Lifestyle Intervention for Insulin Resistance

Overseen By Candida J Rebello, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Glucocorticoids, others

Disqualifiers: Type 2 diabetes, Type 1 diabetes, Gastrointestinal dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special diet and exercise program can assist older adults with insulin resistance and apathy (a lack of interest or motivation). It compares two groups: one following a diet that includes soy and another without soy. Participants receive all meals for 12 weeks and exercise under supervision to determine if these changes improve insulin levels and motivation. Ideal candidates are older adults who are sedentary (engaging in less than 90 minutes of exercise per week), have a BMI of 30 or higher, and experience low motivation. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance the quality of life for older adults.

Will I have to stop taking my current medications?

The trial requires that participants stop taking medications that significantly affect insulin resistance, obesity, cholesterol, triglycerides, metabolic rate, or those that significantly increase body weight. If you are on such medications, you may need to stop them to participate.

What prior data suggests that this diet and exercise program is safe for older adults with insulin resistance and apathy?

Research has shown that soy is generally safe for people with insulin resistance. Some studies have examined soy's effects on heart health, particularly in those with type 2 diabetes. These studies suggest that soy might improve heart health, indicating that it could be part of a heart-healthy diet.

One study examined soy's impact on blood sugar and insulin, which is crucial for those with insulin resistance. Although the changes were modest, there were positive effects, suggesting soy might help manage blood sugar levels, though it is not a cure-all.

Importantly, other research found that certain compounds in soy, called isoflavones, might enhance the body's use of insulin. This could benefit those managing insulin resistance.

Overall, soy is generally well-tolerated and poses no major safety concerns. It is often included in diets for its potential health benefits. However, as with any dietary change, individuals should monitor their body's response and discuss it with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary interventions for insulin resistance because they explore how specific dietary components, like soy, can directly impact blood glucose levels. Unlike standard treatments that often involve medications or generalized dietary advice, these diets focus on tailoring food choices to potentially moderate blood sugar more effectively. The diet with soy introduces a unique component that may offer additional benefits in managing insulin resistance, setting it apart from traditional dietary approaches. This focus on dietary modification provides a non-pharmacological option that could complement or even reduce the need for medication.

What evidence suggests that this trial's treatments could be effective for insulin resistance and apathy?

Research has shown that eating soy might help with insulin resistance. Some studies have found that soy products can improve how the body uses insulin, the hormone that controls blood sugar levels. A review found that certain components of soybeans enhance the body's ability to use sugar, potentially improving insulin sensitivity. However, other studies suggest that soy's effect on insulin and blood sugar isn't always strong. In this trial, participants will follow either a diet with soy or a diet without soy to evaluate these effects. Overall, while soy may offer some benefits, its effects can vary and may not work the same for everyone. ^{1 4 5 6 7}

Who Is on the Research Team?

Candida Rebello, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Apathy Evaluation Scale - score > 30 or GDS-15 Apathy subscale - score ≥ 2

Geriatric Depression Scale-15 (GDS-15) < 6

Mini-Mental State Examination (MMSE) > 25

Exclusion Criteria

I am taking medication that affects my insulin resistance, cholesterol, metabolism, or significantly increases my weight.

Participants that have had a fluctuation in body weight >5% in the preceding 2 months

Participants who have type 1 diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a diet and exercise program for 12 weeks, with meals provided and supervised exercise

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diet without soy
• Diet with soy

Trial Overview 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.

How Is the Trial Designed?

Group I: Diet with soy Experimental Treatment 1 Intervention

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

Group II: Diet without soy Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving Wistar fatty rats and their lean counterparts, it was found that dietary soybean protein combined with partially saturated beef tallow led to higher insulin receptor gene expression, which may help reduce insulin resistance.

Obese rats showed lower insulin receptor mRNA levels across all diets compared to lean rats, indicating that insulin resistance in obesity may be linked to defects in insulin receptor gene expression rather than just dietary fat or protein intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary soybean protein increases insulin receptor gene expression in Wistar fatty rats when dietary polyunsaturated fatty acid level is low. Iritani, N., Sugimoto, T., Fukuda, H., et al.[2018]

In a study involving over 63,000 women and 21,000 men, the consumption of soy foods like tofu and soy milk did not show a significant association with a reduced risk of type 2 diabetes (T2D).

However, higher intake of isoflavones, compounds found in soy, was linked to a modestly lower risk of T2D, suggesting that while soy foods alone may not be protective, the isoflavones they contain could contribute to diabetes risk reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumption of soy foods and isoflavones and risk of type 2 diabetes: a pooled analysis of three US cohorts. Ding, M., Pan, A., Manson, JE., et al.[2022]

In a study of 43,176 Chinese adults followed for an average of 5.7 years, higher consumption of unsweetened soy products was linked to a lower risk of developing type 2 diabetes, with significant reductions in risk observed at higher intake levels.

Conversely, the intake of sweetened soybean drinks was associated with an increased risk of diabetes, highlighting the importance of the type of soy product consumed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy intake and risk of type 2 diabetes in Chinese Singaporeans [corrected]. Mueller, NT., Odegaard, AO., Gross, MD., et al.[2022]

In a study of 1,148 adults in Tokushima, Japan, higher consumption of soya products, particularly non-fried varieties like miso soup, was linked to lower levels of insulin resistance, suggesting a protective effect against metabolic issues.

The research found a significant inverse relationship between the intake of soya protein and isoflavones and insulin resistance, indicating that increasing soya protein intake may help improve insulin sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inverse association between soya food consumption and insulin resistance in Japanese adults. Nakamoto, M., Uemura, H., Sakai, T., et al.[2023]

In a 4-year study involving 3,039 participants, higher intake of soybean products (four or more times per week) was linked to a significantly lower risk of developing type 2 diabetes, particularly in men with high BMI.

Men with high BMI who consumed soybean products regularly showed reduced incidences of both fasting and postload hyperglycemia, indicating that soybean intake may be beneficial for blood sugar control in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of soybean product intake on fasting and postload hyperglycemia and type 2 diabetes in Japanese men with high body mass index: The Saku Study. Tatsumi, Y., Morimoto, A., Deura, K., et al.[2022]

In a 12-week study involving 100 obese participants, those using a low-calorie soy-based meal replacement lost significantly more weight (7.00 kg) compared to the control group (2.90 kg), indicating its efficacy for weight loss.

The meal replacement program also led to greater reductions in total cholesterol and LDL cholesterol levels, suggesting additional cardiovascular benefits beyond weight loss, and it was well tolerated with no serious side effects reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial. Allison, DB., Gadbury, G., Schwartz, LG., et al.[2023]

In a study of 3,314 participants in Beijing, those who consumed soy products daily had a significantly lower risk of type 2 diabetes and impaired fasting glucose compared to those who consumed them less frequently.

The results suggest that regular soy consumption is associated with a reduced risk of diabetes, with odds ratios indicating a protective effect as consumption increased, highlighting the potential benefits of including soy in the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soy product consumption and type 2 diabetes among adults in Beijing, China. Zhu, Z., He, H., Zhou, J., et al.[2019]

In a study involving 163 participants with impaired fasting glucose, a dietary intervention with compound whole grain-soybean for six months significantly improved insulin sensitivity and reduced insulin resistance, as indicated by decreases in fasting blood glucose and insulin levels.

The intervention also led to significant reductions in body mass index and levels of certain adipocytokines, suggesting that this dietary approach can effectively enhance metabolic health in individuals at risk for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of compound whole grain-soybean on insulin resistance and serum adipocytokines in impared fasting glucose population]. Han, S., Zhang, H., Chi, J., et al.[2023]

A diet including 60 g/day of soy protein significantly reduced baseline blood sugar and triglyceride levels in type 2 diabetic patients, indicating improved metabolic control.

Incorporating 30 g/day of soy protein led to lower total cholesterol levels and helped maintain the hypoglycemic effects of the diet, suggesting that soy protein can be beneficial for managing cholesterol and blood sugar in diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of the combined food products with soy protein in diet therapy for patients with diabetes mellitus type 2]. Meshcheriakova, VA., Plotnikova, OA., Sharafetdinov, KhKh., et al.[2013]

A 4-week study involving 15 postmenopausal women showed that a diet rich in soy protein significantly improved insulin sensitivity compared to a mixed-protein diet, indicating potential benefits for metabolic health.

The soy-protein diet also led to a notable reduction in total cholesterol (4%) and LDL cholesterol (9%), suggesting that incorporating soy could be an effective strategy for preventing metabolic syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partly replacing meat protein with soy protein alters insulin resistance and blood lipids in postmenopausal women with abdominal obesity. van Nielen, M., Feskens, EJ., Rietman, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2570347/

EFFECTS OF SOY PROTEIN AND ISOFLAVONES ON ... Soy protein with isoflavones increases insulin secretion, increases insulin resistance, and decreases plasma adiponectin in male monkeys. Isoflavone-depleted ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523022712

Effects of soy intake on glycemic control: a meta-analysis ... Conclusions: There was not a significant overall effect of soy intake on improvements of fasting glucose and insulin concentrations; however, a favorable change ...

3. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)01820-8/fulltext

Effects of soy protein and isoflavones on glycemic control and ... The habitual intake of soy foods in our study population (12 g soy foods/d) may have neutralized the effect of soy on glycemic control and insulin sensitivity.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10058927/

Soy Consumption and the Risk of Type 2 Diabetes ... This meta-analysis demonstrated that soy consumption was negatively associated with the risks of T2D and CVDs and a specific quantity of soy products was the ...

5. mdpi.com mdpi.com/2072-6643/10/4/434

Rebelling against the (Insulin) Resistance: A Review of ... Bioactive compounds from soybeans and pulses have been investigated for their efficacy in improving glucose utilization and insulin sensitivity via increasing ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322000722

The Effects of Soy Products on Cardiovascular Risk Factors ... Our meta-analysis suggests that soy product consumption may improve cardiovascular parameters in patients with T2D, particularly in individuals with poor ...

7. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)02271-2/fulltext

Effects of soy intake on glycemic control: a meta-analysis of ... Conclusions: There was not a significant overall effect of soy intake on improvements of fasting glucose and insulin concentrations; however, a favorable change ...