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Effects of Calcium Supplementation on Women in the Curves for Women Program

Texas A&M University logo

Texas A&M University

Status

Completed

Conditions

Diet Modification

Treatments

Dietary Supplement: Curves Calcium
Dietary Supplement: Calcium Carbonate
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03878667
IRB2008-0643

Details and patient eligibility

About

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.

Full description

The Curves International fitness and weight loss program has become a very popular means of promoting health and fitness among women. The program involves a 30-minute circuit training program and a weight management program involving periods of moderate caloric restriction (1,200 to 1,600 calories per day) followed by short periods of higher caloric intake (2,600 calories per day). The program is designed to promote a gradual reduction in body fat while increasing strength and muscle mass/tone. Researchers in the Exercise & Sport Nutrition Lab at Texas A&M University have conducted an extensive study on the effectiveness and safety of the Curves fitness and diet program. Results of this initial study have shown that the program promotes weight loss, improves markers of health, and improves fitness. However, we feel that the program may be even more effective with some additional nutritional interventions. Calcium has been shown to slow bone loss and more recently has been found to help promote fat loss. If this is the case, supplementing the diet with calcium may promote greater benefits in women participating in the Curves fitness/diet program. The purpose of this study is to examine the effect 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.

Enrollment

240 patients

Sex

Female

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 4 patient groups, including a placebo group

No Diet
Placebo Comparator group
Description:
No diet or exercise or calcium intervention
Treatment:
Dietary Supplement: Curves Calcium
Dietary Supplement: Calcium Carbonate
Dietary Supplement: Placebo
High Calorie Diet
Experimental group
Description:
High calorie (2,600 calorie) diet and exercise and calcium
Treatment:
Dietary Supplement: Curves Calcium
Dietary Supplement: Calcium Carbonate
Dietary Supplement: Placebo
Low Carbohydrate/High Protein Diet
Experimental group
Description:
Low carbohydrate (63% protein, 7% carbohydrate, 30% fat) diet and exercise and calcium
Treatment:
Dietary Supplement: Curves Calcium
Dietary Supplement: Calcium Carbonate
Dietary Supplement: Placebo
High Carbohydrate/Low Protein
Experimental group
Description:
High carbohydrate (15% protein, 55% carbohydrate, 30% fat) diet and exercise and calcium
Treatment:
Dietary Supplement: Curves Calcium
Dietary Supplement: Calcium Carbonate
Dietary Supplement: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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