Multi-cycle Prolon Diet
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 6/18/2016 |
| Start Date: | March 2013 |
| End Date: | June 2016 |
Effect of a Periodic Fasting-mimicking Diet on Risk Factors for Metabolic Syndrome and Age-related Diseases
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.
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.
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.
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.
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).
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