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

Obesity Clinical Trial

Official title: Evaluation of Longevity Diet and Fasting Mimicking Diet Programs on Body Composition, Disease Risk Factors, and Aging Markers: a Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This is a randomized, open-label in adult subjects: arm 1 will include subjects randomized to follow a Fasting Mimicking Diet (FMD) plan with a 5-day meal program once every two months for a 6-month period (3 cycles); arm 2 will include subjects randomized to follow the FMD plus a Longevity Diet (LD) program for a 6-month period (FMD+LD); arm 3 will include randomized to the control group that will be recommended to continue their usual diet. Participants belonging to the control arm will be given an opportunity to follow a 6-month LD program starting at the end of 6 months.

Recruitment

Participants with BMI >=25 kg/m2 and in the 30 to 65 year range will be identified in towns within of a range of 20 km from Varapodio (province of Reggio Calabria, Southern Italy).The confirmation of eligibility and subsequent consenting will be carried out at the screening visit.

Eligible participants will undergo 5 different visits (pre-screening visit, screening visit, baseline visit (t0), and two follow-up visits (after 3 and 6 months from the baseline visit). Participants belonging to the control arm who decide to follow an optional 6-month LD program at the last follow-up visit (month 6), will receive two additional visits at month 9 and at month 12.

Pre-screening phone call visit

The purpose of the pre-screening visit is to determine if a potential participant fits the study's core inclusion criteria (age and BMI) and doesn't meet some of its permanent exclusion criteria (e.g. morbidities, pregnancy, known allergies, etc.). Once a potential participant is cleared through the pre-screening visit and confirms interest in participating, he/she may proceed to the screening visit.

Screening visit

The purpose of the screening visit is to confirm the volunteer's eligibility for study participation. Participants who meet all inclusion/exclusion criteria, will be informed about the research study before any procedure is performed. Participants must provide written informed consent to the processing of personal data in an anonymous and aggregate form in compliance with the requirements of the EU General Data Protection Regulation 2016/679 (GDPR) and the relevant Italian laws implementing the GDPR, including the Legislative Decree No.101/2018 of 10 August 2018 on the protection of privacy in relation to the processing of personal data. Any collection, processing and disclosure of personal data, such as participant health and medical information is subject to compliance with the aforementioned personal data protection laws.

Screening will include measurement of height, weight, and vital signs, review of medical history and current medications, assessment of sleep quality and disturbances and collection of fasting blood. Participants will be then randomized into either one of the intervention arms (FMD or FMD+LD) or in the control arm using a web-based randomization system that will be controlled by the researchers of the Valter Longo Foundation in Milan

Baseline visit (T0)

Within a week from the screening visit, subjects in arm 1 and 2 (FMD or FMD+LD) will be given the box of FMD together with ketone test strips to self-monitor urinary ketone bodies during the FMD cycles. Subjects in arm 2 will be given informative material and instructions for the LD. During the visit, staff will administer the questionnaire for assessing life style and dietary habits. The baseline visit will also include body composition assessment using Bioelectrical Impedance Analysis (BIA), measurement of height, weight, and vital signs, medical history, current medications and a collection of fasting blood. Blood testing information will be also retried from the screening visit.

A portion of subjects for each study group reporting a sleep problem on the basis of the score obtained at the Pittsburgh Sleep Quality Index (PSQI) questionnaire will also receive an Oura Ring device for the continuous monitoring of sleep state and wakefulness. These three study groups will be balanced for age, sex, BMI and for the score obtained at the PSQI.

Visit 2 (after three months or 5-7 days after the second FMD cycle, T1)

After 3 months from the randomization, subjects in the FMD and FMD+LD arms will be contacted to receive the FMD boxes for the second and the third FMD cycles, respectively, together with the ketone test strips to self-monitor urinary ketone bodies during the FMD cycles. Visit 2 will also include body composition assessment using BIA, measurement of height, weight, and vital signs and to assess sleep quality and disturbances.

Visit 3 (after six months or 5-7 days after the third FMD cycle,T2)

During the clinical visit, staff will assess signs and symptoms of adverse events, review compliance to the diet programs. Visit 3 will also include body composition assessment using BIA, measurement of height, weight, and vital signs, medical history and current medications and a collection of fasting blood for both hematological and genetic analyses as previously described for the baseline visit. Only subjects who undergo home sleep monitoring at the baseline visit will also receive an Oura Ring device for the continuous monitoring of sleep state and wakefulness. After this period, study staff will assess sleep quality and disturbances with the PSQI and will answer any questions from the subject. At this point, subjects belonging to the control arm will be given an opportunity to follow a LD program for a 6-month period (optional).

Optional visit at month 9 and 12

Subjects belonging to the arm 3 who decide to follow an optional LD program for a 6-month period after the end of the study at 6 months will meet with the study nutritionist during the clinical visits at month 9 and month 12. Staff will review compliance to the LD program and answer any questions by the subject. ;

Related Conditions & MeSH terms

• Obesity
• Overweight
• Risk Behavior

• NCT number: NCT05698654
• Study type: Interventional
• Source: Fondazione Valter Longo
• Contact: Romina Inès Cervigni
• Phone: +390225138307
• Email: rcervigni@fondazionevalterlongo.org
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Completion date: January 30, 2025