Overview

This trial is active, not recruiting.

Condition over eating
Treatment overfeeding
Sponsor Pennington Biomedical Research Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date May 2008
End date February 2012
Trial size 40 participants
Trial identifier NCT01672632, 5R01DK060412, PBRC 26040

Summary

It has been shown that large fat cells are associated with more risks for insulin resistance and more cardiovascular risk factors such as high cholesterol or triglycerides.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Experimental)
We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.
overfeeding
We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.

Primary Outcomes

Measure
Determine the effect of 8-weeks 40% high fat overfeeding in 40 healthy, young adults on adipose and skeletal muscle characteristics, ectopic fat accumulation, insulin sensitivity, and metabolic flexibility.
time frame: 10 months

Secondary Outcomes

Measure
Fat Deposition
time frame: 10 Months
Insulin Sensitivity
time frame: 10 months
Muscle Oxidative Capacity
time frame: 10 Months
Circadian Blood Pressure variability
time frame: 10 Months
Resting Endothelial function testing
time frame: 10 Months

Eligibility Criteria

Male or female participants from 18 years up to 40 years old.

Inclusion Criteria: - Your Body Mass Index (height to weight ratio) is 22.5 to 32.5 (inclusive). - You are 18-40 years of age. - You are willing to enroll in an 8 week overfeeding study causing a 5-8 % weight gain. - You are willing to eat all your meals from Pennington and only meals from Pennington for approximately 10 weeks total, even when you are full. Prior to overfeeding 2 Meals per day will be served at Pennington with lunch packed for at least 7 days. After that time participants will receive and eat all (overfeeding) meals at PBRC for 8 weeks. Post-overfeeding will consists of weight-maintenance diet for 1 week. All meals will be monitored at Pennington. - You are willing to maintain the same level of exercise after enrollment in the study throughout the length of the study. - You are willing to complete nutritional and activity questionnaires. Exclusion Criteria: - You weight > 300 lbs - You have a history of cardiovascular disease or diabetes. - You have a fasting blood glucose > 110 mg/dL. - You have an average screening blood pressure > 140/90. - You have liver disease. - You have thyroid disease. - Have Acid Reflux - Had cancer in the last 5 years (Some skin cancers OK) - Have HIV - Have had an Eating Disorders - You are pregnant or breastfeeding. - You have gained or lost more than 3kg in the last 3 months - You require chronic use of medications including diuretics, steroids and adrenergic-stimulating agents. - You or a member of your family has a history of blood clots (deep vein thrombosis or pulmonary embolism) - You have poor circulation, history of bypass operation in your legs, blood coagulation disorders, diagnosed peripheral arterial or vascular disease, cramping pain in your leg muscle during exercise or nerve damage to your legs - You have varicose veins (per discretion of MD or NP) - You have had previous GI surgery, obstructive disease of the GI tract, hyper motility disorder or a history of problems of impairment of the gag reflex. - You have emotional problems such as clinical depression or other diagnosed psychological conditions. - You are claustrophobic. - You have metal objects in your body such as implanted rods or surgical clips or magnetic objects that are incompatible with the MRI/MRS. - You smoke or use tobacco products

Additional Information

Official title Fat Cell Size and Overfeeding and Etopic Study
Principal investigator Eric Ravussin, PhD
Description This study will look at fat cell size and how it affects fat deposition, insulin resistance and muscle oxidative capacity. A comparison will be made with the differences between participants with larger versus smaller fat cells in insulin resistance and blood levels of lipids. The study will also determine if characteristics of fat cells and muscle can predict the development of weight gain-induced insulin resistance.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pennington Biomedical Research Center.