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临床试验/NCT04344821
NCT04344821已完成不适用

Effects of Repeated Short-Term Diets on Weight Loss in Women Participating in the Curves Fitness Program

Texas A&M University2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2009年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
57
试验地点
2
主要终点
Body Composition: Body Fat

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

盲法说明

Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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;

结局指标

主要结局

Body Composition: Body Fat

时间窗: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

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)

Body Composition: Fat Free Mass

时间窗: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

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)

Body Composition: Bone Mass

时间窗: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

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)

Body Composition: Fat Mass

时间窗: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

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)

Body Composition: Lean Mass

时间窗: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

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)

Body Composition: Body Weight

时间窗: Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months

Changes in body composition (body weight) 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)

次要结局

  • Energy Homeostasis: Resting Energy Expenditure (REE)(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Energy Homeostasis: Respiratory Exchange Ratio (RER)(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Muscular Strength: 1 Repetition Maximum (1 RM) Bench Press(Measured prior to supplementation (Pre), and after 3, and 6 months)
  • Muscular Strength: 1 Repetition Maximum (1 RM) Leg Press(Measured prior to supplementation (Pre), and after 3, and 6 months)
  • Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Bench Press Endurance Test(Measured prior to supplementation (Pre), and after 3, and 6 months)
  • Muscular Endurance: 80% of 1 Repetition Maximum (1 RM) Leg Press Endurance Test(Measured prior to supplementation (Pre), and after 3, and 6 months)
  • Cardiac Variable: Resting Electrocardiogram (ECG)(Measured prior to supplementation (Pre), and after 3, and 6 months)
  • Cardiac Variable: Graded Exercise Test (GXT)(Measured prior to supplementation (Pre), and after 3, and 6 months)
  • Hemodynamic Variable: Resting Heart Rate (RHR)(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Lipid Panel: Triglycerides(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Hemodynamic Variable: Resting Systolic Blood Pressure (SBP)(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Hemodynamic Variable: Resting Diastolic Blood Pressure (DBP)(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Anthropometric Measures: Waist Circumference(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Anthropometric Measures: Hip Circumference(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Anthropometric Measures: Waist to Hip Ratio(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Fasting Glucose(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Lipid Panel: Cholesterol(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Lipid Panel: HDL Cholesterol(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Lipid Panel: Cholesterol to HDL Ratio(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)
  • Lipid Panel: LDL Cholesterol(Measured prior to supplementation (Pre), and after 1, 2, 3, 4, 5 and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard B. Kreider

Executive Director, Human Clinical Research Facility

Texas A&M University

研究点 (2)

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