Clinical trial NCT04131647: Promotion of Weight Management
Official title: Promotion of Successful Weight Management in Overweight and Obese Veterans
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight
Keywords: Exercise
Diet
Obesity
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Baltimore VA Medical Center
name: South Texas Veterans Health Care System
First posted: 2019-10-18
Enrollment: 175
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Weight management program
Primary purpose: TREATMENT

Brief summary: The identification of intermittent fasting as an alternative method to traditional weight maintenance protocols could have a significant impact on preventing body weight regain common after successful weight loss, and potentially lead to a reduction in pharmaceutical and clinical costs related to the care of overweight and obese adults.

Detailed description: The research will examine the impact of intermittent fasting to promote long term body weight maintenance following successful weight loss in overweight and obese Veterans. This research is especially relevant to the majority of Veterans who struggle with obesity and maintaining weight loss. Obesity increases the risk for storing excess calories in ectopic depots, including skeletal muscle. Intramuscular fat is related to altered substrate utilization (metabolic inflexibility) and defects in insulin sensitivity, ultimately leading to type 2 diabetes mellitus and cardiovascular disease. The objective of this proposal is to test in a randomized clinical trial the effectiveness of an intensive weight management program with and without intermittent fasting (IF) to combat weight regain and the obesity crisis in our Veterans. Further, this application proposes to examine the role of several enzymes involved in skeletal muscle fatty acid oxidation as a mechanism for efficacious long term weight management.

Eligibility criteria: Inclusion Criteria:

* Veteran
* 50-75 years of age
* BMI: 25-40 kg/m2
* Postmenopausal status for women

Exclusion Criteria:

* Uncontrolled diabetes (HbA1c \>10% or the current use of insulin)
* Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments
* Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and psychiatric disease
* Weight change within the past month of \>5 kg
* Self-reported alcohol or drug abuse
* Anti-coagulant medication for muscle biopsies only Impaired renal function (creatinine \> 1.5 mg/dl) History or evidence of serious liver disease (LFTs \> 2.5 x WNL)

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
Secondary outcomes:
measure: Change in Gait Speed
timeFrame: Baseline, after 12 weeks of weight loss+exercise, at 36-week weight maintenance, and 48-week follow-up
measure: Change in body fat
timeFrame: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
measure: Change in LPL
timeFrame: Baseline, after 12 weeks of weight loss+exercise, and at 36-week weight maintenance
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
city: San Antonio
country: United States
facility: South Texas Health Care System, San Antonio, TX
state: Texas
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Alice S. Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: