Clinical trial NCT02158897: Multi-cycle Prolon Diet
Official title: Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Safety and feasibility of the Prolon diet
timeFrame: 1 and half years
measure: Effect of Prolon diet on risk factors for metabolic syndrome and biomarkers of aging
timeFrame: 2 and half years
Secondary outcomes:
measure: Changes in cognitive functions before and after the dietary intervention.
timeFrame: 2 and half years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Davis School of Gerontology
state: California
Study officials:
References: