Multi-cycle Prolon Diet
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|ClinicalTrials.gov Identifier: NCT02158897|
Recruitment Status : Completed
First Posted : June 9, 2014
Last Update Posted : April 6, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Other: Prolon diet||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
No Intervention: Control
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.
Experimental: Prolon Diet
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
3 cycles of a 5-day Prolon diet very month
Other Name: Fasting-mimicking diet
- 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.
- 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.
- 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;
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Generally healthy adults
- BMI >19 kg/m^2
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158897
|United States, California|
|Davis School of Gerontology|
|Los Angeles, California, United States, 90089|
|Responsible Party:||Min Wei, Research assistant professor, University of Southern California|
|Other Study ID Numbers:||
|First Posted:||June 9, 2014 Key Record Dates|
|Last Update Posted:||April 6, 2017|
|Last Verified:||April 2017|