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Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Primary Purpose

Insulin Sensitivity, Apathy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet without soy
Diet with soy
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Sensitivity

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Body mass index (BMI) from 30 to 40 kg/m2 No evidence of diabetes (fasting blood sugar <126 mg/dL) Mini-Mental State Examination (MMSE) > 25 Geriatric Depression Scale-15 (GDS-15) < 6 Apathy Evaluation Scale - score > 30 Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3 Sedentary: < 90 minutes of moderate to vigorous physical activity/week. Exclusion Criteria: Prior history of type 2 diabetes. Participants who have type 1 diabetes Participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight. Participants who are on concomitant therapy with glucocorticoids. Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction. Participants that have had a fluctuation in body weight >5% in the preceding 2 months. Any other conditions that may impede testing of the study hypothesis.

Sites / Locations

  • Pennington Biomedical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diet without soy

Diet with soy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Insulin sensitivity
Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test
Apathy
Apathy will be evaluated using the Apathy Evaluation Scale

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
April 11, 2023
Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05649176
Brief Title
Lifestyle Intervention for Improving Insulin Resistance and Concern for Health
Official Title
Lifestyle Intervention for Improving Metabolic and Motivational Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. The main questions the study aims to answer are: Does the diet and exercise program improve insulin resistance and apathy? Does the addition of soybean to the diet enhance the effect? Participants will be given all meals for 12 weeks and will exercise under supervision. They will undergo a test of insulin sensitivity and complete questionnaires. Researchers will compare the groups given: A diet to moderate the blood glucose response that contains soybean; and A diet to moderate the blood glucose response that does not contain soybean.
Detailed Description
This randomized trial will examine the blood glucose moderating effect of a diet and exercise program in 40 older adults with obesity, insulin resistance, and apathy. The primary objective of this study is to examine the effect of a diet and exercise program on insulin sensitivity and apathy and determine if the addition of soybean to the diet enhances the effect. The primary outcomes of the study are insulin sensitivity measured using the hyperinsulinemic euglycemic clamp test and apathy evaluated using the Apathy Evaluation Scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Apathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled two-arm parallel trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
This is a feeding study. All participants will receive a diet designed to moderate the blood glucose response. The diets will be similar except that in the experimental group soybean flour (soy) will be incorporated into the foods
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diet without soy
Arm Type
Active Comparator
Arm Description
Participants receive a diet to moderate the blood glucose response that does not include soy
Arm Title
Diet with soy
Arm Type
Experimental
Arm Description
Participants receive a diet to moderate the blood glucose response that includes soy
Intervention Type
Other
Intervention Name(s)
Diet without soy
Other Intervention Name(s)
Low glycemic index and reduced energy density
Intervention Description
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the experimental diet but does not contain soy.
Intervention Type
Other
Intervention Name(s)
Diet with soy
Other Intervention Name(s)
Low glycemic index and reduced energy density
Intervention Description
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test
Time Frame
12 weeks
Title
Apathy
Description
Apathy will be evaluated using the Apathy Evaluation Scale
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) from 30 to 40 kg/m2 No evidence of diabetes (fasting blood sugar <126 mg/dL) Mini-Mental State Examination (MMSE) > 25 Geriatric Depression Scale-15 (GDS-15) < 6 Apathy Evaluation Scale - score > 30 Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3 Sedentary: < 90 minutes of moderate to vigorous physical activity/week. Exclusion Criteria: Prior history of type 2 diabetes. Participants who have type 1 diabetes Participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight. Participants who are on concomitant therapy with glucocorticoids. Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction. Participants that have had a fluctuation in body weight >5% in the preceding 2 months. Any other conditions that may impede testing of the study hypothesis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amber Dragg, PhD
Phone
12257633050
Email
Amber.Dragg@pbrc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Candida J Rebello, MD
Phone
12257633159
Email
Candida.Rebello@pbrc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candida J Rebello
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candida Rebello, Ph.D.
Phone
225-763-3159
Email
Candida.Rebello@pbrc.edu
First Name & Middle Initial & Last Name & Degree
Frank Greenway, M.D.
Phone
2257632576
Email
Frank.Greenway@pbrc.edu
First Name & Middle Initial & Last Name & Degree
Frank L Greenway, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20980494
Citation
Solomon TP, Haus JM, Kelly KR, Cook MD, Filion J, Rocco M, Kashyap SR, Watanabe RM, Barkoukis H, Kirwan JP. A low-glycemic index diet combined with exercise reduces insulin resistance, postprandial hyperinsulinemia, and glucose-dependent insulinotropic polypeptide responses in obese, prediabetic humans. Am J Clin Nutr. 2010 Dec;92(6):1359-68. doi: 10.3945/ajcn.2010.29771. Epub 2010 Oct 27.
Results Reference
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PubMed Identifier
19793849
Citation
Solomon TP, Haus JM, Kelly KR, Cook MD, Riccardi M, Rocco M, Kashyap SR, Barkoukis H, Kirwan JP. Randomized trial on the effects of a 7-d low-glycemic diet and exercise intervention on insulin resistance in older obese humans. Am J Clin Nutr. 2009 Nov;90(5):1222-9. doi: 10.3945/ajcn.2009.28293. Epub 2009 Sep 30.
Results Reference
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Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

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