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High Protein Diet + Resistance Training for Weight Loss in Adults Over 50

N/A
Waitlist Available
Led By Drew Sayer, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
Ambulatory with or without a walking device or use of a manual wheelchair for mobility.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 8, 16, and 52
Awards & highlights

Study Summary

This trial is studying the effect of a high protein diet and/or resistance training on body composition in people over 50.

Who is the study for?
This trial is for men and women over 50 with obesity, who can walk with or without support or use a manual wheelchair. Women must be post-menopausal. Participants should have a BMI between 30-50 kg/m2 if ambulatory, or 25-50 kg/m2 for wheelchair users, but weigh less than 350 lbs.Check my eligibility
What is being tested?
The study tests the effects of a high-protein diet and resistance training on body weight in older adults. It uses group-based weight loss guidance delivered online. Participants will either follow this diet plan or do resistance exercises, with some getting additional protein supplements or supervised training if needed.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information; however, high-protein diets may cause kidney strain and digestive changes while resistance training could lead to muscle soreness or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 25-50, and I use a wheelchair.
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I can move around with some help or by using a wheelchair.
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My BMI is between 30-50, and I weigh 350 lbs or less.
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I am a woman and have gone through menopause.
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I am 50 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 8, 16, and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 8, 16, and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1st Stage Intervention Preference
1st Stage Treatment Credibility
2nd Stage Intervention Preference
+3 more
Secondary outcome measures
Body Weight
Fat free mass
Fat mass
Other outcome measures
Change in glucose
Change in insulin
Changes in aerobic fitness
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Resistance TrainingExperimental Treatment1 Intervention
Enrollment in State of Slim (SOS) weight loss program with resistance training counseling sessions.
Group II: High Protein DietExperimental Treatment1 Intervention
Enrollment in State of Slim (SOS) weight loss program with a high protein diet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Protein Diet
2017
N/A
~200
Resistance Training
2019
Completed Phase 2
~1190

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,591 Previous Clinical Trials
2,281,576 Total Patients Enrolled
72 Trials studying Obesity
474,189 Patients Enrolled for Obesity
Drew Sayer, PhDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
4 Previous Clinical Trials
100,190 Total Patients Enrolled
4 Trials studying Obesity
100,190 Patients Enrolled for Obesity

Media Library

Obesity Research Study Groups: Resistance Training, High Protein Diet

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants who are partaking in this clinical trial?

"Affirmative. Reported on clinicaltrials.gov, this trial is now enrolling patients having been initially posted on April 12th 2021 and last revised February 18th 2022. Ninety subjects are expected to join the experiment at a single site."

Answered by AI

What aims is this investigation striving to fulfill?

"The primary outcome of this clinical trial, to be evaluated between Baseline and Weeks 8 and 16, is alteration in fat mass. Secondary aims include alterations in muscle health of hands/forearms (measured via dynamometer), changes in fat-free mass at weeks 8, 16, and 52., and modifications to body weight at the same timepoints.."

Answered by AI

Are researchers still enrolling participants in this investigation?

"Yes, the clinicaltrial.gov page indicates that this trial is seeking participants; its original posting was made on April 12th 2021 and it has been revised most recently on February 18th 2022."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Other
Texas
Alabama
How old are they?
65+
18 - 65
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
2

Why did patients apply to this trial?

Critical that I loose weight. I've been trying to lose weight for a really long time and it's been practically impossible to do it.
PatientReceived no prior treatments
I've tried different drugs over the years and exercise but nothing seems to work long term. I'm ready for long term weight loss. I just need some guidance.
PatientReceived 1 prior treatment
I have a family history of obesity and hypothyroidism. Dieting has limited impact on my weight. My child is an adult and I recently retired. I’m ready to work on a new life for myself.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does the screening take?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. University of Alabama at Birmingham: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Weight Loss in Adults Over 50 With Obesity
Drew Sayer 2021. "Weight Loss in Adults Over 50 With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04014296.
~9 spots leftby Oct 2024
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