Nutritional Restriction and Activity Thermogenesis - Full Text View

Purpose

These studies will provide us with enormous insight regarding how obese patients adapt energetically during negative energy balance. We will gain fundamental information regarding the metabolic implications of combining food restriction with a walking program compatible to that advocated by statutory agencies. These studies will lead to improved understanding of the energetic adaptation that occurs during negative energy balance and how best to treat patients with obesity.

Condition	Intervention	Phase
Obesity	Behavioral: Exercise and behavior modification	Phase I

MedlinePlus related topics:

Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Single Group Assignment

Official Title:	Nutritional Restriction and Activity Thermogenesis

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Non Exercise Activity Thermogenesis [ Time Frame: Weeks 2 and 11, each period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Body weight [ Time Frame: Daily ] [ Designated as safety issue: No ]
Body Composition [ Time Frame: Weeks 2 and 11, each period ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	June 2003
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Participants will undergo 1000 kcal/day caloric restriction (relative to experimentally determined weight-maintenance caloric needs) for 8 weeks during one phase of study. Additional 11 week period consists of 8 weeks of caloric restriction with an additional daily walking program.

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Ninety sedentary subjects, aged 25-55, who live <10 miles from Rochester will be recruited. This age range has been selected to enable us to study individuals at the peak age-range of obesity and over-weight prevalence and to avoid issues of menopause. Subjects will not be eligible for consideration if they take two or more bouts of exercise/week or participate in sports for more than 2 hours/week. Subjects with predicted weight maintenance energy requirements of <2000 kcal/day will have been excluded at screening. This is because when we come to underfeeding by 1000 kcal/day, we want to avoid feeding any volunteer <1000 kcal/day, for safety & compliance reasons.

(A) LEAN: 30 (15F,15M) lean subjects; BMI <25 kg/m2. Each lean subject will be individually matched for height (+3cm) and age (+3 years) to an obese subject so as to establish comparable groupings for body size. Subjects will have been weight-stable for six months (B) OBESE: 30 (15F,15M) obese subjects; BMI 30-35 kg/m2. Subjects will have been weight-stable for six months (C) POST-OBESE: 30 (15F,15M) patients will have had a previous BMI >30 kg/m2 and a weight loss sufficient to achieve a BMI of <26 kg/m2 maintained for at least 2 months (with weight fluctuation during this period of <1 kg) (94). We will attempt to match these subjects to the obese subjects as described above.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065338

Locations


United States, Minnesota
	Mayo Clinic
	Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

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

Investigators


Principal Investigator:	James A Levine, M.D., Ph.D.	Mayo Clinic

More Information

Publications of Results:

Levine JA, Lanningham-Foster LM, McCrady SK, Krizan AC, Olson LR, Kane PH, Jensen MD, Clark MM. Interindividual variation in posture allocation: possible role in human obesity. Science. 2005 Jan 28;307(5709):584-6.

Responsible Party:	Mayo Clinic ( James A. Levine, M.D., Ph.D., Consultant )
Study ID Numbers:	R01-DK 063226-01
First Received:	July 21, 2003
Last Updated:	March 14, 2008
ClinicalTrials.gov Identifier:	NCT00065338
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Physical activity

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Obesity

Nutrition Disorders

Overweight

Overnutrition

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00065338