Fasting-Mimicking Diet for Prediabetes

Overseen By Mirian Kang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Insulin, Hypoglycemics

Disqualifiers: Diabetes, Cardiovascular, Mental illness, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 week

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking insulin or insulin-like drugs and hypoglycemic agents other than metformin. If you are on these medications, you may not be eligible to participate.

What data supports the effectiveness of the Fasting-Mimicking Diet treatment for prediabetes?

Research shows that a low-carbohydrate and energy deficit diet, similar to a fasting-mimicking diet, can significantly reduce prediabetes prevalence and improve blood sugar control compared to lifestyle changes alone. Additionally, various nutritional strategies, including low-calorie diets, have been effective in managing prediabetes by improving blood sugar and weight. ^{1 2 3 4 5}

Is the Fasting-Mimicking Diet safe for humans?

The Fasting-Mimicking Diet (FMD) is designed to mimic the benefits of fasting while allowing some food intake, and it has been studied for its effects on metabolic health. While specific safety data for FMD in prediabetes is limited, similar dietary approaches like intermittent fasting have been compared to continuous diets in people with type 2 diabetes, suggesting they are generally safe. However, individual responses can vary, and it's important to consult with a healthcare provider before starting any new diet. ^{1 4 6 7 8}

How does the Fasting-Mimicking Diet treatment differ from other treatments for prediabetes?

The Fasting-Mimicking Diet is unique because it mimics the effects of fasting while allowing some food intake, which may help improve blood sugar control without the need for strict calorie restriction or complex meal planning, unlike other diets that focus on low carbohydrates or specific food orders. ^{1 2 5 9 10}

What is the purpose of this trial?

This is a pilot study to determine the feasibility of studying the Fasting-Mimicking Diet (FMD), a dietary approach that involves the consumption of a specifically formulated, calorie-restricted nutrition regimen with a customized macronutrient composition, ratio, and quantity over a 5- day period, on a larger scale in Asian Americans with prediabetes and to examine the preliminary effects of the diet in study participants. The main questions the study aims to answer are: 1. What are the recruitment, adherence, and attrition rates of eligible participants into the study? 2. Does one FMD cycle result in changes in fasting blood glucose levels and physical measurements in study participants? Participants will be asked to undergo one cycle of FMD (for 5 days), fill out surveys, and come in for a pre-FMD and post-FMD study visit, during which physical measurements and fasting blood glucose and ketone levels will be measured.

Research Team

Hannah Lui Park, PhD

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for Asian Americans who have prediabetes, a condition where blood sugar levels are higher than normal but not high enough to be type 2 diabetes. Participants should be willing to follow a Fasting-Mimicking Diet (FMD) for 5 days and attend pre- and post-diet study visits.

Inclusion Criteria

Identify as Asian American

I have been diagnosed with prediabetes based on blood tests.

Exclusion Criteria

I have a history of diabetes, heart disease, mental illness, drug dependency, am pregnant, or have dietary restrictions.

Individuals who have completed the FMD in the past year

Individuals who are pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one cycle of the Fasting-Mimicking Diet (FMD) for 5 days

1 week

2 visits (in-person): pre-FMD and post-FMD

Follow-up

Participants are monitored for changes in fasting blood glucose, ketone levels, and physical measurements

up to 6 months

1 follow-up visit (in-person)

Treatment Details

Interventions

• Fasting-Mimicking Diet

Trial Overview The study tests the feasibility of the Fasting-Mimicking Diet in this population and its preliminary effects on fasting blood glucose levels and body measurements. It involves one cycle of FMD over five days with surveys and health checks before and after.

Participant Groups

Group I: Fasting Mimicking Diet (FMD) Experimental Treatment 1 Intervention

The fasting-mimicking diet (FMD) group will be instructed on the benefits and use of the FMD kit. Participants will be given one 5-day FMD kit at their baseline visit. They will be instructed to follow the kit, and only eat its items, for five consecutive days and to report back for a follow-up visit and measurements at the end of their 5 days before returning to their normal diet.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Findings from Research

In a study with 15 participants with prediabetes, changing the order of food consumed during a meal significantly reduced post-meal glucose spikes, with the 'protein and vegetables first' (PVF) order leading to a 38.8% lower glucose response compared to 'carbohydrate first' (CF).

The 'vegetables first' (VF) meal condition also resulted in significantly lower insulin levels compared to CF, indicating that meal order can be an effective strategy to stabilize blood sugar levels in individuals with prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of food order on postprandial glycaemic excursions in prediabetes. Shukla, AP., Dickison, M., Coughlin, N., et al.[2020]

Intermittent fasting (IF) and continuous energy-restricted diets (CERD) showed similar effects on glycemic control in patients with type 2 diabetes and metabolic syndrome, based on a meta-analysis of four studies with 355 participants.

However, IF resulted in greater weight loss compared to CERD, indicating it may be a beneficial dietary approach for overweight or obese patients with these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. Wang, X., Li, Q., Liu, Y., et al.[2021]

In a study involving 225 adults with prediabetes, a personalized postprandial-targeting (PPT) diet led to significantly greater improvements in glycemic control compared to a Mediterranean (MED) diet, as evidenced by a larger reduction in daily time spent with glucose levels above 140 mg/dL and lower HbA1c levels after 6 months.

Both diets were effective in reducing glucose levels, but the PPT diet showed a mean reduction of 1.3 hours per day above 140 mg/dL and a decrease in HbA1c of 0.16%, compared to 0.3 hours and 0.08% for the MED diet, with these benefits maintained at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes. Ben-Yacov, O., Godneva, A., Rein, M., et al.[2022]

In a study involving 44 participants (25 with normal fasting glucose and normal glucose tolerance, and 19 with normal fasting glucose but impaired glucose tolerance), insulin-stimulated glucose disposal was found to be significantly lower in those with impaired glucose tolerance, indicating a defect in insulin action.

The research concluded that the issues leading to impaired glucose tolerance are not due to defects in liver glucose production but rather due to impaired insulin action and β-cell function, highlighting the importance of insulin sensitivity in managing prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms Underlying the Pathogenesis of Isolated Impaired Glucose Tolerance in Humans. Varghese, RT., Dalla Man, C., Sharma, A., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Prediabetes Conversion to Normoglycemia Is Superior Adding a Low-Carbohydrate and Energy Deficit Formula Diet to Lifestyle Intervention-A 12-Month Subanalysis of the ACOORH Trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Interventions for the Prevention of Type 2 Diabetes in High-Risk Groups: Current State of Evidence and Future Research Needs. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The impact of food order on postprandial glycaemic excursions in prediabetes. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Intermittent fasting versus continuous energy-restricted diet for patients with type 2 diabetes mellitus and metabolic syndrome for glycemic control: A systematic review and meta-analysis of randomized controlled trials. [2021]

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

Fasting in diabetes treatment (FIT) trial: study protocol for a randomised, controlled, assessor-blinded intervention trial on the effects of intermittent use of a fasting-mimicking diet in patients with type 2 diabetes. [2022]

8. China pubmed.ncbi.nlm.nih.gov

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

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

Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes. [2022]

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

Mechanisms Underlying the Pathogenesis of Isolated Impaired Glucose Tolerance in Humans. [2018]