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Nutritional Restriction and Activity Thermogenesis
This study is ongoing, but not recruiting participants.
Study NCT00065338   Information provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First Received: July 21, 2003   Last Updated: March 14, 2008   History of Changes

July 21, 2003
March 14, 2008
June 2003
November 2007   (final data collection date for primary outcome measure)
Non Exercise Activity Thermogenesis [ Time Frame: Weeks 2 and 11, each period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00065338 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Nutritional Restriction and Activity Thermogenesis
Nutritional Restriction and Activity Thermogenesis

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.

 
Phase I
Interventional
Diagnostic, Randomized, Open Label, Single Group Assignment
Obesity
Behavioral: Exercise and behavior modification
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
90
 
November 2007   (final data collection date for primary outcome measure)

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.

Both
25 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065338
James A. Levine, M.D., Ph.D., Consultant, Mayo Clinic
R01-DK 063226-01
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 
Principal Investigator: James A Levine, M.D., Ph.D. Mayo Clinic
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP