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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

1 in 3 adults have prediabetes in the United States, and many of them will eventually develop diabetes, which has significant public health and economic costs. However, type 2 diabetes (T2D) and prediabetes are heterogeneous groups with different pathological mechanisms, dysfunctions in different processes, and varied disease trajectories. Patient stratifications into subtypes and personalized nutrition interventions are highly needed but not yet available. Metabolic responses (e.g., glucose excursion) after food intake provide a direct observation of personal metabolic control and its association with T2D. The investigators hope to learn how prediabetes and type 2 diabetes evolve, and specifically what food or exercise can do to mitigate blood sugar response.

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 data supports the effectiveness of the treatment Dietary Intervention for Prediabetes?

Research shows that dietary interventions, such as healthy eating and active living education sessions, can help with weight reduction in people with prediabetes, which is important for managing the condition. ^{1 2 3 4 5}

Is the dietary intervention for prediabetes safe for humans?

Dietary interventions, such as plant-based diets and those low in saturated fats, are generally considered safe and beneficial for managing prediabetes and reducing cardiovascular risk factors. ^{2 6 7 8 9}

How does the dietary intervention treatment for prediabetes differ from other treatments?

The dietary intervention for prediabetes, focusing on fat-free mass-indexed feeding, is unique because it tailors nutritional intake to an individual's body composition, potentially offering a more personalized approach compared to standard low-calorie or low-glycemic diets. This method emphasizes adjusting dietary habits to improve body composition and metabolic health, which may not be the focus of other nutritional strategies. ^{2 6 10 11 12}

Research Team

Yue Wu, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A primary care based healthy-eating and active living education session for weight reduction in the pre-diabetic population. [2015]

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

Dietary assessment of pre-diabetic patients by using food frequency questionnaire. A systematic review of study quality, study outcome, study questionnaire and their relative validity and reliability. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Exploring the role of goal setting in weight loss for adults recently diagnosed with pre-diabetes. [2022]

4. 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]

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

Nutrition management for individuals with noninsulin-dependent diabetes mellitus in the 1990s: a review by the Diabetes Care and Education dietetic practice group. [2011]

6. China pubmed.ncbi.nlm.nih.gov

[Effects of lifestyle and quantitative nutrition interventions on individuals with prediabetes]. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Changes in dairy product consumption and subsequent type 2 diabetes among individuals with prediabetes: Tehran Lipid and Glucose Study. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Executive summary: Updates to the dietary treatment of prediabetes and type 2 diabetes mellitus. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Newly Developed Indicator of Overeating Saturated Fat Based on Serum Fatty Acids and Amino Acids and Its Association With Incidence of Type 2 Diabetes: Evidence From Two Randomized Controlled Feeding Trials and a Prospective Study. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Nutritional Strategies in Prediabetes: A Scoping Review of Recent Evidence. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A Mediterranean-Diet-Based Nutritional Intervention for Children with Prediabetes in a Rural Town: A Pilot Randomized Controlled Trial. [2023]

12. India pubmed.ncbi.nlm.nih.gov

Nutrition in prediabetes. [2017]