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Paleolithic Diet and Exercise Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00360516
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : June 29, 2011
Information provided by:
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Diet Behavioral: metabolic (nutrient controlled) diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Paleolithic Diets, Exercise Physiology and Metabolism
Study Start Date : November 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2007

Intervention Details:
  • Behavioral: metabolic (nutrient controlled) diet
    metabolic (nutrient controlled) diet

Primary Outcome Measures :
  1. validation of algorithm to predict diet net acid load [ Time Frame: 1year ]
    measuring 24-hour net acid and comparing this to the estimated diet acid load using one of several algorithms

Secondary Outcome Measures :
  1. effects of a "Paleolithic" diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and [ Time Frame: 1 year ]
    measuring VO2max, CO, BAR,

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00360516

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United States, California
UCSF 505 Parnassus Ave
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Lynda A Frassetto University of California, San Francisco
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Responsible Party: GCRC, UCSF Identifier: NCT00360516    
Other Study ID Numbers: H8748-27380-02
First Posted: August 4, 2006    Key Record Dates
Last Update Posted: June 29, 2011
Last Verified: June 2011
Keywords provided by University of California, San Francisco:
healthy volunteers