Paleolithic Diet in the Treatment of Glucose Intolerance

September 18, 2016 updated by: Staffan Lindeberg, Lund University Hospital
The purpose of this study is to determine whether a paleolithic diet improves glucose tolerance and insulin sensitivity in people with coronary heart disease and impaired glucose tolerance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is uncertainty about the optimal diet in the prevention and treatment of glucose intolerance and diabetes type 2, disorders which are very common in patients with coronary heart disease (CHD). Earlier studies have generally focused on intakes of fat, carbohydrate, fiber, fruit and vegetables. Another approach compares foods that were available during human evolution with more recently introduced ones. Twenty-nine CHD patients with glucose intolerance or diabetes have been randomized to 1) a Paleolithic ("Old Stone Age") diet (n=14) based on lean meat, fish, fruit, vegetables, root vegetables, eggs, and nuts, or 2) a Consensus (Mediterranean-like) diet (n=15) based on whole grains, low-fat dairy products, vegetables, fruit, fish, and oils and margarines generally assumed to be healthy. Primary outcome variables are changes during 12 weeks in weight, waist circumference, and area under the curve for glucose (AUC Glucose0-120) and insulin (AUC Insulin0-120) at the oral glucose tolerance test.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Hyperglycemia
  • Coronary Heart Disease
  • Increased waist circumference

Exclusion Criteria:

  • Body mass index <20 kg/m2
  • Serum creatinine >130 µmol/L
  • Poor general condition
  • Dementia
  • Unwillingness/inability to prepare food at home (by study participant or partner)
  • Participation in another medical trial
  • Chronic inflammatory bowel disease
  • Drug treatment with hypoglycemic agents
  • Drug treatment with warfarin
  • Drug treatment with oral steroid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paleolithic diet vs Mediterranean diet
Prudent diets with or without grains and dairy
Behavioral: Paleolithic diet vs Mediterranean diet
Prudent diets with or without grains and dairy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in weight and waist circumference
Time Frame: 12 weeks
12 weeks
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
Time Frame: 12 weeks
12 weeks
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting plasma glucose
Time Frame: 12 weeks
12 weeks
30-min plasma glucose
Time Frame: 12 weeks
12 weeks
120-min plasma glucose
Time Frame: 12 weeks
12 weeks
fasting plasma insulin
Time Frame: 12 weeks
12 weeks
30-min plasma insulin
Time Frame: 12 weeks
12 weeks
120-min plasma insulin
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: Staffan Lindeberg, MD PhD, Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 18, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LU 665-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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