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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting Mimicking Diet | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Pre v. post 5-day FMD cycle |
| Change in blood pressure |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hannah Lui Park, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine | Irvine | California | 92617 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22683128 | Background | 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. | |
| 11832527 | Background | Knowler 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. |
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De-identified individual participant data will be available from the corresponding author on reasonable request.
Starting 6 months after publication
Upon review by the study investigators
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Systolic and diastolic blood pressure will be compared pre v. post 5 days of Fasting Mimicking Diet (FMD)
| 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) | 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) | 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) | 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 | Pre v. post 5-day FMD cycle |
| 11333990 | Background | Tuomilehto 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. |
| 28202779 | Background | Wei 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. |
| 35661214 | Background | Sulaj 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. |
| 32580710 | Background | van 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. |
| D004700 | Endocrine System Diseases |