Back to Search
Start Over
Safety of Dietary Conjugated Linoleic Acid (CLA) in a 12-weeks Trial in Healthy Overweight Japanese Male Volunteers
- Source :
- Journal of Oleo Science. 56:517-525
- Publication Year :
- 2007
- Publisher :
- Japan Oil Chemists' Society, 2007.
-
Abstract
- A study was conducted to investigate the short-term safety of dietary conjugated linoleic acid (CLA) in overweight Japanese male volunteers. The study design was a randomized, double-blind placebo-controlled trial including 60 healthy overweight volunteers (body mass index (BMI), 25 approximately 35 kg/m(2)). The subjects were randomly assigned to three groups: 5.4 g CLA-triacylglycerol (3.4 g as CLA), 10.8 g CLA-triacylglycerol (6.8 g as CLA) and placebo (10.8 g safflower oil) daily for 12 weeks. The CLA-triaclyglycerol contained 9c,11t- and 10t,12c-isomers at an equal proportion. The safety was evaluated by analyses of blood parameters and by clinical examinations at the baseline, and at 6 and 12 weeks, including vital signs and adverse effects. All subjects completed the study. The occurrence of adverse events tended to be higher in the CLA groups than in the placebo group, but all of the adverse events were mild to moderate, within normal ranges, and temporary. Serum aspartate aminotransferase (AST) activity did not differ significantly between the groups at 12 weeks, but in the high CLA group it was slightly increased from the baseline. Serum alanine aminotransferase (ALT) activity was higher in the high CLA group than in the placebo group after 12 weeks and was higher than at the baseline in both CLA groups. However, statistical analysis of the population of apparently healthy volunteers who had normal blood parameters at the baseline revealed that AST and ALT levels did not differ significantly among the 3 groups at 12 weeks. Moreover, no clinically significant changes in vital signs were observed in any of the groups. These results indicate that CLA at a dose of 3.4 g/day is a safe dietary level in healthy Japanese populations in terms of the parameters examined.
- Subjects :
- Adult
Male
General Chemical Engineering
Conjugated linoleic acid
Population
Physiology
Blood Pressure
Overweight
Placebo
law.invention
Placebos
chemistry.chemical_compound
Japan
Randomized controlled trial
Heart Rate
law
medicine
Humans
Linoleic Acids, Conjugated
Obesity
education
Adverse effect
Exercise
education.field_of_study
integumentary system
business.industry
food and beverages
General Medicine
General Chemistry
Middle Aged
Lipid Metabolism
medicine.disease
Lipids
Liver
Biochemistry
chemistry
Dietary Supplements
lipids (amino acids, peptides, and proteins)
medicine.symptom
business
Body mass index
Subjects
Details
- ISSN :
- 13473352 and 13458957
- Volume :
- 56
- Database :
- OpenAIRE
- Journal :
- Journal of Oleo Science
- Accession number :
- edsair.doi.dedup.....20221e7521bf5487bafca921c851f6cf