80 Participants NeededMy employer runs this trial

Diet + Exercise for Muscle Function

CJ
RR
Overseen ByReilly Roberts A Project Manager, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Pennington Biomedical Research Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special diet combined with regular exercise can help people over 50 with obesity and insulin resistance improve muscle function and lose body fat. Participants will either follow a structured nutrition plan and supervised exercise routine or maintain their usual diet and exercise habits for 12 weeks. The trial aims to determine if the structured plan leads to better muscle strength and weight loss. Individuals with a BMI of 30 or higher who exercise less than 90 minutes per week might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance health outcomes for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diet and exercise intervention is safe for adults with obesity and insulin resistance?

Research has shown that following a planned diet and exercising with guidance is generally safe for participants. Previous studies found that these programs can boost muscle strength and overall fitness without major safety concerns. However, some people reported minor issues. For example, in one study, participants experienced pain and dizziness during exercise, leading to adjustments in their routines. Such reactions are not uncommon and can usually be managed. Overall, the combination of a planned diet and supervised exercise is well-tolerated, with benefits outweighing the risks for most people.12345

Why are researchers excited about this trial?

Researchers are excited about the Diet + Exercise for Muscle Function trial because it explores the impact of a structured nutrition plan combined with supervised exercise on muscle function. Unlike typical diet and exercise routines, this approach provides a specific, guided nutrition plan tailored to enhance muscle performance and growth. By combining this with expert-led exercise sessions, the trial aims to discover whether a more personalized and structured approach can offer significant improvements over standard practices in muscle health and function.

What evidence suggests that this trial's treatments could be effective for improving muscle function in adults with obesity and insulin resistance?

Research has shown that following a planned diet and exercise routine can significantly enhance muscle strength, muscle size, and body shape. In this trial, participants will join one of two groups: one will receive a structured nutrition plan combined with supervised exercise, while the other will follow a typical diet with supervised exercise. Studies indicate that combining a specific eating plan with exercise can boost muscle quality and reduce body fat. One study found that regular exercise, along with dietary changes, can improve physical abilities, such as walking speed and balance. Evidence suggests that the program's duration is crucial, with at least three months needed to see noticeable improvements in muscle strength. When followed consistently, this approach has improved muscle function and energy levels more effectively than typical diet and exercise habits.15678

Who Is on the Research Team?

CJ

Candida J Rebello, PhD, RD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults over 50 who have obesity (BMI of 30 or higher), show signs of insulin resistance, are mostly sedentary, and do not have significant memory problems or depression. Participants must be able to give consent.

Inclusion Criteria

Body mass index (BMI) ≥ 30 kg/m2
Homeostatic model assessment of insulin resistance ≥ 3
Mini-Mental State Examination (MMSE) > 25
See 4 more

Exclusion Criteria

Condition that impedes testing of the study hypothesis or makes it unsafe to exercise or consume the study foods
I have had cancer in the past five years or have diabetes or major organ disease.
I do not have serious digestive problems like chronic diarrhea or celiac disease.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a structured nutrition plan and exercise under supervision for 12 weeks

12 weeks
3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Structured nutrition plan
  • Supervised Exercise

Trial Overview

The study compares a structured nutrition plan plus supervised exercise versus usual diet plus the same exercise routine over 12 weeks. All meals are provided, and participants exercise three times per week at the center.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Structured nutrition plan + exerciseExperimental Treatment2 Interventions
Group II: Typical or usual diet + exerciseActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials
314
Recruited
183,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Effect of structured physical activity and nutritional ... - PMC

CONCLUSION: Results suggest improved gait speed following physical activity program with no further improvement with added nutritional supplementation. Keywords ...

Effectiveness of Home-Based Exercise and Nutrition ... - PMC

This scoping review investigates the volume of evidence for home-based exercise and nutrition programs and their effect on muscle quality among senior adults.

Effectiveness of Home-Based Exercise and Nutrition ...

This scoping review investigates the volume of evidence for home-based exercise and nutrition programs and their effect on muscle quality among senior adults.

Comparative Effectiveness of Exercise and Protein-Based ...

High-certainty evidence supports RBT + Nu as the most effective intervention for improving muscle strength, muscle mass, and physical function in individuals ...

(PDF) A Structured Diet and Exercise Program Promotes ...

During the 24-week maintenance phase, participants in the SDE group maintained greater moderate and vigorous physical activity levels, weight loss, fat loss, ...

Efficacy of a 12-week supervised home-based exercise ...

Primary outcome was the change in SMI at 12 weeks. Secondary outcomes included changes in psoas muscle index (PMI), Liver Frailty Index (LFI), aerobic fitness ( ...

Diet + Exercise for Muscle Function · Info for Participants

The hypothesis is that 12 weeks of a structured nutrition plan + exercise will reduce fat mass, improve muscle function, and produce greater energy deficit than ...

The impact of nutritional intervention and resistance training ...

A growing body of evidence confirms that nutritional supplementation strategies combined with resistance training can enhance muscle strength ...