Clinical trial NCT01264406: The Comparison of Energy in Take and Body Weight EXERCISE
Official title: Examination of Mechanisms (E-MECHANIC) of Exercise-induced Weight Compensation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise
Energy
Body Weight
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population group will be 198 sedentary, overweight and obese(BMI levels \> 25 kg/m2 and \< 40 kg/m2) individuals. Based on previous studies, we expect to enroll 132 females and 66 males. Participants will be randomly assigned to an 8 kcal/kg/week, 20 kcal/kg/week, or control group. The exercise groups will be closely monitored during exercise sessions for six months in our exercise-training laboratory.

Brief summary: This study will compare the effect of two doses of exercise on energy intake and body weight. The comparison will be between three groups; two exercise groups and a control group. The exercise groups will not be provided with a dietary intervention and the study design also includes a non-exercise control group. E-Mechanic trial can make important contributions to understanding of the role of exercise dose in weight management. While it is accepted that regular exercise plays an important role in general health, the exact role of exercise in prevention of weight gain, weight loss and prevention of weight regain remains poorly understood despite exercise being widely prescribed for these purposes. The idea that current weight management exercise recommendations may produce increased energy intake (or other forms on compensation) resulting in disappointing weight loss is an important public health issue. The finding of this study could help shape future exercise and weight loss recommendations and treatment plans.

Detailed description: The purpose of the E-MECHANIC Trial is to test the effect of two doses of exercise on energy intake, body weight, body composition, activity levels, and metabolic rate. The exercise doses will reflect current recommendations for: 1) general health (8 KKW), and 2) weight loss (20 KKW). A non-exercise control group will also be recruited. The primary outcome variables are: 1) energy intake, and 2) the discrepancy between expected weight loss and observed weight loss. Energy intake will be measured using doubly labeled water and laboratory-based food intake tests. Secondary outcome variables include resting metabolic rate, activity levels (excluding structured exercise), and body composition. Following a comprehensive baseline assessment, participants will be randomly assigned to the 8 KKW, 20 KKW, or control group in a 1:1:1 ratio. Additional assessments will be conducted at week 4, with another comprehensive assessment at week 24. The week 4 assessment is important to determine if endpoints change in the short-term, but not long-term.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 - 65 years old, inclusive

  * Not exercising \> 20 minutes on \> 3 days/wk and taking \< 8000 steps/d over one week measured with step counters.
  * BMI \> 25 kg/m2 and \< 40 kg/m2

Exclusion Criteria:

* • Current consumption of more than 14 alcoholic drinks per week

  * Plan to move out of the study area within the next 6 months or plan to be out of the study area for more than 4 weeks in the next 6 months
  * Have another member of household participating in the study
  * Residence too far from Pennington
  * A past history and/or physical examination or laboratory findings of the following medical conditions:

Table 1. Exclusion Criteria

* Cardiovascular disease (CVD) or disorders Potential participants with a history of CVD
* Blood Pressure Potential participants who are on a stable dose of antihypertensive medication, with the exception of beta-blockers, and whose blood pressure is controlled will be eligible for enrollment.
* Diabetes Potential participants with a previous diagnosis of diabetes (Type 1 or 2) or a fasting plasma glucose \>125 mg/dl will be excluded from the study.
* Blood lipids Potential participants whose LDL-C 190 mg/dl or TG levels 300 mg/dl will be referred to their physician.
* Hematologic disorders Participants diagnosed with hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states, will not be allowed into the study.
* Recent blood donation or blood loss Blood donation or blood loss from surgery or trauma during the 6 weeks before the baseline evaluation
* Weight loss-20 or more kilograms in the past year Other exclusions.
* Hospitalization for mental illness within the past 5 years or currently undergoing treatment for severe mental illness. Plans to be out of the city more than 4 weeks over the next 6 months
* Other significant medical conditions Including but not limited to chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions. Musculoskeletal problems interfering with exercise.
* Autoimmune or collagen vascular diseases. Immunodeficiency diseases or a positive HIV test. Malignancies in the past 5 years, with the exception of non-melanoma skin cancer therapeutically controlled. Any other medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise

Primary outcomes:
measure: A Comparison of the Effects of Energy Balance With Three Groups. [Energy Intake, Adjusted DLW]
timeFrame: 6 months after screening
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: PBRC
name: Corby Martin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: PBRC Co-Principal Investigator
name: Timothy Church, MD; MPH; PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: PBRC Co-Investigator
name: Conrad Earnest, PhD
role: STUDY_CHAIR
affiliation: PBRC Co-Investigator
name: Catrine Tudor-Locke, PhD
role: STUDY_CHAIR
affiliation: PBRC Co-Investigator
name: William Johnson, PhD
role: STUDY_CHAIR
affiliation: PBRC Co-Investigator
name: Jennifer Rood, PhD
role: STUDY_CHAIR
References:
citation: Dorling JL, Hochsmann C, Fearnbach SN, Apolzan JW, Hsia DS, Johannsen NM, Church TS, Martin CK. Initial Weight Change and Long-Term Changes in Weight and Compensation during Supervised Exercise Training. Med Sci Sports Exerc. 2021 Aug 1;53(8):1675-1684. doi: 10.1249/MSS.0000000000002633.
citation: Martin CK, Johnson WD, Myers CA, Apolzan JW, Earnest CP, Thomas DM, Rood JC, Johannsen NM, Tudor-Locke C, Harris M, Hsia DS, Church TS. Effect of different doses of supervised exercise on food intake, metabolism, and non-exercise physical activity: The E-MECHANIC randomized controlled trial. Am J Clin Nutr. 2019 Sep 1;110(3):583-592. doi: 10.1093/ajcn/nqz054.
citation: Sarzynski MA, Ruiz-Ramie JJ, Barber JL, Slentz CA, Apolzan JW, McGarrah RW, Harris MN, Church TS, Borja MS, He Y, Oda MN, Martin CK, Kraus WE, Rohatgi A. Effects of Increasing Exercise Intensity and Dose on Multiple Measures of HDL (High-Density Lipoprotein) Function. Arterioscler Thromb Vasc Biol. 2018 Apr;38(4):943-952. doi: 10.1161/ATVBAHA.117.310307. Epub 2018 Feb 8.
citation: Myers CA, Johnson WD, Earnest CP, Rood JC, Tudor-Locke C, Johannsen NM, Cocreham S, Harris M, Church TS, Martin CK. Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial. Trials. 2014 Jun 7;15:212. doi: 10.1186/1745-6215-15-212.