search
Back to results

Paleolithic Diet in the Treatment of Glucose Intolerance

Primary Purpose

Hyperglycemia, Coronary Heart Disease

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Paleolithic diet vs Mediterranean diet
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Lund University Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Paleolithic diet vs Mediterranean diet

Arm Description

Prudent diets with or without grains and dairy

Outcomes

Primary Outcome Measures

change in weight and waist circumference
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test

Secondary Outcome Measures

fasting plasma glucose
30-min plasma glucose
120-min plasma glucose
fasting plasma insulin
30-min plasma insulin
120-min plasma insulin

Full Information

First Posted
January 4, 2007
Last Updated
September 18, 2016
Sponsor
Lund University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00419497
Brief Title
Paleolithic Diet in the Treatment of Glucose Intolerance
Official Title
Paleolithic Diet in the Treatment of Glucose Intolerance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Coronary Heart Disease
Keywords
Paleolithic diet, Mediterranean-style diet, Glucose tolerance, Diabetes type 2, Weight loss, Waist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paleolithic diet vs Mediterranean diet
Arm Type
Active Comparator
Arm Description
Prudent diets with or without grains and dairy
Intervention Type
Behavioral
Intervention Name(s)
Paleolithic diet vs Mediterranean diet
Intervention Description
Prudent diets with or without grains and dairy
Primary Outcome Measure Information:
Title
change in weight and waist circumference
Time Frame
12 weeks
Title
area under the curve for glucose (AUC Glucose0-120) at the oral glucose tolerance test
Time Frame
12 weeks
Title
area under the curve for insulin (AUC Insulin0-120) at the oral glucose tolerance test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
fasting plasma glucose
Time Frame
12 weeks
Title
30-min plasma glucose
Time Frame
12 weeks
Title
120-min plasma glucose
Time Frame
12 weeks
Title
fasting plasma insulin
Time Frame
12 weeks
Title
30-min plasma insulin
Time Frame
12 weeks
Title
120-min plasma insulin
Time Frame
12 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staffan Lindeberg, MD PhD
Organizational Affiliation
Department of Clinical Sciences, IKVL 1, Lund University, Lund Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17583796
Citation
Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
Results Reference
result
PubMed Identifier
21118562
Citation
Jonsson T, Granfeldt Y, Erlanson-Albertsson C, Ahren B, Lindeberg S. A paleolithic diet is more satiating per calorie than a mediterranean-like diet in individuals with ischemic heart disease. Nutr Metab (Lond). 2010 Nov 30;7:85. doi: 10.1186/1743-7075-7-85.
Results Reference
derived

Learn more about this trial

Paleolithic Diet in the Treatment of Glucose Intolerance

We'll reach out to this number within 24 hrs