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Paleolithic Diet and Exercise Study

Paleolithic Diets, Exercise Physiology and Metabolism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00360516
Enrollment
10
Registered
2006-08-04
Start date
2005-11-30
Completion date
2007-12-31
Last updated
2011-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet

Keywords

healthy volunteers

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.

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.

Interventions

BEHAVIORALmetabolic (nutrient controlled) diet

metabolic (nutrient controlled) diet

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
validation of algorithm to predict diet net acid load1yearmeasuring 24-hour net acid and comparing this to the estimated diet acid load using one of several algorithms

Secondary

MeasureTime frameDescription
effects of a Paleolithic diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and1 yearmeasuring VO2max, CO, BAR,

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026