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Nutritional Restriction and Activity Thermogenesis

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00065338
First received: July 21, 2003
Last updated: April 1, 2011
Last verified: April 2011
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Nutritional Restriction and Activity Thermogenesis

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

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 ]

Enrollment: 90
Study Start Date: June 2003
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Exercise and behavior modification
    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
Mayo Clinic
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:

Responsible Party: James A. Levine, M.D., Ph.D., Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00065338     History of Changes
Other Study ID Numbers: DK63226 (completed), R01DK063226
Study First Received: July 21, 2003
Last Updated: April 1, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
Physical activity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013