NCT00999154

Diet-Induced-Obesity Resistant Phenotypes in Humans

Terminated Last updated 3 December 2019

What this trial tests

trial in Healthy Volunteers in 9 participants. Terminated before completion.

Timeline

19 September 2009

22 October 2012

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	9
Start date	19 September 2009
Estimated completion	22 October 2012
Sites	1 location across United States

Conditions studied

• Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 25 to 50, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Obesity is the result of many factors, including genetics and lifestyle, such as over-eating high-calorie foods and not being physically active. Obesity affects approximately one third of adults in the United States. Researchers often study individuals who are already overweight and obese, but another approach is to examine people who stay thin despite eating whatever they want and not exercising. Studying these thin individuals will enhance understanding of why some people become obese and others do not, which may lead to novel treatments for obesity.

Objective:

\- To study the metabolism, body composition, body temperature, physical activity, and blood chemistries of healthy lean adults before and after adding 1,000 extra Calories per day to their normal diet.

Eligibility:

\- Healthy adults, 30 to 50 years of age, who have never been overweight after adolescence, who are currently weight-stable, sedentary, and eating without restrictions.

Design:

\- The entire study will take about 9 weeks and will include the following outpatient and inpatient visits:

\<TAB\>- Outpatient screening visit and monitoring: Physical examination and blood test at screening; then, one week of physical activity monitoring (e.g., with a pedometer-like device called an accelerometer) and completing a food diary.

\<TAB\>- Baseline inpatient visit (5 days): Volunteers will eat a normal diet to maintain body weight. Energy expenditure, body composition, physical fitness, activity level, and eating behavior will be measured. Urine and blood samples will be taken. Volunteers may go home for the weekend or stay at the metabolic clinical research unit (MCRU).

\<TAB\>- Inpatient feeding week 1 (5 days): Volunteers will eat a normal diet plus milkshakes for added calories. All the same measurements during the baseline week visit will be repeated.

\<TAB\>- Outpatient feeding weeks 2 3: Volunteers will eat breakfast at the MCRU everyday for the next 2 weeks and take prepared meals home with them (volunteers may also stay at the MCRU for the 2 weeks if they prefer). Volunteers will drink a non-radioactive (heavy) water called doubly labeled water to measure energy expenditure in their normal living environment Daily urine samples will be collected.

\<TAB\>- Inpatient feeding week 4 (5 days): Volunteers will continue eating a normal diet plus milkshakes for added calories. This stay and measurement is identical to inpatient feeding week 1.

\- Volunteers will be contacted at 6 and 12 months to assess any changes in body weight, diet, and physical activity.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.