A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Grab-and-Go meal plan
* Other: Jump-Start meal plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Grab-and-Go meal plan<br>The intervention of this arm is to use a Grab-and-Go meal plan. This meal plan provides Atkins shakes and bars for breakfast, lunch, and snacks for 2 weeks. For dinner the subject is given a freshly-prepared meal. Upon finishing the 2-week provided food phase, the subject will consume a self-prepared meal of similar nutrient composition at home for another 2 weeks. For the next four weeks while he/she is still enrolled in the study, he/she will have his/her options for food choices which are not controlled for the study. | Other: Grab-and-Go meal plan<br>* The Grab-and-Go meal plan will provide Atkins shakes and bars for breakfast, lunch, and snacks. For dinner, the participant will receive a freshly-prepared meal. There will be no difference in terms of calories or nutrient composition between Grab-and-Go meal plan versus Jump-Start meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.<br>|
| Active Comparator: Jump-Start meal plan<br>The intervention of this arm is to use a Jump Start meal plan. This meal plan provides Atkins frozen meals at breakfast, lunch and dinner for 2 weeks and these meals are supplemented with fresh salads and vegetables. Upon finishing the 2-week provided food phase, the subject will consume a self-prepared meal of similar nutrient composition at home for another 2 weeks. For the next four weeks while he/she is still enrolled in the study, he/she will have his/her options for food choices which are not controlled for the study. | Other: Jump-Start meal plan<br>* The Jump-Start plan will provide Atkins frozen meals at breakfast, lunch and dinner and these meals will be supplemented with fresh salads and vegetables. There will be no difference in terms of calories or nutrient composition between Grab-and-Go meal plan versus Jump-Start meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss Between Baseline and 4 Weeks After Completion 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. | Change of body weight over 4 weeks of dietary intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Stiffness Changes Between Baseline and 4 Weeks | Pulse wave velocity, a non-invasive indicator of arterial stiffness will be assessed at the baseline testing and 4 weeks after the start of the dietary intervention. | Arterial stiffness will be measured at baseline and 4 weeks | 
| Plasma Uric Acid Level Between Baseline and 4 Weeks. | A fasting blood sample will be collected at baseline, 4 weeks after the start of the dietary intervention to measure plasma uric acid level. | Plasma uric acid level will be measured at baseline and 4 weeks | 
| Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks | Food craving questionnaire (FCI-II-State) will be administrated at baseline visit and the end of 4-week after dietary change. Cravings are assessed from 0 (no cravings: Not at all) to 5 (high cravings: Extremely/Always) for each of the five subscales measures including high-fat foods, sweets, carbohydrates/starches, fast-food fats, and fruits/vegetables. In addition, the scores for each of the subscales were averaged to produce a total cravings measure (also assessed from 0-5). | Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gender, arterial stiffness, blood pressure, weight loss, uric acid