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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special diet called the Fasting-Mimicking Diet (FMD) to determine its effectiveness for Asian Americans with prediabetes. The study aims to assess adherence to the diet and its impact on blood sugar levels. Participants will follow the diet for five days, with health measurements taken before and after. The study seeks Asian Americans diagnosed with prediabetes who do not have diabetes or other serious health conditions. As an unphased trial, it offers a unique opportunity to explore a new dietary approach to managing prediabetes.

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 prior data suggests that the Fasting-Mimicking Diet is safe for prediabetes?

Research has shown that the fasting-mimicking diet (FMD) is generally safe and easy for most people to follow. In one study, 71% to 95% of participants experienced no negative effects after six months on the FMD. Another study found that completing three cycles of a 5-day FMD each month was safe and aided in weight loss. These findings suggest that using the FMD for a short time, like the 5-day cycle in this trial, is unlikely to cause major issues for most people. However, as with any dietary change, consulting a healthcare provider first is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for prediabetes, which often include medications like metformin or lifestyle changes such as increased exercise and dietary adjustments, the fasting-mimicking diet (FMD) offers a unique approach by simulating the effects of fasting without requiring actual fasting. This diet provides specific nutrients that trick the body into a fasting state, potentially improving metabolic health and insulin sensitivity. Researchers are excited about FMD because it could offer a non-pharmaceutical option that might be easier for some people to adhere to compared to traditional fasting or medication regimens. Plus, it has the potential to provide benefits in a short, defined period, which can be appealing for those looking for timely results.

What evidence suggests that the Fasting-Mimicking Diet might be an effective treatment for prediabetes?

Research has shown that the Fasting-Mimicking Diet (FMD), which participants in this trial will follow, can improve blood sugar levels and other health indicators. One study found that people who followed the FMD had lower fasting blood sugar, aiding in prediabetes management. Another study discovered that FMD reduced insulin resistance, a major issue for those with prediabetes. The diet also decreased the need for diabetes medication and lowered the risk of diabetes-related problems. These findings suggest that FMD could be a promising way to improve health for people with prediabetes. ^{2 5 6 7 8}

Who Is on the Research Team?

Hannah Lui Park, PhD

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

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

Individuals who have completed the FMD in the past year

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

Individuals who are pregnant or breastfeeding

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/10-OR/159413/10-OR-Real-World-Outcomes-of-a-Fasting-Mimicking

10-OR: Real-World Outcomes of a Fasting Mimicking Diet ... Diabetes medication was reduced in 73% and 68% of patients at 3 and 6 months, respectively. Mean HbA1c decreased by 0.54% ± 0.84% at 3 months ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11153305/

Integration of a fasting-mimicking diet programme in ... In healthy (non-diabetic) humans, three 5-day cycles of FMD monthly were shown to reduce fat mass, BP, triglyceride levels and fasting glucose, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06518798

Feasibility and Preliminary Effects of Fasting-Mimicking ... 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098301524028468

Economic Evaluation of Fasting Mimicking Diet Versus ... This cost-utility analysis showed that the FMD program was associated with 11.4% less diabetes complications, 67.2% less overall diabetes medication use, and ...

5. nature.com nature.com/articles/s41467-024-45260-9

Fasting-mimicking diet causes hepatic and blood markers ... 3 FMD cycles in adult study participants are associated with reduced insulin resistance and other pre-diabetes markers, lower hepatic fat.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6816332/

Fasting-mimicking diet and markers/risk factors for aging ... This randomized phase 2 trial indicates that three cycles of a 5-day FMD per month are feasible, safe, and effective in reducing body weight, waist ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0939475325002650

A fasting-mimicking diet programme reduces abdominal ... A 12-month FMD programme reduced both aVAT and aSAT, while aMA remained unaffected compared to controls in persons with type 2 diabetes.

8. academic.oup.com academic.oup.com/jcem/article/107/8/2167/6576281

Six-Month Periodic Fasting in Patients With Type 2 Diabetes ... FMD was well tolerated with 71% to 95% of the participants reporting no adverse effects. After 6 months, change in ACR was comparable between ...