Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome

NCT00548782 | Completed

• 1 other identifier: H84763129001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology. We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• decreased insulin secretion

  2 months

Study Arms (2)

A

ACTIVE COMPARATOR

Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured. a paleolithic diet excludes dairy, grains, legumes and processed foods.

Other: Paleolithic diet

B

ACTIVE COMPARATOR

Subjects will be placed on ADA ( American Diabetes Association) recommended diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured. An ADA diet is lower fat and more whole grains.

Other: ADA ( American Diabetes Association) recommended diet

Interventions

Paleolithic diet OTHER

diet

A

ADA ( American Diabetes Association) recommended diet OTHER

diet

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients
• Age \>= 18 yrs
• BMI \< 40 kg/m2
• Normal cardiac, renal and hepatic function

You may not qualify if:

• Subjects on thiazolidinediones ( Avandia, Actos) or other medications that interfere with the testing procedures
• Subjects unwilling or unable to follow the diet specified
• Pregnant women
• Subjects who are unable to understand the consent form
• Hematocrit less than 30
• Patients with defibrillators

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Paleolithic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Franca Angeli, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Umesh Masharani, MRCP

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Lynda Frassetto, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Shelley MCCoy

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 24, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2016
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)