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Low-Intermediate-Glycemic Index Caribbean Foods Versus High Glycemic Index Foods in Type 2 Diabetes

Primary Purpose

Type 2 Diabetes, Inflammation, Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Jamaica
Study Type
Interventional
Intervention
Low-Intermediate-Glycemic Index diets
High GI diet
Sponsored by
University Hospital of the West Indies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • between the age group of 25-65 years who have been previously clinically diagnosed with type 2 diabetes mellitus.
  • Subjects were required to have low activity jobs, for example, clerical jobs

Exclusion Criteria:

  • Individuals with Impaired glucose tolerance (IGT)
  • Diabetics who were treated with insulin
  • Subjects who were on hypertensive medications
  • Individuals who are polycythemic or anemic
  • Type 2 diabetics who participate in vigorous exercise Persons with chronic disease other than diabetes making a 3-year survival improbable as well as other medical characteristics that are likely to interfere with their participation in the study, for example, subjects with unbalanced clinical conditions, such as thyroid and liver disease, which could interfere with glucose metabolism; alcoholism or inability to effectively participate in a dietary programme

Sites / Locations

  • University of the West Indies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low-Intermediate-Glycemic Index diets

High GI diet

Arm Description

Outcomes

Primary Outcome Measures

Glycated Haemoglobin

Secondary Outcome Measures

body weight, homocysteine, C-reactive protein, plasma lipids and lipoproteins, fasting body glucose, insulin, insulin resistance, serum urea, creatinine, C-peptide

Full Information

First Posted
January 6, 2009
Last Updated
January 6, 2009
Sponsor
University Hospital of the West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT00818935
Brief Title
Low-Intermediate-Glycemic Index Caribbean Foods Versus High Glycemic Index Foods in Type 2 Diabetes
Official Title
Glycemic Indices of Caribbean Foods and Application in Dietary Lifestyle Intervention for Management of Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital of the West Indies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether low and intermediate GI Caribbean foods are effective in the management of type 2 diabetes.
Detailed Description
Recruitment: Subjects for the study were sourced primarily from the University Hospital of the West Indices (Diabetic Clinic) and from the Diabetes Association of Jamaica Outreach Centers in Kingston and St. Catherine. Volunteers were also recruited through clinical visits and by opportunistic population screenings and by placing advertisements in local newspapers and by distributing similar advertisements to the diabetes clinic and diabetes education programs. Information Sessions: Approximately 112 volunteers in groups of 10-30 with or without spouses will attend one of a number of evening information sessions at run from the Department of Basic Medical Sciences (Biochemistry Section), University of the West Indies. During the sessions the exact nature of the study will be described and volunteers will have the opportunity to ask specific questions about the study. Screening: Potential subjects will then fill in and return to the investigators a detailed questionnaire concerning their medical history, medications (including vitamin, mineral and nutritional supplements) smoking habits, alcohol intake and exercise pattern and whether they are currently on a specific diet. Details will also be obtained concerning planned vacations. Those subjects deemed potentially eligible will be asked to give a fasting blood sample at the Biotechnology Center, University of the West Indies. Individuals who meet the study criteria, are invited to return again to the Department. The principles of the diabetic diet which they are already expected to be following will be reinforced by the study nutritionist whereby consuming a diet with more than 50% of daily calories from carbohydrate; less than 10% from saturated fat and 20% from mono- and polyunsaturated fat, or up to 25% if the surplus is from monounsaturated fat; cholesterol less than 300 mg/day; and approximately 1.0 g protein per kg ideal weight per day. An increase in the intake of dietary fiber to 15 g per 1000 kcal was encouraged. All subjects were then randomized to one 24-week treatment in a two-treatment parallel design. Treatments: 1) low glycemic index dietary advice (e.g. to eat intact grain cereals, boiled green banana, boiled sweet potato, boiled round leaf yellow yams and boiled breadfruit) 2) high cereal fiber diet. Background diets will be the subjects' diabetic diets, modified as above, which will conform. Diet histories will be recorded at weekly for 24 weeks. These diets will be assessed for consistency by the dietitian in the subject's presence through dietary recall and semi-quantitative assessment of food portion sizes consumed. Where necessary, modifications in diet will be made to ensure weight maintenance. Compliance will be assessed by 7 day food records. Duration: the study will consist of four months recruitment and patient selection, during which time estimation of individual caloric requirements will be performed, and 6 months treatment period. Study Details: Fasting blood samples were obtained at day zero and weeks 2, 4, 8, 12, 16 and 24 of each study period. Twenty-four hour urine for urinary C-peptide analyses will be obtained immediately prior to the beginning of the study and at the end of each 24-week treatment phase. Palatability and satiety: subjects will record their ratings using a 9-point bipolar semantic scale at weekly intervals during each study phase. Anthropometric measures: height at recruitment, waist and hip circumference, and body composition will be taken immediately prior to and at the end of each study phase. Body weight and blood pressure will be measured at clinic visits. This study will help to indicate whether a low-intermediate-GI indigenous Caribbean foods dietary advice can reduce the postprandial glycemia, inflammation and cardiovascular risks in person with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Inflammation, Cardiovascular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-Intermediate-Glycemic Index diets
Arm Type
Experimental
Arm Title
High GI diet
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-Intermediate-Glycemic Index diets
Intervention Type
Dietary Supplement
Intervention Name(s)
High GI diet
Primary Outcome Measure Information:
Title
Glycated Haemoglobin
Time Frame
6 months
Secondary Outcome Measure Information:
Title
body weight, homocysteine, C-reactive protein, plasma lipids and lipoproteins, fasting body glucose, insulin, insulin resistance, serum urea, creatinine, C-peptide
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: between the age group of 25-65 years who have been previously clinically diagnosed with type 2 diabetes mellitus. Subjects were required to have low activity jobs, for example, clerical jobs Exclusion Criteria: Individuals with Impaired glucose tolerance (IGT) Diabetics who were treated with insulin Subjects who were on hypertensive medications Individuals who are polycythemic or anemic Type 2 diabetics who participate in vigorous exercise Persons with chronic disease other than diabetes making a 3-year survival improbable as well as other medical characteristics that are likely to interfere with their participation in the study, for example, subjects with unbalanced clinical conditions, such as thyroid and liver disease, which could interfere with glucose metabolism; alcoholism or inability to effectively participate in a dietary programme
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof Helen N Asemota, PhD
Organizational Affiliation
Univeristy of the West Indies
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the West Indies
City
Kingston
Country
Jamaica

12. IPD Sharing Statement

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Low-Intermediate-Glycemic Index Caribbean Foods Versus High Glycemic Index Foods in Type 2 Diabetes

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