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

NCT02774668 | Completed Results

• 1 other identifier: 2004733
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

gender; arterial stiffness; blood pressure; weight loss; uric acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Arterial Stiffness Changes Between Baseline and 4 Weeks

  Arterial stiffness will be measured at baseline and 4 weeks

• Plasma Uric Acid Level Between Baseline and 4 Weeks.

  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

  Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan

Study Arms (2)

"Grab-and-Go" meal plan

ACTIVE COMPARATOR

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

"Jump-Start" meal plan

ACTIVE COMPARATOR

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

Interventions

"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.

"Grab-and-Go" meal plan

"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.

"Jump-Start" meal plan

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and premenopausal women
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Robert C. Atkins Foundation: collaborator

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related 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. doi: 10.1139/apnm-2018-0113. Epub 2018 May 10.

  PMID: 29746789 RESULT

MeSH Terms

Conditions

Metabolic Syndrome; Coitus; Weight Loss

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Sexual Behavior; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations are as follows. The loss of weight with low-CHO diet is being assessed over a short period of time. The study has a small sample size and also, it is unknown if these effects would persist with a longer study duration.

Results Point of Contact

• Title: Elizabeth Parks, Professor of Nutrition and Exercise Physiology
• Organization: University of Missouri

parksej@missouri.edu

573-882-5864

Study Officials

• Qiong Hu, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Nutrition & Exercise Physiology-MED

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 4, 2025
• Results First Posted: March 30, 2023

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)