 sided
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.
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium+D | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Body Fat Mass | -2.8 kg | Standard Error 1.3 |
| Calcium+D | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Body Lean Mass | -0.9 kg | Standard Error 0.8 |
| Calcium+D | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Visceral Fat Mass | -0.47 kg | Standard Error 0.21 |
| Control | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Body Fat Mass | -1.9 kg | Standard Error 1.3 |
| Control | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Body Lean Mass | -1.4 kg | Standard Error 0.9 |
| Control | Change in Body Fat Mass，Body Lean Mass and Visceral Fat Mass | Visceral Fat Mass | -0.29 kg | Standard Error 0.21 |
Comparison: Body Fat Massp-value: 0.03895% CI: [0.05, 1.7]t-test, 2 sided
Comparison: Body Lean Massp-value: 0.08295% CI: [-1.06, 0.07]t-test, 2 sided
Comparison: Visceral Fat Massp-value: 0.01895% CI: [0.03, 0.32]t-test, 2 sided
Secondary
Change in Energy Intakes
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium+D | Change in Energy Intakes | -400.4 kcal/d | Standard Deviation 252 |
| Control | Change in Energy Intakes | -301.9 kcal/d | Standard Deviation 310.1 |
p-value: 0.27595% CI: [-81.6, 278.7]t-test, 2 sided
Secondary
Change in Fasting Plasma Glucose
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium+D | Change in Fasting Plasma Glucose | 0.25 mmol/L | Standard Deviation 0.33 |
| Control | Change in Fasting Plasma Glucose | 0.37 mmol/L | Standard Deviation 0.37 |
p-value: 0.2695% CI: [-0.1, 0.35]t-test, 2 sided
Secondary
Change in Fasting Plasma Insulin
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium+D | Change in Fasting Plasma Insulin | -1.18 mIU/L | Standard Deviation 5.02 |
| Control | Change in Fasting Plasma Insulin | -0.31 mIU/L | Standard Deviation 5.16 |
p-value: 0.59895% CI: [-2.44, 4.17]t-test, 2 sided
Secondary
Change in Fat Percentage
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine fat percentage.
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Calcium+D | Change in Fat Percentage | -2.6 Percentage of body weight | Standard Deviation 1.6 |
| Control | Change in Fat Percentage | -1.5 Percentage of body weight | Standard Deviation 1.5 |
p-value: 0.03195% CI: [0.1, 2.09]t-test, 2 sided
Secondary
Change in Lipid-lipoprotein Profile
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium+D | Change in Lipid-lipoprotein Profile | LDL | 0.14 mmol/L | Standard Deviation 0.51 |
| Calcium+D | Change in Lipid-lipoprotein Profile | TC | -0.11 mmol/L | Standard Deviation 0.43 |
| Calcium+D | Change in Lipid-lipoprotein Profile | TG | 0.02 mmol/L | Standard Deviation 0.42 |
| Calcium+D | Change in Lipid-lipoprotein Profile | HDL | 0.12 mmol/L | Standard Deviation 0.53 |
| Control | Change in Lipid-lipoprotein Profile | HDL | -0.14 mmol/L | Standard Deviation 0.48 |
| Control | Change in Lipid-lipoprotein Profile | LDL | 0.12 mmol/L | Standard Deviation 0.4 |
| Control | Change in Lipid-lipoprotein Profile | TG | 0.10 mmol/L | Standard Deviation 0.55 |
| Control | Change in Lipid-lipoprotein Profile | TC | -0.19 mmol/L | Standard Deviation 0.45 |
Comparison: TCp-value: 0.56595% CI: [-0.36, 0.2]t-test, 2 sided
Comparison: TGp-value: 0.63695% CI: [-0.24, 0.39]t-test, 2 sided
Comparison: HDLp-value: 0.11295% CI: [-0.58, 0.06]t-test, 2 sided
Comparison: LDLp-value: 0.64795% CI: [-0.11, 0.05]t-test, 2 sided
Secondary
Change in Visceral Fat Area
BIA (bioelectric impedance analysis, ZEUS9.9, JAWON) was used to determine visceral fat area.
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Calcium+D | Change in Visceral Fat Area | -12.5 cm^2 | Standard Deviation 6.2 |
| Control | Change in Visceral Fat Area | -6.8 cm^2 | Standard Deviation 7.2 |
p-value: 0.01695% CI: [1.15, 10.29]t-test, 2 sided
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
Time frame: Baseline and 12 weeks
Population: Males were excluded from final analysis for statistical reasons.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcium+D | Change in Waist, Abdominal and Hip Circumference | Waist Circumference | -6.2 cm | Standard Deviation 5.7 |
| Calcium+D | Change in Waist, Abdominal and Hip Circumference | Abdominal Circumference | -4.6 cm | Standard Deviation 4.4 |
| Calcium+D | Change in Waist, Abdominal and Hip Circumference | Hip Circumference | -4.2 cm | Standard Deviation 2.9 |
| Control | Change in Waist, Abdominal and Hip Circumference | Abdominal Circumference | -5.8 cm | Standard Deviation 8.3 |
| Control | Change in Waist, Abdominal and Hip Circumference | Hip Circumference | -3.2 cm | Standard Deviation 2.5 |
| Control | Change in Waist, Abdominal and Hip Circumference | Waist Circumference | -5.1 cm | Standard Deviation 5 |
Comparison: Waist Circumferencep-value: 0.50895% CI: [-2.31, 4.58]t-test, 2 sided
Comparison: Abdominal Circumferencep-value: 0.5695% CI: [-5.42, 2.98]t-test, 2 sided
Comparison: Hip Circumferencep-value: 0.25595% CI: [-0.74, 2.7]t-test, 2 sided