Clinical trial NCT02774668: A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Official title: A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: gender
arterial stiffness
blood pressure
weight loss
uric acid
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Robert C. Atkins Foundation
First posted: 2016-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Weight Loss Between Baseline and 4 Weeks After Completion of Dietary Intervention
timeFrame: Change of body weight over 4 weeks of dietary intervention
Secondary outcomes:
measure: Arterial Stiffness Changes Between Baseline and 4 Weeks
timeFrame: Arterial stiffness will be measured at baseline and 4 weeks
measure: Plasma Uric Acid Level Between Baseline and 4 Weeks.
timeFrame: Plasma uric acid level will be measured at baseline and 4 weeks
measure: Change in Food Craving Questionnaire (FCI-II-State) at Baseline and 4 Weeks
timeFrame: Questionnaires about food cravings will be administrated at baseline visit and 4 weeks after the start of the meal plan
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Qiong Hu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.