Paleolithic Diet and Exercise Study

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00360516
First received: August 2, 2006
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Diet
Behavioral: metabolic (nutrient controlled) diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Paleolithic Diets, Exercise Physiology and Metabolism

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • validation of algorithm to predict diet net acid load [ Time Frame: 1year ] [ Designated as safety issue: No ]
    measuring 24-hour net acid and comparing this to the estimated diet acid load using one of several algorithms


Secondary Outcome Measures:
  • effects of a "Paleolithic" diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    measuring VO2max, CO, BAR,


Enrollment: 10
Study Start Date: November 2005
Study Completion Date: December 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: metabolic (nutrient controlled) diet
    metabolic (nutrient controlled) diet
Detailed Description:

Because genetic evolutionary changes occur slowly in Homo sapiens, and because the traditional diet of Homo sapiens underwent dramatic changes within recent times, modern humans are better physiologically adapted to a diet similar to the one their hominid ancestors evolved on than to the diet typical of modern industrialized societies. The investigators developed a computational model to estimate the net acid load of diets from the nutrient composition of the diet's component ingredients, and suggest that the majority of these hominid diets yield a negative net acid load (that is, yield a net base load), in addition to being low in sodium chloride, high in potassium-containing fruits and vegetables, and low in saturated fats, with the majority of the non-animal-source calories coming from fruits and vegetables, not from acid-producing grains, separated fats and oils, starches and refined sugars. According to paleonutritionists, Homo sapiens' recent switch from their ancestral Paleolithic-type diet to the modern Western diet has contributed in a major way to so-called age-related diseases of civilization. The investigators hypothesize and will test whether:

  1. consuming a high-potassium, low-sodium, net base-producing "Paleolithic-type" diet, even in the short term, has detectable beneficial effects on cardiovascular physiology, serum lipid profiles, insulin sensitivity, and exercise performance; and
  2. their computational model predicts the measured negative net acid loads of a net base-producing "Paleolithic-type" diet, using steady-state values of renal net acid excretion as the measure of the diet net acid load (a.k.a., net endogenous acid production), which will be of value in constructing net-base producing diets for modern consumption.

The long term complications of the combination of high blood pressure, high blood sugar and high fat and cholesterol levels, sometimes called the "metabolic syndrome", has been termed the number one medical problem in modern society today. 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360516

Locations
United States, California
UCSF 505 Parnassus Ave
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Lynda A Frassetto University of California, San Francisco
  More Information

Publications:
Responsible Party: GCRC, UCSF
ClinicalTrials.gov Identifier: NCT00360516     History of Changes
Other Study ID Numbers: H8748-27380-02
Study First Received: August 2, 2006
Last Updated: June 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
healthy volunteers

ClinicalTrials.gov processed this record on July 22, 2014