Effects of Calcium Supplementation on Women in the Curves for Women Program
NCT ID: NCT03878667
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
240 participants
INTERVENTIONAL
2004-01-01
2005-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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No Diet
No diet or exercise or calcium intervention
Curves Calcium
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 Carbonate
Calcium (providing 950 mg/d as carbonate)
Placebo
Dextrose placebo
High Calorie Diet
High calorie (2,600 calorie) diet and exercise and calcium
Curves Calcium
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 Carbonate
Calcium (providing 950 mg/d as carbonate)
Placebo
Dextrose placebo
Low Carbohydrate/High Protein Diet
Low carbohydrate (63% protein, 7% carbohydrate, 30% fat) diet and exercise and calcium
Curves Calcium
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 Carbonate
Calcium (providing 950 mg/d as carbonate)
Placebo
Dextrose placebo
High Carbohydrate/Low Protein
High carbohydrate (15% protein, 55% carbohydrate, 30% fat) diet and exercise and calcium
Curves Calcium
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 Carbonate
Calcium (providing 950 mg/d as carbonate)
Placebo
Dextrose placebo
Interventions
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Curves Calcium
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 Carbonate
Calcium (providing 950 mg/d as carbonate)
Placebo
Dextrose placebo
Eligibility Criteria
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Inclusion Criteria
* Participant is post-menopausal;
* Participant is between the ages of 45 and 65;
* Participant is sedentary, overweight (BMI \> 27) and post-menopausal;
Exclusion Criteria
* 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;
45 Years
65 Years
FEMALE
Yes
Sponsors
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Texas A&M University
OTHER
Responsible Party
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Richard B. Kreider
Executive Director, Human Clinical Research Facility
Principal Investigators
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Richard B Kreider, PhD
Role: PRINCIPAL_INVESTIGATOR
Texas A&M University
Other Identifiers
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IRB2008-0643
Identifier Type: -
Identifier Source: org_study_id
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