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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Diet with soy for insulin resistance?

Research shows that consuming soy foods is linked to lower insulin resistance, which means the body uses insulin more effectively. This suggests that a diet including soy might help improve insulin resistance. ^{1 2 3 4 5}

Is the soy-based diet safe for humans?

A study on a soy-based meal replacement for weight loss found it to be safe for obese individuals, suggesting that soy-based diets are generally safe for human consumption. ^{1 2 4 5 6}

How does the soy-based diet treatment for insulin resistance differ from other treatments?

The soy-based diet treatment for insulin resistance is unique because it involves replacing some meat with soy products, which has been shown to improve insulin sensitivity and lower cholesterol levels. This approach is different from standard treatments as it focuses on dietary changes rather than medication. ^{4 7 8 9 10}

Research Team

Candida Rebello, PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Soy intake and risk of type 2 diabetes in Chinese Singaporeans [corrected]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Consumption of soy foods and isoflavones and risk of type 2 diabetes: a pooled analysis of three US cohorts. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Soy product consumption and type 2 diabetes among adults in Beijing, China. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Inverse association between soya food consumption and insulin resistance in Japanese adults. [2023]

5. Japan 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

A novel soy-based meal replacement formula for weight loss among obese individuals: a randomized controlled clinical trial. [2023]

7. China pubmed.ncbi.nlm.nih.gov

[Effects of compound whole grain-soybean on insulin resistance and serum adipocytokines in impared fasting glucose population]. [2023]

8. Russia (Federation) 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]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Partly replacing meat protein with soy protein alters insulin resistance and blood lipids in postmenopausal women with abdominal obesity. [2023]

10. United States 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. [2018]