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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774668
• Other study ID #: 2004733
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: March 2023
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Men and premenopausal women

2. 30-55 years of age

3. 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

4. Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study)

5. 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:

1. Abnormal thyroid function or known liver disease

2. Diabetes or fasting glucose = 125 mg/dL

3. Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules)

4. Occasional or regular tobacco use

5. History of gout

6. Uncontrolled hypertension

7. Pregnant or peri-menopausal

8. Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy)

9. Alcohol intake: females > 70 g/wk, males >140 g/wk

10. 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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Overweight
• Weight Loss

Intervention

Other:
• "Grab-and-Go" meal plan
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.
• "Jump-Start" meal plan
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.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Robert C. Atkins Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Syed-Abdul MM, Hu Q, Jacome-Sosa M, Padilla J, Manrique-Acevedo C, Heimowitz C, Parks EJ. Effect of carbohydrate restriction-induced weight loss on aortic pulse wave velocity in overweight men and women. Appl Physiol Nutr Metab. 2018 Dec;43(12):1247-1256. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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