PrediabetesNCT06518798
Feasibility and Preliminary Effects of Fasting-Mimicking Diet in Asian Americans With Prediabetes
A study testing Fasting Mimicking Diet in people with Prediabetes and Prediabetic State, run by University of California, Irvine at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Prediabetes, Prediabetic State
- What is being tested?
- Fasting Mimicking Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 9 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Identify as Asian American
- Diagnosed with prediabetes according to at least one of the following:
- HbA1C 5.7%-6.4%
- Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L )
- Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours
Who cannot join
- Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions
- Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin
- Individuals who are pregnant or breastfeeding
- Individuals with anaphylaxis food allergies
- Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
- Individuals who have completed the FMD in the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on Fasting-Mimicking Diet in Asian Americans With Prediabetes
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:
Read more
- What are the recruitment, adherence, and attrition rates of eligible participants into the study?
- 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.
- Conditions
- Prediabetes, Prediabetic State
- Being tested
- Fasting Mimicking Diet
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking DietBehavioural
Participants will be instructed to follow their usual diet except for 5 days when they eat the foods in the FMD kit. The FMD consists of a blend of 100% plant based nutrients generally regarded as safe. One FMD kit provides for the replacement of the normal diet with plant products for five consecutive days. The formulation of these products was based on studies carried out at the Longevity Institute of the University of Southern California, led by Dr. Valter Longo and his collaborators over several decades of research.
| Study group | Role | What they receive |
|---|---|---|
| Fasting Mimicking Diet (FMD) | Experimental | 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. Receives: Behavioral: Fasting Mimicking Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate will be determined based on the number of individuals who consented to be in the pilot Fasting Mimicking Diet trial per month.
Measured: up to 6 months
Adherence rate
Study adherence will be assessed based on the participant's changes in fasting blood glucose and blood ketone levels measured pre- vs. post- Fasting Mimicking Diet (FMD); a post-FMD survey asking about adherence to the FMD; and attending the follow-up study appointment. The survey will also ask for participants' feedback on their experiences of the trial, including adverse events, and, if applicable, reasons for non-adherence, to enable further study optimization.
Measured: up to 6 months
Attrition rate
Attrition rate will be determined based on the number of individuals who stopped consuming the Fasting Mimicking Diet or never started.
Measured: up to 6 months
Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial
Willingness to participate in a future full FMD clinical trial (which would have 4 FMD cycles + additional study appointments at 4 months after the last FMD cycle) will also be assessed via survey at the conclusion of their participation in this pilot.
Measured: up to 6 months
Secondary outcomes (6)
Change in fasting blood glucose levels
Fasting blood glucose levels will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) (using a lancet and glucose meter)
Measured: Pre v. post 5-day FMD cycle
Change in blood pressure
Systolic and diastolic blood pressure will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Measured: Pre v. post 5-day FMD cycle
Change in body mass index
Body mass index will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Measured: Pre v. post 5-day FMD cycle
Change in percent body/visceral fat
Percent body fat and percent visceral fat will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Measured: Pre v. post 5-day FMD cycle
Change in waist circumference
Waist circumference will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
Measured: Pre v. post 5-day FMD cycle
Change in ketone levels
β-Hydroxybutyrate level will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD) using a lancet and blood ketone meter
Measured: Pre v. post 5-day FMD cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start12 Aug 2024
- Primary completion9 May 2025
- Study completion9 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Hannah Lui Park, University of California, Irvine
- Investigators
- Hannah Lui Park, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518798
- Sponsor's protocol ID
- 4223
- Status last verified
- Sep 2025
- First submitted
- 12 Jul 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be available from the corresponding author on reasonable request.
Publications
Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
PubMed 22683128Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
PubMed 11832527Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
PubMed 11333990Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.
PubMed 28202779Sulaj A, Kopf S, von Rauchhaupt E, Kliemank E, Brune M, Kender Z, Bartl H, Cortizo FG, Klepac K, Han Z, Kumar V, Longo V, Teleman A, Okun JG, Morgenstern J, Fleming T, Szendroedi J, Herzig S, Nawroth PP. Six-Month Periodic Fasting in Patients With Type 2 Diabetes and Diabetic Nephropathy: A Proof-of-Concept Study. J Clin Endocrinol Metab. 2022 Jul 14;107(8):2167-2181. doi: 10.1210/clinem/dgac197.
PubMed 35661214van den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle ME, Willems van Dijk K, Longo VD, Lamb HJ, Numans ME, Pijl H. 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. BMC Endocr Disord. 2020 Jun 24;20(1):94. doi: 10.1186/s12902-020-00576-7.
PubMed 32580710
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Fasting-Mimicking Diet in Asian Americans With Prediabetes
- ClinicalTrials.gov ID
- NCT06518798
- Acronym / sponsor ID
- 4223
- Conditions
- Prediabetes, Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 9 May 2025 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the recruitment, adherence, and attrition rates of eligible participants into the study?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting Mimicking Diet (FMD) | Experimental | Behavioral: Fasting Mimicking DietThe 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 may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Identify as Asian American
- Diagnosed with prediabetes according to at least one of the following:
- HbA1C 5.7%-6.4%
- Fasting blood glucose 100 to 125 mg/dL (5.6 to 6.9 mmol/L )
- Oral glucose tolerance test (OGTT) 140-199 mg/dL at two hours
Key exclusion criteria (6 listed)
- Individuals with a personal history of diabetes mellitus (ICD-10 codes E08-E13), cardiovascular disease, mental illness, drug dependency, pregnancy, and special dietary restrictions
- Individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin
- Individuals who are pregnant or breastfeeding
- Individuals with anaphylaxis food allergies
- Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting Mimicking DietParticipants will be instructed to follow their usual diet except for 5 days when they eat the foods in the FMD kit. The FMD consists of a blend of 100% plant based nutrients generally regarded as safe. One FMD kit provides for the replacement of the normal diet with plant products for five consecutive days. The formulation of these products was based on studies carried out at the Longevity Institute of the University of Southern California, led by Dr. Valter Longo and his collaborators over several decades of research. | Behavioural | Fasting Mimicking Diet (FMD) |
Primary outcome
Recruitment rate
Time frame: up to 6 months
Recruitment rate will be determined based on the number of individuals who consented to be in the pilot Fasting Mimicking Diet trial per month.
Adherence rate
Time frame: up to 6 months
Study adherence will be assessed based on the participant's changes in fasting blood glucose and blood ketone levels measured pre- vs. post- Fasting Mimicking Diet (FMD); a post-FMD survey asking about adherence to the FMD; and attending the follow-up study appointment. The survey will also ask for participants' feedback on their experiences of the trial, including adverse events, and, if applicable, reasons for non-adherence, to enable further study optimization.
Attrition rate
Time frame: up to 6 months
Attrition rate will be determined based on the number of individuals who stopped consuming the Fasting Mimicking Diet or never started.
Willingness to participate in a future full Fasting Mimicking Diet (FMD) clinical trial
Time frame: up to 6 months
Willingness to participate in a future full FMD clinical trial (which would have 4 FMD cycles + additional study appointments at 4 months after the last FMD cycle) will also be assessed via survey at the conclusion of their participation in this pilot.
6 secondary outcomes
Change in fasting blood glucose levels
Time frame: Pre v. post 5-day FMD cycle
Change in blood pressure
Time frame: Pre v. post 5-day FMD cycle
Change in body mass index
Time frame: Pre v. post 5-day FMD cycle
Change in percent body/visceral fat
Time frame: Pre v. post 5-day FMD cycle
Change in waist circumference
Time frame: Pre v. post 5-day FMD cycle
Change in ketone levels
Time frame: Pre v. post 5-day FMD cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 22683128Tabak AG, Herder C, Rathmann W, Brunner EJ, Kivimaki M. Prediabetes: a high-risk state for diabetes development. Lancet. 2012 Jun 16;379(9833):2279-90. doi: 10.1016/S0140-6736(12)60283-9. Epub 2012 Jun 9.
- Background: PubMed 11832527Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
- Background: PubMed 11333990Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Background: PubMed 28202779Wei M, Brandhorst S, Shelehchi M, Mirzaei H, Cheng CW, Budniak J, Groshen S, Mack WJ, Guen E, Di Biase S, Cohen P, Morgan TE, Dorff T, Hong K, Michalsen A, Laviano A, Longo VD. Fasting-mimicking diet and markers/risk factors for aging, diabetes, cancer, and cardiovascular disease. Sci Transl Med. 2017 Feb 15;9(377):eaai8700. doi: 10.1126/scitranslmed.aai8700.
- Background: PubMed 35661214Sulaj A, Kopf S, von Rauchhaupt E, Kliemank E, Brune M, Kender Z, Bartl H, Cortizo FG, Klepac K, Han Z, Kumar V, Longo V, Teleman A, Okun JG, Morgenstern J, Fleming T, Szendroedi J, Herzig S, Nawroth PP. Six-Month Periodic Fasting in Patients With Type 2 Diabetes and Diabetic Nephropathy: A Proof-of-Concept Study. J Clin Endocrinol Metab. 2022 Jul 14;107(8):2167-2181. doi: 10.1210/clinem/dgac197.
- Background: PubMed 32580710van den Burg EL, Schoonakker MP, van Peet PG, van den Akker-van Marle ME, Willems van Dijk K, Longo VD, Lamb HJ, Numans ME, Pijl H. 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. BMC Endocr Disord. 2020 Jun 24;20(1):94. doi: 10.1186/s12902-020-00576-7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be available from the corresponding author on reasonable request.
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah Lui Park, PhD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting Mimicking Diet in people with Prediabetes and Prediabetic State, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06518798, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.