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Lifestyle Intervention for Insulin Resistance

N/A

Recruiting

Led By Candida J Rebello

Research Sponsored by Pennington Biomedical Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Study Summary

This trial will test if a diet & exercise program can reduce insulin resistance & apathy in older adults, with or without soybean in the diet.

Who is the study for?

This trial is for older adults with insulin resistance and apathy but no diabetes. They should have a BMI of 30-40, be relatively inactive, and show certain levels on mental health and insulin resistance tests. People can't join if they've had significant weight changes recently, have type 1 or unmanaged type 2 diabetes, are taking certain medications affecting metabolism or body weight, or have major gastrointestinal issues.Check my eligibility

What is being tested?

The study is testing whether a specific diet and exercise program can improve insulin sensitivity and reduce apathy in participants. It will compare the effects of two diets: one including soybean to moderate blood glucose response versus one without soy. All meals are provided for 12 weeks alongside supervised exercise routines.See study design

What are the potential side effects?

Potential side effects from the dietary intervention may include digestive discomfort due to dietary changes. Exercise might cause muscle soreness or fatigue especially if participants were previously not very active.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apathy

Insulin sensitivity

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Diet with soyExperimental Treatment1 Intervention

Participants receive a diet to moderate the blood glucose response that includes soy

Group II: Diet without soyActive Control1 Intervention

Participants receive a diet to moderate the blood glucose response that does not include soy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor

304 Previous Clinical Trials

181,396 Total Patients Enrolled

6 Trials studying Insulin Sensitivity

98 Patients Enrolled for Insulin Sensitivity

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,017,023 Total Patients Enrolled

2 Trials studying Insulin Sensitivity

199 Patients Enrolled for Insulin Sensitivity

Candida J RebelloPrincipal InvestigatorPennington Biomedical Research Center

Media Library

Diet without soy Clinical Trial Eligibility Overview. Trial Name: NCT05649176 — N/A

Insulin Sensitivity Research Study Groups: Diet without soy, Diet with soy

Insulin Sensitivity Clinical Trial 2023: Diet without soy Highlights & Side Effects. Trial Name: NCT05649176 — N/A

Diet without soy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05649176 — N/A

Frequently Asked Questions

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

How many participants are being accepted into this research project?

"Affirmative. According to the information stored on clinicaltrials.gov, this experiment is actively seeking enrollees and was first posted on March 1st 2023; last updated February 14th 2023. There are 40 spots open across a single medical hub."

Answered by AI

Are there any vacancies yet for participants in this experiment?

"According to clinicaltrials.gov, this investigation is actively recruiting participants and was first posted on the 3rd of January 2023 with its last update occurring on the 14th February 2023."

Answered by AI

Is geriatric participation welcome for this experiment?

"Qualified applicants for this specific trial must be between 50 and 75 years of age. There are 26 trials available to those below the age of majority, while 96 cater to individuals over 65."

Answered by AI

Do I fulfill the prerequisites to join this medical trial?

"This clinical trial requires enlistment of 40 individuals aged between 50 and 75 that have apathy. Additional conditions include a Body Mass Index (BMI) between 30 to 40 kg/m2, no evidence of diabetes (fasting blood sugar <126 mg/dL), Mini-Mental State Examination score higher than 25, Geriatric Depression Scale-15 lower than 6, Apathy Evaluation Score greater than 30, Homeostatic Model Assessment of Insulin Resistance equal or higher than 3, and participants engaging in less than 90 minutes per week of moderate to vigorous physical activity."

Answered by AI

Recent research and studies

The American Journal of Clinical NutritionJournal

A Low–glycemic Index Diet Combined with Exercise Reduces Insulin Resistance, Postprandial Hyperinsulinemia, and Glucose-dependent Insulinotropic Polypeptide Responses in Obese, Prediabetic Humans

Solomon, Thomas PJ, Jacob M Haus, Karen R Kelly, Marc D Cook, Julianne Filion, Michael Rocco, Sangeeta R Kashyap, Richard M Watanabe, Hope Barkoukis, and John P Kirwan. 2010. “A Low–glycemic Index Diet Combined with Exercise Reduces Insulin Resistance, Postprandial Hyperinsulinemia, and Glucose-dependent Insulinotropic Polypeptide Responses in Obese, Prediabetic Humans”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.3945/ajcn.2010.29771.

clinicaltrials.govStudy

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Candida Rebello 2023. "Lifestyle Intervention for Improving Insulin Resistance and Concern for Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05649176.