Clinical trial NCT05649176: Lifestyle Intervention for Improving Insulin Resistance and Concern for Health
Official title: Lifestyle Intervention for Improving Metabolic and Motivational Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Sensitivity
Apathy
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled two-arm parallel trial
Primary purpose: TREATMENT

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:

1. Does the diet and exercise program improve insulin resistance and apathy?
2. 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:

1. A diet to moderate the blood glucose response that contains soybean; and
2. 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.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 30kg/m2
* Mini-Mental State Examination (MMSE) \> 25
* Geriatric Depression Scale-15 (GDS-15) \< 6
* Apathy Evaluation Scale - score \> 30 or GDS-15 Apathy subscale - score ≥ 2
* Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3
* Sedentary: \< 90 minutes of moderate to vigorous physical activity/week.

Exclusion Criteria:

* Subjects with a diagnosis of Type 2 diabetes received more than five years ago.
* 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.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: 12 weeks
measure: Apathy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Candida J Rebello
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.