Dietary Interventions for Diabetes Prevention

Recruiting in Palo Alto (17 mi)

Overseen by Tracey L McLaughlin, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Stanford University

Must not be taking: Diabetogenic, Weight loss

Disqualifiers: Major organ disease, Hypertension, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to prevent diabetes by creating personalized diet plans based on individual differences in how people develop the disease. It focuses on people with pre-diabetes or diabetes and uses biomarkers to diagnose and tailor diets early.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on diabetogenic medications (medications that can cause diabetes), you may not be eligible to participate.

What data supports the effectiveness of the treatment Precision Diets, Personalized Nutrition, Precision Nutrition for diabetes prevention?

Research suggests that precision nutrition, which tailors dietary advice based on individual characteristics like genetics and metabolism, can potentially be more effective in preventing type 2 diabetes compared to traditional approaches. Studies have shown that personalized dietary interventions can improve glycemic control (blood sugar management) and help manage risk factors for diabetes. ^{1 2 3 4 5}

Is precision nutrition safe for humans?

The research on precision nutrition, which tailors dietary advice based on individual characteristics like genetics and metabolism, does not report any specific safety concerns for humans. However, more studies are needed to confirm its safety and effectiveness compared to traditional nutrition approaches. ^{2 3 6 7 8}

How does the treatment Precision Diets differ from other treatments for diabetes prevention?

Precision Diets, or Precision Nutrition, is unique because it tailors dietary recommendations to an individual's genetic background, metabolic profile, and gut microbiome, unlike traditional one-size-fits-all approaches. This personalized strategy aims to optimize dietary response and improve health outcomes by considering personal characteristics and using advanced technologies like genomics and metabolomics. ^{2 3 9 10 11}

Research Team

Tracey L McLaughlin, MD

Principal Investigator

Stanford University

Michael P Snyder, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults over 18 who are not pregnant and do not have any major organ diseases, uncontrolled high blood pressure, or conditions affecting nutrient absorption like celiac disease. It's also important that participants haven't had significant weight changes recently, aren't heavy alcohol users, don't use weight loss drugs or follow specific diets, and haven't undergone bariatric surgery.

Inclusion Criteria

Not be pregnant, if female;

I am 18 years old or older.

Exclusion Criteria

Any medical condition that physicians believe would interfere with study participation or evaluation of results.

I am mentally capable and can understand and follow the study's requirements.

I do not have major organ disease, uncontrolled high blood pressure, am not pregnant or breastfeeding, do not use certain medications, and have not had significant weight changes or surgery for weight loss.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Metabolic Testing

Participants undergo metabolic tests including the Oral Glucose Tolerance Test, Insulin Sensitivity Test, and Isoglycemic Intravenous Glucose Infusion

4-8 weeks

3 visits (in-person)

Dietary Monitoring

Participants follow their own diet while using the CGM and test standardized foods

8-12 weeks

2 visits (in-person), 1 visit (virtual)

Dietary Counseling

Participants are counseled on reducing foods that cause glucose spikes and on macronutrient composition

8-12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in glycemic control and metabolic subphenotype classification

3 years

Treatment Details

Interventions

• Precision Diets (N/A)

Trial Overview The study aims to understand how different people develop pre-diabetes and diabetes by looking at their individual physiological differences. Researchers will try to find biomarkers for early diagnosis and create personalized diet plans to prevent the onset of diabetes more effectively.

Participant Groups

Group I: Optimizing Diet for Glycemic Control Experimental Treatment 1 Intervention

Phase 1: Metabolic testing will include 3 metabolic tests: 1. The Oral Glucose Tolerance Test. The participant will wear the CGM while undergoing the OGTT + will be asked to repeat the test at home twice. 2. The Insulin Sensitivity Test (Steady State Plasma Glucose). This test is designed to measure how well cells remove glucose from the blood in response to insulin. 3. The Isoglycemic Intravenous Glucose Infusion (IIGI). This test is designed to measure the incretin hormone effect. Phase 2: Participants follow their own diet while using the CGM. Participants are provided with 5-10 standardized foods to test during this phase. Phase 3: Participants are provided with additional standardized foods and counseled to continue their own diet during this phase. Phase 4: Participants are counseled on reducing or limiting the foods that caused glucose spikes and they are also counseled on macronutrient composition of their diet based on lipid profile.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Stanford, CA

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Patients Recruited

17,430,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Patients Recruited

299,000+

Findings from Research

In a study of 136 Japanese adults with type 2 diabetes, individualized dietary advice led to a greater reduction in HbA1c levels (-1.1%) compared to conventional dietary advice (-0.7%) over 6 months, indicating its effectiveness in managing blood sugar levels.

Participants receiving individualized advice also made healthier dietary changes, such as reducing energy intake and consumption of sweets and fats, which contributed to improvements in weight and lipid profiles, although these changes were not significantly different from the conventional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. Omura, Y., Murakami, K., Matoba, K., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision nutrition for prevention and management of type 2 diabetes. Wang, DD., Hu, FB.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Nutrition to Improve Risk Factors of Obesity and Type 2 Diabetes. Antwi, J.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research charting a course for evidence-based clinical dietetic practice in diabetes. Delahanty, LM.[2010]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. de Toro-Martín, J., Arsenault, BJ., Després, JP., et al.[2019]

Personalized nutrition (PN) interventions lead to greater improvements in dietary intake compared to generalized dietary advice, based on a systematic review of 11 randomized controlled trials involving 57 to 1488 participants across the US, Canada, and Europe.

The studies showed a low risk of bias and varied follow-up durations from 1 to 12 months, indicating that tailored dietary advice can be more effective, but further research is needed to explore different personalization methods and incorporate behavior-change techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. Jinnette, R., Narita, A., Manning, B., et al.[2023]

The gut microbiota plays a significant role in how individuals metabolize food and manage blood glucose levels, particularly in response to noncaloric artificial sweeteners.

There is considerable variability among individuals in their metabolic responses to the same foods, suggesting that dietary planning should be personalized, potentially using next-generation sequencing and bioinformatics to tailor nutrition strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing the gut microbiota to promote metabolic health. Zmora, N.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet® study. Nacis, JS., Labrador, JPH., Ronquillo, DGD., et al.[2023]

Precision nutrition, which seeks to customize dietary interventions based on individual genetic and biological data, holds great promise for addressing chronic diseases, but it is still largely theoretical with no validated clinical results yet.

Given the current lack of proven outcomes, it is important to approach the implementation of precision nutrition with caution, as it may not yet be ready for widespread clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Precision nutrition: handle with care.] Collecchia, G.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. Laddu, D., Hauser, M.[2019]

Medical nutrition therapy (MNT) has been a key component in three of the four largest long-term diabetes trials, highlighting its importance in both the prevention and treatment of diabetes.

The evidence suggests that dietetics professionals play a crucial role in initiating MNT early, which can lead to significant reductions in diabetes-related health issues and improve cost-effectiveness over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research navigating the course of clinical practice in diabetes. Delahanty, LM., Nathan, DM.[2005]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. [2022]

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

Precision nutrition for prevention and management of type 2 diabetes. [2022]

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

Precision Nutrition to Improve Risk Factors of Obesity and Type 2 Diabetes. [2023]

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

Research charting a course for evidence-based clinical dietetic practice in diabetes. [2010]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Precision Nutrition: A Review of Personalized Nutritional Approaches for the Prevention and Management of Metabolic Syndrome. [2019]

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

Does Personalized Nutrition Advice Improve Dietary Intake in Healthy Adults? A Systematic Review of Randomized Controlled Trials. [2023]

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

Harnessing the gut microbiota to promote metabolic health. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A study protocol for a pilot randomized controlled trial to evaluate the effectiveness of a gene-based nutrition and lifestyle recommendation for weight management among adults: the MyGeneMyDiet® study. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

[Precision nutrition: handle with care.] [2020]

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

Addressing the Nutritional Phenotype Through Personalized Nutrition for Chronic Disease Prevention and Management. [2019]

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

Research navigating the course of clinical practice in diabetes. [2005]