Paleolithic Diet and Exercise Study

Diet Clinical Trial

Official title:

Paleolithic Diets, Exercise Physiology and Metabolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360516
• Other study ID #: H8748-27380-02
• Status: Completed
• Phase: N/A
• First received: August 2, 2006
• Last updated: June 28, 2011
• Start date: November 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diet

Intervention

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

Locations

Country	Name	City	State
United States	UCSF 505 Parnassus Ave	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

Frassetto 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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	effects of a "Paleolithic" diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and	measuring VO2max, CO, BAR,	1 year	No