Paleolithic Diet and Exercise Study
Paleolithic Diets, Exercise Physiology and Metabolism
1 other identifier
interventional
10
1 country
1
Brief Summary
If eating a "Paleolithic" diet helps improve these diseases, this would be the first step in both improving people's health as they get older as well as contributing to future national dietary guidelines for Americans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 29, 2011
June 1, 2011
1.8 years
August 2, 2006
June 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
validation of algorithm to predict diet net acid load
measuring 24-hour net acid and comparing this to the estimated diet acid load using one of several algorithms
1year
Secondary Outcomes (1)
effects of a "Paleolithic" diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and
1 year
Interventions
metabolic (nutrient controlled) diet
Eligibility Criteria
You may qualify if:
- Age \>= 18 years and \<= 55 years
- On no medications
- Body mass index (BMI) between 18 and 29.9 kg/m2
- Normal renal and hepatic function
- Subjects who report moderate intensity exercising \<= three times a week for 30 minutes or less, who then qualify by exercise testing with a VO2max at or below age- and gender-matched controls
You may not qualify if:
- Subjects who must follow a specific diet
- Subjects on any daily medications
- Subjects unwilling to follow the diet specified
- Subjects unable to do the exercise testing
- Pregnant women
- Subjects who are unable to understand the consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF 505 Parnassus Ave
San Francisco, California, 94143, United States
Related Publications (2)
Sebastian A, Frassetto LA, Sellmeyer DE, Merriam RL, Morris RC Jr. Estimation of the net acid load of the diet of ancestral preagricultural Homo sapiens and their hominid ancestors. Am J Clin Nutr. 2002 Dec;76(6):1308-16. doi: 10.1093/ajcn/76.6.1308.
PMID: 12450898BACKGROUNDFrassetto L, Morris RC Jr, Sellmeyer DE, Todd K, Sebastian A. Diet, evolution and aging--the pathophysiologic effects of the post-agricultural inversion of the potassium-to-sodium and base-to-chloride ratios in the human diet. Eur J Nutr. 2001 Oct;40(5):200-13. doi: 10.1007/s394-001-8347-4.
PMID: 11842945BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynda A Frassetto
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
November 1, 2005
Primary Completion
September 1, 2007
Study Completion
December 1, 2007
Last Updated
June 29, 2011
Record last verified: 2011-06