search
Back to results

Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study) (WDS)

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conjugated Linoleic Acid (CLA)
Safflower OIl
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring diabetes, conjugated linoleic acid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of Type 2 diabetes mellitus
  • obese
  • postmenopausal
  • HbA1c >6.49 and <14.1

Exclusion Criteria:

  • use of tobacco
  • substance abuse
  • impaired cognitive function
  • renal disease
  • abnormal liver function
  • gastrointestinal diseases
  • use of exogenous insulin
  • use of hormone replacement therapy currently or within past 6 months
  • pacemaker/defibrillator

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Safflower Oil

CLA 6.4g/day

Arm Description

8.0 g/day safflower oil

Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil

Outcomes

Primary Outcome Measures

change in plasma glucose AUC
significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.

Secondary Outcome Measures

change in insulin sensitivity
change in glucose tolerance
change in HbA1c
change in blood lipid profile
change in serum adipocytokines
change in hepatic enzymes
change in body composition

Full Information

First Posted
May 10, 2010
Last Updated
May 10, 2010
Sponsor
Ohio State University
Collaborators
Cognis
search

1. Study Identification

Unique Protocol Identification Number
NCT01121471
Brief Title
Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
Acronym
WDS
Official Title
Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ohio State University
Collaborators
Cognis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).
Detailed Description
The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
diabetes, conjugated linoleic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safflower Oil
Arm Type
Placebo Comparator
Arm Description
8.0 g/day safflower oil
Arm Title
CLA 6.4g/day
Arm Type
Experimental
Arm Description
Conjugated linoleic acid at a dose of 6.4g/day in a supplement with a total of 8.0g oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Conjugated Linoleic Acid (CLA)
Intervention Description
6.4 g CLA/day, capsule form, for 16 week arms
Intervention Type
Dietary Supplement
Intervention Name(s)
Safflower OIl
Intervention Description
8.0g/day safflower oil
Primary Outcome Measure Information:
Title
change in plasma glucose AUC
Description
significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.
Time Frame
baseline and week 16
Secondary Outcome Measure Information:
Title
change in insulin sensitivity
Time Frame
baseline and every 4 weeks until week 16
Title
change in glucose tolerance
Time Frame
baseline and every 4 weeks for 16 weeks
Title
change in HbA1c
Time Frame
baseline and week 16
Title
change in blood lipid profile
Time Frame
baseline and every 4 weeks for 16 weeks
Title
change in serum adipocytokines
Time Frame
baseline and every 4 weeks for 16 weeks
Title
change in hepatic enzymes
Time Frame
baseline and every 4 weeks for 16 weeks
Title
change in body composition
Time Frame
baseline and every 4 weeks for 16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of Type 2 diabetes mellitus obese postmenopausal HbA1c >6.49 and <14.1 Exclusion Criteria: use of tobacco substance abuse impaired cognitive function renal disease abnormal liver function gastrointestinal diseases use of exogenous insulin use of hormone replacement therapy currently or within past 6 months pacemaker/defibrillator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha A. Belury, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19535429
Citation
Norris LE, Collene AL, Asp ML, Hsu JC, Liu LF, Richardson JR, Li D, Bell D, Osei K, Jackson RD, Belury MA. Comparison of dietary conjugated linoleic acid with safflower oil on body composition in obese postmenopausal women with type 2 diabetes mellitus. Am J Clin Nutr. 2009 Sep;90(3):468-76. doi: 10.3945/ajcn.2008.27371. Epub 2009 Jun 17.
Results Reference
result

Learn more about this trial

Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

We'll reach out to this number within 24 hrs