Curves 30/30 Study

NCT ID: NCT04344821

Last Updated: 2020-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-18

Study Completion Date

2012-05-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 Laboratory (ESNL) 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 and diet program. The purpose of this study is to determine whether following a high carbohydrate/low fat diet or high protein/low fat diet for 30-days several times during six months of participating in the Curves fitness and diet program with or without dietary calcium supplementation promotes stepwise reductions in body weight, improvements in body composition, and/or improvements in markers of fitness and health.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Weight Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, placebo controlled, repeated measures intervention trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators
Double (Participant, Investigator)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

No diet or exercise intervention

Group Type PLACEBO_COMPARATOR

Curves Calcium

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Curves Calcium

Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium \[as calcium citrate malate and calcium citrate\], 400 IU 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)

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dextrose Placebo

No Diet plus Exercise

No diet, exercise only intervention

Group Type EXPERIMENTAL

Curves Calcium

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Curves Calcium

Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium \[as calcium citrate malate and calcium citrate\], 400 IU 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)

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dextrose Placebo

High Protein Diet plus Exercise

High protein diet and exercise intervention

Group Type EXPERIMENTAL

Curves Calcium

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Curves Calcium

Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium \[as calcium citrate malate and calcium citrate\], 400 IU 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)

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dextrose Placebo

High Carbohydrate Diet plus Exercise

High carbohydrate diet and exercise intervention

Group Type EXPERIMENTAL

Curves Calcium

Intervention Type DIETARY_SUPPLEMENT

Dietary Supplement: Curves Calcium

Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium \[as calcium citrate malate and calcium citrate\], 400 IU 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)

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dextrose Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Curves Calcium

Dietary Supplement: Curves Calcium

Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium \[as calcium citrate malate and calcium citrate\], 400 IU 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)

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dextrose Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participant is female;
* Participant is post-menopausal;
* Participant is between the ages of 18 and 45;
* Participant is sedentary, overweight (BMI \> 27) and post-menopausal;

Exclusion Criteria

* Participant has any metabolic disorders 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.e., 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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Curves International

INDUSTRY

Sponsor Role collaborator

Texas A&M University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Richard B. Kreider

Executive Director, Human Clinical Research Facility

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Exercise & Sport Nutrition Laboratory

College Station, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB2008-0480

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.