Multi-cycle Prolon Diet

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158897
• Other study ID #: HS-12-00391
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 2, 2014
• Last updated: April 4, 2017
• Start date: March 2013
• Est. completion date: June 2016

Study information

• Verified date: April 2017
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Prolon diet
3 cycles of a 5-day Prolon diet very month

Locations

Country	Name	City	State
United States	Davis School of Gerontology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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