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DIETARY INTERVENTION IN HUMANS: A PILOT STUDY ON FEASIBILITY, SAFETY AND EFFECTS ON COGNITIVE AND IMMUNE FUNCTIONS

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.

Phase

N/A

Inclusion and Exclusion Criteria

  • 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).

Sites

  • California

    • Davis School of Gerontology, Los Angeles, California, 90089
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