Multi-cycle Prolon Diet

Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases

Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Furthermore, STS improves risk factors associated with aging and age-related disease in rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in a pilot human trial. The objective of the study is to ascertain the impact of the fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months. The investigators hypothesize that the specially designed dietary regimen can reduce the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Prolon diet

Detailed Description

The Phase I part of the study is designed as a randomized cross-over trial, including two arms: a Control arm and a multi-cycle special 5-day dietary regimen (Diet, 3 cycles) arm. After 3 cycles, the Control and Diet groups are crossed over such that the Control group will under-go dieting and the Diet group will return to normal diet. Participants will be monitored for body weight and physiological changes, as well as the adherence to the dietary intervention.

The Phase II part of the study is an expansion of the Phase I to ascertain the impact of the dietary intervention on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.

Statistical methods: Paired samples t-test and Mann-Whitney test will be used to compare between Control and Diet groups as well as pre- and post-diet values.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90089
      • Davis School of Gerontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Generally healthy adults
• BMI >19 kg/m^2

Exclusion Criteria:

• Severe hypertension (systolic BP > 200 mm Hg and/or diastolic BP > 105 mm Hg).
• Underweight (BMI < 19 kg/m^2)
• Females who are pregnant or nursing
• Special dietary requirements incompatible with the study interventions
• Significant food allergies which would make the subject unable to consume the study food
• Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will consume their normal diet. Body weight and physiological change at two time points (approximately 2-3 months apart) will be examined. The participants will be crossed over to the diet group.
Experimental: Prolon Diet; Participants will be provided with a 5-day supply of fasting-mimicking diet, including energy bars, soups, drink packets and dietary supplements. Participants will diet for 3 cycles. Each one-month cycle consists of 5 days of dieting with a calorie intake estimated at 600-1200 calories per day. The rest of the month participants will eat normally. After 3 cycles, participants will be examined again after consuming their normal diet after 2-3 months.	Other: Prolon diet; 3 cycles of a 5-day Prolon diet very month; Other Names: Fasting-mimicking diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and feasibility of the Prolon diet	Phase I: To obtain preliminary estimates of the feasibility and safety of a low calorie Prolon diet in adult subjects.	1 and half years
Effect of Prolon diet on risk factors for metabolic syndrome and biomarkers of aging	Phase II: To ascertain the impact of the calorie restricted special diet on the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases: e.g. fasting glucose, glucose tolerance, blood pressure, abdominal obesity, lipid profile, circulating IGF-1 and IGFBP1.	2 and half years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cognitive functions before and after the dietary intervention.	Effects of dieting on the brain using fMRI; Effects of dieting on cognitive functions: Verbal memory and learning;; Speed of processing/attention;; Working memory;; Executive function;; Visuospatial construction and memory;; Frequency of Forgetting;	2 and half years

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 2, 2014
• First Submitted That Met QC Criteria: June 5, 2014
• First Posted (Estimate): June 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 6, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HS-12-00391