NCT01047280

Brief Summary

The purpose of the study is to examine how a naturally occurring fat found in meats, such as beef and lamb and milk, called conjugated linoleic acid (CLA), will affect your body weight and body fat content, blood fat levels, as well as selected safety parameters. The CLA will be supplemented in an oil form and will be added to solid foods as provided by the metabolic kitchen at the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2006

Typical duration for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
Last Updated

January 12, 2010

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

January 8, 2010

Last Update Submit

January 11, 2010

Conditions

Body WeightBody CompositionHyperlipidemiaInflammationOxidative Stress

Keywords

Conjugated linoleic acidBody weightBody compositionBlood lipid profileBody inflammatory and oxidative status

Outcome Measures

Primary Outcomes (1)

  • Changes in body weight, body fat mass, and lean body mass

    At baseline and endpoint of each phase

Secondary Outcomes (1)

  • Changes in inflammation and oxidation markers

    At baseline and endpoint of each phase

Study Arms (3)

Safflower oil

PLACEBO COMPARATOR

This arm of the study constitutes the control phase

Dietary Supplement: Safflower oil

Clarinol G-80®

EXPERIMENTAL
Dietary Supplement: Clarinol G-80 ® treatment

G-c9, t11

EXPERIMENTAL
Dietary Supplement: G-c9, t11

Interventions

Clarinol G-80 ® treatmentDIETARY_SUPPLEMENT

dietary supplement of 3.5g/day 50-50 mixture of t10, c12 and c9, t11 CLA. In addition, the amount of mixed natural tocopherols is 5mg/g (0.05%).

Clarinol G-80®
Safflower oilDIETARY_SUPPLEMENT

3.5 g/d of safflower oil

Safflower oil
G-c9, t11DIETARY_SUPPLEMENT

3.5 g/day of c9, t11 CLA

G-c9, t11

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Study subjects will be defined as overweight or obese, hyperlipidemic males, with a LDL-C level of greater than 2.5 mmol/L.Subjects will be between 18-60 years old and must have a body mass index (BMI) of 25-36 kg/m2. Subjects with thyroid diseases will be included in the study as long as they have been shown to be stable in response to their medications and thyroid therapy will have to be maintained at a stable dose throughout the study.

You may not qualify if:

  • subjects taking medications and/or natural health products known to affect lipid metabolism (cholestyramine, colestipol, niacin, clofibrate, gemfibrozil, probucol, HMG CoA reductase inhibitors, high dose dietary supplements or fish oil capsules (\> 4 g/day), guggul, lecithin, evening primrose oil within the last six months. In addition subjects will no be allowed to consume any of these medications during the study;
  • subjects who have taken plant sterol supplements within the past six weeks and consume plant sterol supplements during the trial;
  • subjects who smoke or consume large amounts of alcohol (\> 2 drinks/day);
  • subjects who have any major food allergies or are vegetarian;
  • subjects that use natural or pharmaceutical weight loss supplements or products known to affect lipid metabolism at the beginning and end of each treatment period as well as the washout periods;
  • subjects who are sensitive to the Asteraceae/Compositae family (e, g., ragweed, marigolds, daisies).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Joseph SV, Jacques H, Plourde M, Mitchell PL, McLeod RS, Jones PJ. Conjugated linoleic acid supplementation for 8 weeks does not affect body composition, lipid profile, or safety biomarkers in overweight, hyperlipidemic men. J Nutr. 2011 Jul;141(7):1286-91. doi: 10.3945/jn.110.135087. Epub 2011 May 18.

    PMID: 21593349DERIVED

MeSH Terms

Conditions

Body WeightHyperlipidemiasInflammation

Interventions

Safflower OilCD2 Antigens

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAntigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkers

Study Officials

  • Peter JH Jones, Ph.D.

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 12, 2010

Study Start

November 1, 2006

Primary Completion

March 1, 2008

Study Completion

May 1, 2009

Last Updated

January 12, 2010

Record last verified: 2009-12