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Completed

NCT Number: NCT02158897

Multi-cycle Prolon Diet

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Davis School of Gerontology

Los Angeles, California, 90089, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prolon diet

Other

3 cycles of a 5-day Prolon diet very month

Other names: Fasting-mimicking diet

Primary outcomes

  1. Safety and feasibility of the Prolon diet

    Time frame: 1 and half years

    Phase I: To obtain preliminary estimates of the feasibility and safety of a low calorie Prolon diet in adult subjects.

  2. Effect of Prolon diet on risk factors for metabolic syndrome and biomarkers of aging

    Time frame: 2 and half years

    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.

Secondary outcomes

  1. Changes in cognitive functions before and after the dietary intervention.

    Time frame: 2 and half years

    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;

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2014
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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