UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020284
Receipt No. R000023408
Scientific Title Effects of Conjugated Linoleic Acid and Exercise on Body Fat Mass and Lipid Profiles Among Overweight Iranians After Weight Loss
Date of disclosure of the study information 2015/12/21
Last modified on 2015/12/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of Conjugated Linoleic Acid and Exercise on Body Fat Mass and Lipid Profiles Among Overweight Iranians After Weight Loss
Acronym Effects of Conjugated Linoleic Acid and Exercise on Body Fat Mass and Lipid Profiles Among Overweight Iranians After Weight Loss
Scientific Title Effects of Conjugated Linoleic Acid and Exercise on Body Fat Mass and Lipid Profiles Among Overweight Iranians After Weight Loss
Scientific Title:Acronym Effects of Conjugated Linoleic Acid and Exercise on Body Fat Mass and Lipid Profiles Among Overweight Iranians After Weight Loss
Region
Asia(except Japan)

Condition
Condition Diet and Nutrition
Weight Loss
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Assess the Effects of Conjugated Linoleic Acid and Exercise on Body Fat Mass of Overweight Iranians
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Significant Change in Body Fat Mass
(Baseline, and at 6 and 12 weeks after intervention commencement)
Key secondary outcomes Significant Change in Lipid Profiles
(Baseline, and at 6 and 12 weeks after intervention commencement)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food Other
Interventions/Control_1 Control Group:
- Weight Loss Diet and No Supplementation or Exercise
Interventions/Control_2 Intervention Group 1 (CLA Supplementation):
- Weight Loss Diet
- Mixture of the two bioactive isomers in the form of a 1500 mg softgel -50% cis-9, trans-11 and 50% trans-10, cis-12- twice a day for 12 weeks
Interventions/Control_3 Intervention Group 2 (CLA Supplementation + Exercise):
- Weight Loss Diet
- Mixture of the two bioactive isomers in the form of a 1500 mg softgel -50% cis-9, trans-11 and 50% trans-10, cis-12- twice a day for 12 weeks
- Exercise as walking with the speed of 5.5-6 km/h for at least 160 minutes per week which the subjects had the choice to spare it into three or four times a week. Subjects kept track of walking speed and distance using treadmill or software installed on their cellphone, and recorded their exercise activity and provided it to the dietitian at each visit
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria Healthy overweight Iranian volunteers who used to be obese, aged between 20-50 years old, and with a BMI ranged between 26-29. These subjects must have a BFM of more than 28% for women and 21% for men, and they were not taking any medication or supplement
Key exclusion criteria Pregnancy, nursing, history of hospitalization, or any former or current health related condition considered as the exclusion criteria.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Loh Su Peng
Organization University Putra Malaysia
Division name Dept of Nutrition and Dietetics, Faculty of Medicine and Health Sciences
Zip code
Address University Putra Malaysia, 43400, Serdang, Selangor
TEL +60-389472432
Email sploh@upm.edu.my

Public contact
Name of contact person
1st name
Middle name
Last name Loh Su Peng
Organization University Putra Malaysia
Division name Dept of Nutrition and Dietetics, Faculty of Medicine and Health Sciences
Zip code
Address University Putra Malaysia, 43400, Serdang, Selangor
TEL +60-389472432
Homepage URL
Email sploh@upm.edu.my

Sponsor
Institute University Puta Malaysia
Institute
Department

Funding Source
Organization Private Organization - TR Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Iran

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 U1111-1177-8528
Org. issuing International ID_1 WHO UTN
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 3 Health Clinics (Tehran, Iran)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
171 subjects completed their participation (Response Rate = 95%), and in comparison with the baseline body weight, Body Mass Index (BMI), Body Fat Mass (BFM), and waist to hip ratio of the CLA and CLA+E groups had a significant decrease (P < 0.05) with average BFM loss being 10.3% and 12% among CLA and CLA+E, respectively, compared to 2.7% among Control group. As for the biochemical analysis, the blood free fatty acid increased and high density lipoprotein decreased in CLA group which was an unfavorable effect of CLA supplementation. Although the supplementation alone appeared to have some non-desirable effects on the mentioned blood tests, this change did not occur among the exercise group.

As a conclusion, supplementation with conjugated linoleic acid among overweight Iranians for 12 weeks reduced the BFM with some adverse effects on blood profiles which can be controlled through a moderate-intense exercise.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2013 Year 12 Month 20 Day
Date analysis concluded
2014 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 20 Day
Last modified on
2015 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023408

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.