Effects of Calcium Supplementation on Women in the Curves for Women Program
1 other identifier
interventional
240
0 countries
N/A
Brief Summary
The purpose of this study is to examine the effects of dietary calcium supplementation on weight loss, bone density, and markers of health and fitness in women participating in the Curves exercise and diet program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2004
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2005
CompletedFirst Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 18, 2019
CompletedMarch 19, 2019
March 1, 2019
2 years
March 14, 2019
March 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Body Composition: Body Fat
Changes in body composition (% body fat) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Fat Free Mass
Changes in body composition (fat free mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Bone Mass
Changes in body composition (bone mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Fat Mass
Changes in body composition (fat mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Lean Mass
Changes in body composition (lean mass) obtained via DXA and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Body Composition: Body Weight
Changes in body weight (lbs. body weight) obtained via digital scale and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean change from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Energy Homeostasis: Resting Energy Expenditure (REE)
Changes in REE obtained via metabolic cart and expressed in absolute (kcals/d) and relative terms (kcals/kg/d) and analyzed by General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Energy Homeostasis: Respiratory Exchange Ratio (RER)
Changes in RER as an indicator of carbohydrate and fat oxidation analyzed with related resting energy expenditure outcome measures via General Linear Model multivariate and univariate analyses with repeated measures and mean changes from baseline with 95% confidence intervals (CI's)
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
Secondary Outcomes (69)
Muscular Strength: 1 Repetition Maximum (1RM) Bench Press
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Strength: 1 Repetition Maximum (1RM) Leg Press
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Bench Press Endurance Test
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Muscular Endurance: 80% of 1 Repetition Maximum (1RM) Leg Press Endurance Test
Measured prior to supplementation (Pre), after 10 weeks and 14 weeks
Body Composition: Body Water
Measured prior to supplementation (Pre), after 2 weeks, 10 weeks, 11 weeks and 14 weeks
- +64 more secondary outcomes
Study Arms (4)
No Diet
PLACEBO COMPARATORNo diet or exercise or calcium intervention
High Calorie Diet
EXPERIMENTALHigh calorie (2,600 calorie) diet and exercise and calcium
Low Carbohydrate/High Protein Diet
EXPERIMENTALLow carbohydrate (63% protein, 7% carbohydrate, 30% fat) diet and exercise and calcium
High Carbohydrate/Low Protein
EXPERIMENTALHigh carbohydrate (15% protein, 55% carbohydrate, 30% fat) diet and exercise and calcium
Interventions
Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium \[as calcium citrate malate and calcium citrate\], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
Calcium (providing 950 mg/d as carbonate)
Dextrose placebo
Eligibility Criteria
You may qualify if:
- Participant is female;
- Participant is post-menopausal;
- Participant is between the ages of 45 and 65;
- Participant is sedentary, overweight (BMI \> 27) and post-menopausal;
You may not qualify if:
- Participant has any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, or thyroid disease;
- Participant has a history of hypertension, hepatorenal, musculoskeletal, autoimmune or neurological disease;
- Participant is taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications;
- Participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (i.g., creatine, HMB, etc.), anabolic/catabolic hormone levels (i.e., androstenedione, DHEA, etc.) or weight loss (i.e., ephedra, thermogenics, etc.) within three months prior to the start of the study;
- Participant is consistently taking 500 mg or more of a Calcium supplement per day;
- Participant is receiving Hormone Replacement Therapy (HRT);
- Participant is involved in a planned exercise program within 3 - 6 months prior to the start of the study;
- Participant has lost \> 20 lbs. within the last 3 - 6 months;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard B Kreider, PhD
Texas A&M University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Director, Human Clinical Research Facility
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 18, 2019
Study Start
January 1, 2004
Primary Completion
December 31, 2005
Study Completion
December 31, 2005
Last Updated
March 19, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share