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

Not Applicable

Completed

Conditions: Metabolic Syndrome

Interventions: Other: "Grab-and-Go" meal plan
Other: "Jump-Start" meal plan

Registration Number: NCT02774668

Lead Sponsor: University of Missouri-Columbia

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
"Grab-and-Go" meal plan	"Grab-and-Go" meal plan	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.
"Jump-Start" meal plan	"Jump-Start" meal plan	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.

Primary Outcome Measures

Name	Time	Method
Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention	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.

Secondary Outcome Measures

Name	Time	Method
Arterial Stiffness Changes Between Baseline and 4 Weeks	Arterial stiffness will be measured at 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.
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	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).
Plasma Uric Acid Level Between Baseline and 4 Weeks.	Plasma uric acid level will be measured at 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.