Fasting-mimicking Diet and Longevity Diet, Body Composition and Aging

NCT05698654 | Unknown

• 1 other identifier: 2023-UCALPRG-0004259
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as a large, randomized, controlled clinical trial in a heterogeneous population and is aimed at assessing as a primary objective whether the fasting-mimicking diet alone or in combination with the longevity diet can modify the percentage of fat mass in a cohort of subjects stratified by sex, age and body mass index. As secondary objectives, will evaluate the effects of the fasting-mimicking diet alone or in combination with the longevity diet on the general health conditions of the population. From a public health point of view, the efficacy of a food intervention such as the longevity diet and/or short periods of fasting-mimicking diet would represent proof of the results that can be achieved by a realistics, feasible and inexpensive approach. The information obtained is relevant because the nutritional intervention will be undertaken by people who live in their normal environment and who simply receive every day dietary guidelines, and support and/or boxes containing a 5 day meal program to be consumed in lieu of their normal diet once every 3 months.

Conditions

Overweight; Risk Behavior; Obesity

Keywords

Fasting; Fasting-mimicking diet; Longevity Diet; Longevity; Diet; Aging; FMD; Nutrition; Diseases; LD; Clinical Trial; Randomized; Health; Fat Mass

Outcome Measures

Primary Outcomes (1)

• Body Fat Percentage

  Change from baseline to end of study in body composition measured as percentage of fat mass.

  Comparison of the clinical marker up to 7 days after the randomization and 6 months after the randomization (6 months)

Secondary Outcomes (10)

• Change of blood glucose values

  Comparison of the clinical marker up to 7 days after the randomization and 6 months after the randomization (6 months)

• Change of blood insulinemic values

  Comparison of the clinical marker up to 7 days after the randomization and 6 months after the randomization (6 months)

• Change of blood glycated hemoglobin

  Comparison of the clinical marker up to 7 days after the randomization and 6 months after the randomization (6 months)

• Change of blood LDL, HDL, total cholesterol and triglycerides

  Comparison of the clinical marker up to 7 days after the randomization and 6 months after the randomization (6 months)

• Change of blood pressure

  Comparison of the clinical marker up to 7 days after the randomization and 6 months after the randomization (6 months)

Study Arms (3)

Fasting-mimicking diet (FMD)

EXPERIMENTAL

The fasting-mimicking diet (FMD) group, will be instructed on the benefits and use of the fasting-mimicking diet and how it should be used. This group will have to perform the fasting-mimicking diet once every 3 months (3 cycles in 6 months).

Behavioral: Fasting-mimicking diet (FMD)

Longevity diet and Fasting-mimicking diet (LD + FMD)

EXPERIMENTAL

This group will undergo both nutritional interventions (LD + FMD); the nutritionist will provide information on the longevity diet andpotential the fasting-mimicking diet, highlighting the advantages of following them. The subjects will be instructed to follow 3 FMD cycles (one cycle every 3 months as for arm 1) combined with the longevity diet plan. The longevity diet includes parts unrelated to diet and involving physical exercise.

Behavioral: Longevity Diet (LD) + Fasting-mimicking Diet (FMD)

Control Group

NO INTERVENTION

Participants in this arm will undergo the same testing as the intervention groups but will be instructed to continue their usual diet. Participants belonging to the control arm will be given an opportunity to follow a 6-month additional LD program starting at the end of 6 months. This trial makes use of a control group to provide robust evidence on the effects of nutritional interventions on the primary and secondary endpoints.

Interventions

Fasting-mimicking diet (FMD) BEHAVIORAL

The subjects will be instructed to follow their usual diet plan, except for 5 days when they eat the foods in the FMD box.The fasting-mimicking diet consists of a blend of 100% plant based nutrients generally regarded as safe. The formulation of these products is based on studies carried out at the Longevity Institute of the University of Southern California and his collaborators over several decades of studies. This food plan provides for the replacement of the normal diet with the organic plant products contained in the fasting-mimicking diet for five consecutive days.

Fasting-mimicking diet (FMD)

Longevity Diet (LD) + Fasting-mimicking Diet (FMD) BEHAVIORAL

The subjects will be instructed to follow their longevity diet plan, except for 5 days when they eat the foods in the FMD box, based on the following guidelines: vegan based diet with the addition of low mercuryfish 2-3 times a week; protein content should be 0.7-0.8 grams per kilogram of ideal weight per day (most of the protein coming from whole cereals,vegetables, legumes and tree nuts only part from fish); monounsaturated and polyunsaturated fats are predominant and very low amounts of saturated and trans-fats are allowed; complex Carbohydrates from vegetables, whole grains and legumes; addition of vitamins, minerals and Omega3 fats; food selected between the traditional food consumed by ancestry; time-restricted feeding: all food must be consumed within 12 hours each day. for those who are overweight or are nearly overweight (BMI \>25 kg/m2), either lunch or dinner will be substituted with a low calorie, low sugar snack (approximately 100 kcal: salad, nuts, fruit, etc.).

Longevity diet and Fasting-mimicking diet (LD + FMD)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of 30-65 years of age;
• Body mass index equal to or greater than 25 kg/m2.
• And at least one of the following:
• Obesity (Body mass index equal to or greater than 30 kg/m2).
• HbA1C greater than 5.6%;
• IGF-1 level greater than 200 ngml-1;
• Systolic blood pressure \>130 mmHg and diastolic blood pressure \>90 mmHg;
• Triglycerides \>150 mgdl-1;
• C-reactive protein \>1 mgL-1;
• Total cholesterol \>190 mgdL-1 and LDL cholesterol \>129 mgdL-1.

You may not qualify if:

• individuals with a family member already included in the study;
• individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac;
• pregnant females;
• Individuals with any documented cancer diagnosis within the past 5 years;
• documented myocardial infarction within past 5 years;
• documented cerebrovascular accident within past 5 years;
• chronic steroid use (longer than 45 consecutive days);
• insulin-dependent diabetes mellitus;
• individuals taking insulin or insulin-like drugs and individuals taking hypoglycemic agents other than metformin. In this last case, close attention will therefore be paid to the self-monitoring of blood glucose during the FMD cycles;
• Individuals with severe hypertension (systolic greater than 200 mmHg and or diastolic greater than 105 mmHg.
• Change in prescription medications, over-the-counter (OTC) medications, medical foods, and nutritional supplements within 30 days prior to the start and for the duration of the study.
• Use of medications classified as narcotics 15 days prior start and for the duration of the study.
• Use of prescription medications and/or over-the-counter medications for acute and semi- acute medical conditions 15 days prior to start and for the duration of the study.
• Use of acetaminophen is permitted on an as-needed basis.
• Use of an investigational drug or participation in an investigational study within 30 days prior to the start and for the duration of the study.

Sponsors & Collaborators

• Fondazione Valter Longo: lead
• University of Calabria: collaborator
• University of Palermo: collaborator
• Regione Calabria / Comune Varapodio: collaborator
• IFOM ETS - The AIRC Institute of Molecular Oncology: collaborator
• European Longevity Institute: collaborator

Study Sites (1)

Ambulatorio Medico presso Biblioteca Comunale

Varapodio, Calabria, 89010, Italy

RECRUITING

Related Publications (7)

• Knoops KT, de Groot LC, Kromhout D, Perrin AE, Moreiras-Varela O, Menotti A, van Staveren WA. Mediterranean diet, lifestyle factors, and 10-year mortality in elderly European men and women: the HALE project. JAMA. 2004 Sep 22;292(12):1433-9. doi: 10.1001/jama.292.12.1433.

  PMID: 15383513 BACKGROUND

• Brandhorst S, Choi IY, Wei M, Cheng CW, Sedrakyan S, Navarrete G, Dubeau L, Yap LP, Park R, Vinciguerra M, Di Biase S, Mirzaei H, Mirisola MG, Childress P, Ji L, Groshen S, Penna F, Odetti P, Perin L, Conti PS, Ikeno Y, Kennedy BK, Cohen P, Morgan TE, Dorff TB, Longo VD. A Periodic Diet that Mimics Fasting Promotes Multi-System Regeneration, Enhanced Cognitive Performance, and Healthspan. Cell Metab. 2015 Jul 7;22(1):86-99. doi: 10.1016/j.cmet.2015.05.012. Epub 2015 Jun 18.

  PMID: 26094889 BACKGROUND

• Houston M, Hays L. Acute effects of an oral nitric oxide supplement on blood pressure, endothelial function, and vascular compliance in hypertensive patients. J Clin Hypertens (Greenwich). 2014 Jul;16(7):524-9. doi: 10.1111/jch.12352. Epub 2014 Jun 24.

  PMID: 24962851 BACKGROUND

• Gallus S, Odone A, Lugo A, Bosetti C, Colombo P, Zuccaro P, La Vecchia C. Overweight and obesity prevalence and determinants in Italy: an update to 2010. Eur J Nutr. 2013 Mar;52(2):677-85. doi: 10.1007/s00394-012-0372-y. Epub 2012 May 27.

  PMID: 22645105 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.

  PMID: 28202779 BACKGROUND

• Levine ME, Suarez JA, Brandhorst S, Balasubramanian P, Cheng CW, Madia F, Fontana L, Mirisola MG, Guevara-Aguirre J, Wan J, Passarino G, Kennedy BK, Wei M, Cohen P, Crimmins EM, Longo VD. Low protein intake is associated with a major reduction in IGF-1, cancer, and overall mortality in the 65 and younger but not older population. Cell Metab. 2014 Mar 4;19(3):407-17. doi: 10.1016/j.cmet.2014.02.006.

  PMID: 24606898 BACKGROUND

• Pollack MN. Insulin, insulin-like growth factors, insulin resistance, and neoplasia. Am J Clin Nutr. 2007 Sep;86(3):s820-2. doi: 10.1093/ajcn/86.3.820S.

  PMID: 18265475 BACKGROUND

MeSH Terms

Conditions

Overweight; Risk-Taking; Obesity; Fasting; Disease

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Pathologic Processes

Study Officials

• Romina Inès Cervigni

  Fondazione Valter Longo

  STUDY DIRECTOR

• Alberto Montesanto

  Department of Biology, Ecology and Earth Sciences, University of Calabria

  STUDY CHAIR

Central Study Contacts

Romina Inès Cervigni

CONTACT

+390225138307; rcervigni@fondazionevalterlongo.org

Alberto Montesanto

CONTACT

+3930984492901; alberto.montesanto@unical.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 26, 2023
• Study Start: January 30, 2023
• Primary Completion: July 30, 2024
• Study Completion: January 30, 2025
• Last Updated: June 13, 2023

Record last verified: 2023-01

Locations

IT (1)