UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020284 |
|---|---|
| Receipt number | 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 13:49:28 |
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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
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
sploh@upm.edu.my
Sponsor or person
Institute
University Puta Malaysia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023408
