Dietary Intervention for Prediabetes

Overseen By Dalia Study Dietitian

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Diabetogenic, Weight loss

Disqualifiers: Major organ diseases, Pregnancy, Alcohol, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different foods can help control blood sugar levels in people with prediabetes or type 2 diabetes. Participants will consume specific foods to test their effects on blood sugar after a rice meal. The goal is to identify dietary changes that can help manage or slow the progression of diabetes. Ideal candidates for this trial live near Stanford, have prediabetes or type 2 diabetes managed with diet or metformin, and are generally healthy without major organ diseases. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new dietary strategies for managing diabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on diabetogenic medications, except for metformin. If you are taking metformin, you can continue using it during the study.

What prior data suggests that this dietary intervention is safe for prediabetes?

Research has shown that dietary changes can be safe and well-tolerated for individuals with prediabetes and type 2 diabetes. One study found that a Mediterranean diet benefited children with prediabetes in a rural area without causing serious side effects. Another study demonstrated that dietary changes can help manage type 2 diabetes, though the optimal approach remains under investigation.

Regarding safety, a study on a low glycemic load diet (which limits foods that quickly raise blood sugar) reported no significant negative changes in weight, BMI (body mass index), or muscle mass over eight weeks. This suggests that dietary changes are generally safe and do not cause harmful side effects in the short term. Overall, these findings support the safety of dietary changes for managing blood sugar levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach to managing prediabetes, which often involves medications or general lifestyle advice, this dietary intervention is unique because it focuses specifically on how different foods can directly mitigate blood sugar spikes after consuming rice. Researchers are excited about this trial because it offers a targeted, natural method to control blood sugar levels through diet, potentially reducing the need for medications. By pinpointing specific foods that can help manage glucose levels, this approach could empower individuals with prediabetes to make more informed dietary choices, offering a personalized and proactive way to manage their condition.

What evidence suggests that this dietary intervention might be an effective treatment for prediabetes?

Research shows that changing one's diet can help manage prediabetes. This trial will test different foods to assess their effect on blood sugar levels after a rice meal. Studies have found that personalized meal plans can help control blood sugar in people with prediabetes. In one study, participants who followed a customized diet for 26 weeks had better glucose levels. Other research suggests that certain diet changes might even reverse prediabetes. Additionally, dietary changes can improve other health factors like insulin and cholesterol levels. These findings support the idea that specific foods can help manage and possibly reverse prediabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Yue Wu, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for generally healthy adults over 18 living near Stanford who have prediabetes or type 2 diabetes managed by diet or metformin. Participants must not be pregnant, have cognitive impairments, malabsorptive disorders, major organ diseases, a history of bariatric surgery, heavy alcohol use, recent significant weight change, or be on certain medications.

Inclusion Criteria

Be willing to provide written informed consent for all study procedures

I feel healthy and have no noticeable symptoms.

Not be pregnant

Exclusion Criteria

I have a condition that affects how my body absorbs nutrients, like celiac disease.

I am currently using weight loss medications or following a specific diet.

You have gained or lost more than 2 kilograms in the last three weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Monitoring

Participants use a Continuous Glucose Monitor (CGM) and Fitbit to track blood sugars and activity for 10 days, while following specific dietary and exercise instructions.

10 days

Daily monitoring (remote)

Optional Repetition

5 participants may volunteer to repeat the 10-day monitoring cycle three times.

30 days

Follow-up

Participants are monitored for changes in metabolic states and glucose levels after the intervention period.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dietary intervention

Trial Overview The study aims to understand how different foods and exercises affect blood sugar control in people with prediabetes and type 2 diabetes. It will involve dietary interventions to see if personalized nutrition can help manage these conditions.

How Is the Trial Designed?

Group I: mitigator Experimental Treatment 1 Intervention

Test different foods to see their mitigating effect on blood sugars after a rice meal.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

Citations

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

Effectiveness of Personalized Nutrition on Management ... Assessment of the impact of a personalised nutrition intervention in impaired glucose regulation over 26 weeks: a randomised controlled trial.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825003391

The efficacy of dietary interventions for prediabetes ... Literature suggested that prediabetes may be reversible through dietary interventions. Despite numerous meta-analyses evaluating the efficacies of dietary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7650618/

Nutritional Strategies in Prediabetes: A Scoping Review of ... The most frequently assessed outcomes were plasma glucose, serum insulin, serum lipid profile, body mass index and body weight. More than 50% of reported ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02535169

Lifestyle-Related Health Outcomes in Prediabetes and ... At baseline, before the interventions described in Aims 1 and 2, can associations between glycemia, cardiometabolic risk factors, and diet and physical activity ...

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(23)66120-9/fulltext

The effectiveness of medical nutrition therapy provided by a ... In adults with prediabetes, MNT was effective in improving glycemic outcomes, anthropometrics, blood pressure, and most lipid levels. However, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10780530/

Diabesity and Dietary Interventions: Evaluating the Impact of ... A pilot RCT demonstrated that MD-based nutritional intervention in children with pre-diabetes in a rural region showed that the MD significantly decreased ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39563447/

Associations of the fat-free mass index and ... Both the FMI and the FFMI significantly correlated with the danger of developing diabetes and prediabetes, and the correlations are approximately linear.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0022316624003456

Effects of Breastfeeding Promotion Intervention and Dietary ... This dietary intervention reduced weight in Swedish lactating women with overweight and obesity by 9% [28] and reduced waist circumference, total cholesterol, ...

9. nutritionandmetabolism.biomedcentral.com nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-025-00968-3

Effects of 12 nutritional interventions on type 2 diabetes Numerous trials confirm dietary interventions benefit type 2 diabetes mellitus (T2DM) management, but the optimal model is unclear.

10. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1441201/full

Safety and tolerability of a low glycemic load dietary ... Data from our current study showed no significant changes in weight, BMI or lean mass over the 8-week intervention period, but did show several ...