Multi-cycle Prolon Diet

Completed · Phase 1/Phase 2

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT02158897

Run by

University of Southern California

People needed

102

Starts

2013-03-01

Expected to finish

2016-06-01

Last updated by the study team

2017-04-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

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

Full record on ClinicalTrials.gov

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