Dietary Interventions for Diabetes Prevention

Overseen By Caroline Bejikian, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Diabetogenic, Weight loss

Disqualifiers: Major organ disease, Hypertension, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals develop pre-diabetes and diabetes, focusing on a personalized prevention approach through diet. Researchers aim to identify specific bodily signals indicating diabetes development and use this information to tailor diet recommendations, known as Precision Diets. Participants will undergo tests to understand their body's response to sugar and insulin (a hormone that helps control blood sugar) and then receive dietary counseling based on their results. Individuals experiencing blood sugar issues or suspecting a risk for diabetes might be well-suited for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to personalized diabetes prevention strategies.

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 prior data suggests that these dietary interventions are safe for diabetes prevention?

Research shows that precision diets are generally safe and easy to follow. Studies have found that personalized nutrition can help manage diabetes and improve health without causing major side effects. For instance, many people experienced better blood sugar control with customized diets, which can help prevent diabetes from worsening.

Precision diets aim to match food choices to a person's specific health needs. This method has succeeded in many cases, with few reports of negative effects. Overall, evidence suggests that precision diets are a safe option for managing or preventing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the precision diets for diabetes prevention because they offer a personalized approach to managing blood sugar levels, unlike standard treatments that often involve medications like metformin or insulin therapy. This method uses Continuous Glucose Monitors (CGM) to track real-time glucose levels, allowing for tailored dietary advice that considers individual responses to different foods. The approach emphasizes reducing foods that cause glucose spikes and adjusting macronutrient intake based on personal lipid profiles. By focusing on individualized dietary interventions, this strategy aims to optimize glycemic control more effectively than conventional one-size-fits-all approaches.

What evidence suggests that precision diets might be an effective treatment for diabetes prevention?

Studies have shown that precision diets, which customize nutrition for each person, can effectively manage and prevent type 2 diabetes. In this trial, participants will follow precision diets tailored to their unique body responses to help control blood sugar levels. Research indicates that precision diets can be more effective than standard diets because they focus on what works best for each individual. Initial findings also highlight the development of a personalized glycemic sensitivity index, which helps predict how different foods will affect blood sugar. Overall, precision nutrition shows promise for better diabetes prevention and management by adapting to individual differences. ^{3 6 7 8 9}

Who Is on the Research Team?

Tracey L McLaughlin, MD

Principal Investigator

Stanford University

Michael P Snyder, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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;

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Precision Diets

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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

Published Research Related to This Trial

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]

Precision nutrition, which tailors dietary recommendations based on individual characteristics like genetics and metabolism, shows significant promise in effectively improving risk factors for obesity and type 2 diabetes, as highlighted by recent research.

This approach addresses the limitations of traditional dietary interventions by providing personalized strategies that can lead to better behavior change and health outcomes, suggesting it could be a more effective alternative in managing these chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Precision nutrition (PN) aims to provide personalized dietary recommendations based on an individual's genetics, metabolic profile, and environment, which can help prevent and treat chronic diseases more effectively.

This approach recognizes that traditional dietary guidelines may not be sufficient for everyone, as individual responses to diet can vary significantly, highlighting the need for tailored nutritional strategies.

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]

Precision nutrition, which tailors dietary recommendations based on an individual's genetics, metabolism, and environment, shows promise in preventing and managing type 2 diabetes through personalized dietary interventions.

Despite advances in technology and research, the field faces challenges such as high costs, methodological issues, and the need for more robust evidence to support its efficacy compared to traditional nutrition strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

Nutrition and lifestyle interventions have been crucial in three major diabetes clinical trials, showing their effectiveness in preventing diabetes and reducing complications for individuals with diabetes.

Dietitians played a key role in these trials by not only implementing nutrition plans but also tailoring their approaches to individual participants, which helped improve outcomes like blood sugar control and weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

This study will investigate whether personalized nutrition and lifestyle recommendations based on individual genotypes can lead to greater weight loss and reductions in BMI, waist circumference, and body fat percentage among 62 overweight and obese adults over a 12-month period.

The trial will be the first to implement a gene-based intervention with intensive counseling followed by a free-living simulation, aiming to provide evidence for the effectiveness of precision nutrition in weight management.

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]

Personalized nutrition, informed by recent advances in nutrigenomics and deep phenotyping, is crucial for effectively addressing the rising rates of obesity and metabolic disorders like type 2 diabetes and cardiovascular diseases.

A collaborative effort among scientists and health professionals is essential to translate scientific findings into practical dietary recommendations that can be implemented at the population level, enhancing the prevention and management of metabolic syndrome.

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12350580/

Effectiveness of Personalized Nutrition on Management ... Studies that provide data on the effectiveness of personalized nutrition compared to control diet. Studies published in full-text format in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213858718300378

Precision nutrition for prevention and management of type ... Precision nutrition aims to prevent and manage chronic diseases by tailoring dietary interventions or recommendations to one or a combination of an individual' ...

3. journals.lww.com journals.lww.com/pn/fulltext/2025/09000/precision_nutrition_for_preventing_type_2_diabetes.2.aspx

Precision nutrition for preventing type 2 diabetes mellitus .. ... Precision nutrition is one of the promising methods that have been used for approaching the variation in individuals' responses to diet, nutrients, metabolic ...

4. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(25)00201-1/fulltext

Quantification of personalized glycemic sensitivity to food and ... A pivotal outcome of this study is the development of a diet-independent metric, the personalized glycemic sensitivity index (PGS), which ...

5. link.springer.com link.springer.com/article/10.1007/s00125-022-05721-6

Precision nutrition in diabetes: when population-based ... This article reviews the clinical evidence supporting precision nutrition as a fundamental approach for dietary advice in diabetes.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2772566922000416

Personalized nutrition for people with diabetes and at risk ... We argue that personalized/precision nutrition in combination with future foods can act as medicines for people with diabetes or at risk of diabetes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12474561/

Personalized Nutrition in the Era of Digital Health The integration of digital health technologies with personalized nutrition offers a transformative approach for managing diabetes and obesity.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11397555/

Precision or Personalized Nutrition: A Bibliometric Analysis The objective of PN is to improve health and prevent, manage, and treat diseases through the development of nutrition approaches, by using ...

9. mdpi.com mdpi.com/2072-6643/16/10/1479

Do Precision and Personalised Nutrition Interventions ... Consistent and significant improvements favouring PPN and MNT interventions were reported across studies that examined outcomes like HbA1c, PPG, ...