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New treatment option for Body Composition
Official title Lifestyle Intervention to Improve Muscle Function in Older Adults
ClinicalTrials.gov ID: NCT07597980
What this study is testing
- What it's testing
- The goal of this randomized controlled two-arm trial is to determine the effect of a diet and exercise intervention for 12 weeks on body composition, muscle function, and energy balance in 80 adults aged 50 years and over with obesity and insulin resistance. The main questions the trial aims to answer are: Will 12 weeks of a structured nutrition plan + exercise reduce fat mass, improve muscle function, and increase energy deficit compared to the usual diet + exercise.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age \> 50 years.
- Body mass index (BMI) ≥ 30 kg/m2.
- Homeostatic model assessment of insulin resistance ≥ 3.
- Mini-Mental State Examination (MMSE) \> 25.
- Geriatric Depression Scale-15 (GDS-15) \< 9.
You likely can't join if
- Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal...
- Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal...
- Fluctuation in body weight \> 3 kg in the preceding two months
- Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
See the full eligibility criteria
- Age \> 50 years.
- Body mass index (BMI) ≥ 30 kg/m2.
- Homeostatic model assessment of insulin resistance ≥ 3.
- Mini-Mental State Examination (MMSE) \> 25.
- Geriatric Depression Scale-15 (GDS-15) \< 9.
- Sedentary (less than 90 minutes/week of moderate to vigorous activity).
- Ability to provide written informed consent.
- Diagnosis of cancer (received within five years) or diabetes (type 1 and 2), or significant musculoskeletal, or cardiovascular, or hepatic, or renal, disease or dysfunction.
- Clinically significant gastrointestinal malabsorption syndromes such as chronic diarrhea, celiac disease, or clinically significant abnormal laboratory markers.
- Fluctuation in body weight \> 3 kg in the preceding two months
- Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods.
The study team makes the final eligibility decision.
Where it's taking place
- Baton Rouge, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baton Rouge, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.