A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention
研究概览
简要总结
The present study is designed to examine the effect of changes in body weight and related parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter proposed to be studied here is the impact of fructose restriction and weight loss on serum uric acid concentrations and arterial stiffness.
详细描述
It is well know that consumption of a calorically-restricted diet helps people lose weight. Such a diet with low carbohydrate lowers the serum uric acid concentration which is a factor associated with obesity and also represents a particular metabolic risk in women compared to men. The present weight loss study will determine whether women benefit more than men to short-term weight loss occurring during restriction of simple sugars.
Specifically, this study is designed to cause weight loss acutely through consumption of a diet that is restricted in calorie and simple sugars. Both men and women will be studied and their results compared to determine whether women benefit more with respect to arterial stiffness. Upon finishing the four-week diet intervention, body weight and blood lipids will be assessed two and four weeks later to compare the longer term effect on blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and premenopausal women
- •30-55 years of age
- •Sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day
- •Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study)
- •Overweight/obese subjects with BMI 27.0 - 40.0 kg/m2 and any one of the following characteristics of the metabolic syndrome:
- •A. Serum HDL cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women B. Blood pressure ≥130/85 mmHg C. Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) D. Waist circumference in men of >102 cm (40 in) and in women of >88 cm (35 in) E. Serum triglycerides (TG) ≥150 mg/dL (1.7 mmol/L).
排除标准
- •Abnormal thyroid function or known liver disease
- •Diabetes or fasting glucose ≥ 125 mg/dL
- •Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules)
- •Occasional or regular tobacco use
- •History of gout
- •Uncontrolled hypertension
- •Pregnant or peri-menopausal
- •Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy)
- •Alcohol intake: females > 70 g/wk, males >140 g/wk
- •Moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.
结局指标
主要结局
Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention
时间窗: Change of body weight over 4 weeks of dietary intervention
For statistical analysis, the body weight is measured at baseline and after 4 weeks after consumption of a calorie-restricted, low-carbohydrate diet.
次要结局
- Arterial Stiffness Changes Between Baseline and 4 Weeks(Arterial stiffness will be measured at baseline and 4 weeks)
- Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks(Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan)
- Plasma Uric Acid Level Between Baseline and 4 Weeks.(Plasma uric acid level will be measured at baseline and 4 weeks)
研究者
Elizabeth Jane Parks
Professor, Nutrition & Exercise Physiology-MED
University of Missouri-Columbia