Clinical trial NCT00065338: Nutritional Restriction and Activity Thermogenesis
Official title: Nutritional Restriction and Activity Thermogenesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Physical activity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2003-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Non Exercise Activity Thermogenesis
timeFrame: Weeks 2 and 11, each period
Secondary outcomes:
measure: Body weight
timeFrame: Daily
measure: Body Composition
timeFrame: Weeks 2 and 11, each period
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James A Levine, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1126/science.1106561.