Multi-cycle Prolon Diet

NCT02158897 | Completed Phase 1

• 1 other identifier: HS-12-00391
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  2 and half years

Study Arms (2)

Control

NO INTERVENTION

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.

Prolon Diet

EXPERIMENTAL

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

Interventions

Prolon diet OTHER

3 cycles of a 5-day Prolon diet very month

Also known as: Fasting-mimicking diet

Prolon Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Davis School of Gerontology

Los Angeles, California, 90089, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant professor

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 9, 2014
• Study Start: March 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (1)