Skip to main content
OpenTrials
Completed

NCT Number: NCT02774668

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"Grab-and-Go" meal plan

Other

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

Other

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.

Primary outcomes

  1. Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention

    Time frame: 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 outcomes

  1. Arterial Stiffness Changes Between Baseline and 4 Weeks

    Time frame: 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.

  2. Plasma Uric Acid Level Between Baseline and 4 Weeks.

    Time frame: 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.

  3. Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Robert C. Atkins Foundation

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2016
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.