Insulin SensitivityNCT05649176
Lifestyle Intervention for Improving Insulin Resistance and Concern for Health
A study testing Diet without soy and Diet with soy in people with Insulin Sensitivity and Apathy, run by Pennington Biomedical Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Insulin Sensitivity, Apathy
- What is being tested?
- Diet without soy and Diet with soy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2023to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: Lifestyle Intervention for Improving Metabolic and Motivational Outcomes
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.
Read more
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.
Read the 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.
- Conditions
- Insulin Sensitivity, Apathy
- Being tested
- Diet without soy, Diet with soy
- Medical subject headings
- Insulin Resistance, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet without soyOther
Also called Low glycemic index and reduced energy density
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the experimental diet but does not contain soy.
Diet with soyOther
Also called Low glycemic index and reduced energy density
The diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy.
| Study group | Role | What they receive |
|---|---|---|
| Diet without soy | Active comparator | Participants receive a diet to moderate the blood glucose response that does not include soy Receives: Other: Diet without soy |
| Diet with soy | Experimental | Participants receive a diet to moderate the blood glucose response that includes soy Receives: Other: Diet with soy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test
Measured: 12 weeks
Secondary outcomes (1)
Apathy as assessed by the Apathy Evaluation Scale
The score on the Apathy Evaluation Scale ranges from 18 to 72 with higher scores indicating greater apathy.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start13 Feb 2023
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insulin SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled two-arm parallel trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Candida Rebello, Pennington Biomedical Research Center
- Investigators
- Candida J Rebello, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05649176
- Sponsor's protocol ID
- PBRC 2022-028
- Other IDs
- 4R00AG065419-03
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2022
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20980494Solomon 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.
PubMed 19793849
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention for Improving Metabolic and Motivational Outcomes
- ClinicalTrials.gov ID
- NCT05649176
- Acronym / sponsor ID
- PBRC 2022-028
- Conditions
- Insulin Sensitivity, Apathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled two-arm parallel trial
| Arm | Type | Receives |
|---|---|---|
| Diet without soy | Active comparator | Other: Diet without soyParticipants receive a diet to moderate the blood glucose response that does not include soy |
| Diet with soy | Experimental | Other: Diet with soyParticipants receive a diet to moderate the blood glucose response that includes soy |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet without soyAlso: Low glycemic index and reduced energy densityThe diet is designed to moderate the blood glucose response with a similar macronutrient composition as the experimental diet but does not contain soy. | Other | Diet without soy |
| Diet with soyAlso: Low glycemic index and reduced energy densityThe diet is designed to moderate the blood glucose response with a similar macronutrient composition as the comparator diet but contains soy. | Other | Diet with soy |
Primary outcome
Insulin sensitivity
Time frame: 12 weeks
Insulin sensitivity will measured in a hyperinsulinemic euglycemic clamp test
1 secondary outcome
Apathy as assessed by the Apathy Evaluation Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 20980494Solomon 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.
- Background: PubMed 19793849Solomon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candida J Rebello principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet without soy and Diet with soy in people with Insulin Sensitivity and Apathy, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05649176, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.