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Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks (CLAPSProject)

Primary Purpose

Overweight and Obesity, Body Weight

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
CLA-fortified milk powder
Placebo
Nutrition Counseling
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity focused on measuring conjugated linoleic acid, body fat mass, body composition, nutrition counseling

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Body mass index (BMI) 23 - 24.9 kg/m2 for overweight and ≥ 25 kg/m2 for obese
  2. Fat mass percentage (FM%) of ≥ 20% for men and ≥ 30% for women
  3. Agree to follow the study

Exclusion Criteria:

  1. Lactose intolerance
  2. Undergoing treatment (e.g., antibiotics and/or anti-inflammatory or immunosuppressant drugs and weight loss)
  3. Any physical condition that might be contraindicated to dietary restrictions
  4. Any non-communicable disease (e.g., Diabetes Mellitus, Chronic Kidney Disease, Cancer, Hypertension)
  5. Pregnant

Sites / Locations

  • Faculty of Medicine Universitas IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CLA-fortified milk powder

Placebo

Arm Description

Respondents will receive CLA-fortified milk powder containing 3.4 gram for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.

Respondents will receive a placebo milk powder for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.

Outcomes

Primary Outcome Measures

Change of body weight
to investigate the change of body weight before, during and after intervention. Using Seca® type 876 is calibrated scale to the nearest 0.1 kilogram. The lower body weight indicates better outcome
Change of body fat mass
to investigate the change of body fat mass before and after intervention. Using Dual-energy X-ray absorptiometry (DXA GE Lunar® Prodigy 64179). The lower body fat mass indicates better outcome
Change of body fat mass
to investigate the change of body fat mass before, during, and after intervention. Using Bod Pod (Cosmed®). The lower body fat mass indicates better outcome

Secondary Outcome Measures

Change of Waist hip ratio
to investigate the change of waist hip ratio before, during, and after intervention. Waist hip ratio is obtained by dividing the waist circumference and hip circumference. Tape measurement (Seca® type 201) is calibrated scale to nearest 0.1 centimeter. The lower body fat mass indicates better outcome
Change of Low Density Lipoprotein (LDL)
to investigate the change of low density lipoprotein (LDL) in miligram per deciliter before and after intervention. The lower change of LDL indicates the better outcome. Enzymatic method
Change of High Density Lipoprotein (HDL)
to investigate the change of high density lipoprotein (HDL) in miligram per deciliter before and after intervention. The higher change of HDL indicates the better outcome. Enzymatic method
Change of Total of Cholesterol
to investigate the change of total of cholesterol in miligram per deciliter before and after intervention. The lower change of total of cholesterol indicates the better outcome. Enzymatic method
Change of Triglyceride
to investigate the change of triglyceride in miligram per deciliter before and after intervention. The lower change of triglyceride indicates the better outcome. Enzymatic method
Dietary intake (semi quantitative food frequency questionnaire)
to investigate the dietary intake before, during, and after intervention using semi quantitative food frequency questionnaire. The higher number of dietary intake indicates the better outcome
Dietary intake (24-hours recall)
to investigate the dietary intake before, during, and after intervention using 24-hours recall. The higher dietary intake indicates the better outcome
Change of knowledge
to investigate the score of knowledge before and after the intervention. Using validated questionnaire of knowledge. Minimum score is 0 and maximum score is 100.The higher score of knowledge after intervention indicates the better outcome.
Change of attitude
to investigate the score of attitude before and after the intervention. Using validated questionnaire of attitude. Minimum score is 0, maximum score is 100. The higher score of attitude after intervention indicates the better outcome.
Physical activity level
to investigate the physical activity level before, during and after intervention. Using International Physical Activity Questionnaire. The category of physical activity level are low (<600 metabolic equivalents), moderate (>=600 - 3000 metabolic equivalents) and high (>=3000 metabolic equivalents).

Full Information

First Posted
August 11, 2020
Last Updated
August 16, 2021
Sponsor
Indonesia University
Collaborators
BASF
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1. Study Identification

Unique Protocol Identification Number
NCT04531137
Brief Title
Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks
Acronym
CLAPSProject
Official Title
Conjugated Linoleic Acid Combined With Nutrition Counseling Consequences on Body Weight and Body Fat Mass in Overweight and Obese Adult
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
BASF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study has purpose to assess the effect of conjugated linoleic acid (CLA)-fortified milk powder with nutrition counseling and nutrition module in body weight and body fat mass among overweight and obese adult in Indonesia
Detailed Description
After being informed of the potential benefits and risks regarding the study, the respondents were asked to sign the consent. The respondents who met the criteria of overweight/ obese without any historical diseases will be randomized into intervention or placebo groups. The intervention will be given for 12 weeks (CLA-fortified milk powder 3.4 gram, once-daily consumption). Both the intervention and placebo groups will also receive nutrition counseling and nutrition module.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Body Weight
Keywords
conjugated linoleic acid, body fat mass, body composition, nutrition counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study consists of intervention and control groups. The intervention group will receive CLA-fortified milk powder containing 3.4 gram CLA for one a day. The control group will receive milk powder for one a day. In each group, the intervention phase will be conducted in 12 weeks. Each group will also receive nutritional counseling and nutrition module
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLA-fortified milk powder
Arm Type
Experimental
Arm Description
Respondents will receive CLA-fortified milk powder containing 3.4 gram for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.
Arm Title
Placebo
Arm Type
Other
Arm Description
Respondents will receive a placebo milk powder for one a day for 12 weeks. They will also receive individualized nutrition counseling and nutrition module at weeks 0, 4, and 8.
Intervention Type
Dietary Supplement
Intervention Name(s)
CLA-fortified milk powder
Intervention Description
3.4 gram of CLA-fortified milk powder one a day for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo milk powder one a day for 12 weeks
Intervention Type
Other
Intervention Name(s)
Nutrition Counseling
Intervention Description
Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session
Primary Outcome Measure Information:
Title
Change of body weight
Description
to investigate the change of body weight before, during and after intervention. Using Seca® type 876 is calibrated scale to the nearest 0.1 kilogram. The lower body weight indicates better outcome
Time Frame
Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Title
Change of body fat mass
Description
to investigate the change of body fat mass before and after intervention. Using Dual-energy X-ray absorptiometry (DXA GE Lunar® Prodigy 64179). The lower body fat mass indicates better outcome
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Change of body fat mass
Description
to investigate the change of body fat mass before, during, and after intervention. Using Bod Pod (Cosmed®). The lower body fat mass indicates better outcome
Time Frame
Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Secondary Outcome Measure Information:
Title
Change of Waist hip ratio
Description
to investigate the change of waist hip ratio before, during, and after intervention. Waist hip ratio is obtained by dividing the waist circumference and hip circumference. Tape measurement (Seca® type 201) is calibrated scale to nearest 0.1 centimeter. The lower body fat mass indicates better outcome
Time Frame
Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Title
Change of Low Density Lipoprotein (LDL)
Description
to investigate the change of low density lipoprotein (LDL) in miligram per deciliter before and after intervention. The lower change of LDL indicates the better outcome. Enzymatic method
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Change of High Density Lipoprotein (HDL)
Description
to investigate the change of high density lipoprotein (HDL) in miligram per deciliter before and after intervention. The higher change of HDL indicates the better outcome. Enzymatic method
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Change of Total of Cholesterol
Description
to investigate the change of total of cholesterol in miligram per deciliter before and after intervention. The lower change of total of cholesterol indicates the better outcome. Enzymatic method
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Change of Triglyceride
Description
to investigate the change of triglyceride in miligram per deciliter before and after intervention. The lower change of triglyceride indicates the better outcome. Enzymatic method
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Dietary intake (semi quantitative food frequency questionnaire)
Description
to investigate the dietary intake before, during, and after intervention using semi quantitative food frequency questionnaire. The higher number of dietary intake indicates the better outcome
Time Frame
Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
Title
Dietary intake (24-hours recall)
Description
to investigate the dietary intake before, during, and after intervention using 24-hours recall. The higher dietary intake indicates the better outcome
Time Frame
Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
Title
Change of knowledge
Description
to investigate the score of knowledge before and after the intervention. Using validated questionnaire of knowledge. Minimum score is 0 and maximum score is 100.The higher score of knowledge after intervention indicates the better outcome.
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Change of attitude
Description
to investigate the score of attitude before and after the intervention. Using validated questionnaire of attitude. Minimum score is 0, maximum score is 100. The higher score of attitude after intervention indicates the better outcome.
Time Frame
Baseline (after signing the consent) week-0 and week-12 (endline)
Title
Physical activity level
Description
to investigate the physical activity level before, during and after intervention. Using International Physical Activity Questionnaire. The category of physical activity level are low (<600 metabolic equivalents), moderate (>=600 - 3000 metabolic equivalents) and high (>=3000 metabolic equivalents).
Time Frame
Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) 23 - 24.9 kg/m2 for overweight and ≥ 25 kg/m2 for obese Fat mass percentage (FM%) of ≥ 20% for men and ≥ 30% for women Agree to follow the study Exclusion Criteria: Lactose intolerance Undergoing treatment (e.g., antibiotics and/or anti-inflammatory or immunosuppressant drugs and weight loss) Any physical condition that might be contraindicated to dietary restrictions Any non-communicable disease (e.g., Diabetes Mellitus, Chronic Kidney Disease, Cancer, Hypertension) Pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fiastuti Witjaksono, Doctoral
Phone
+62816889 941
Email
fiastuti_dr@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Erfi Prafiantini
Phone
+628179273389
Email
prafiantini@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiastuti Witjaksono, Doctoral
Organizational Affiliation
Department of Nutrition, Faculty of Medicine of Universitas Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Universitas Indonesia
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiastuti Witjaksono, Doctoral
Phone
+62816889 941
Email
fiastuti_dr@yahoo.com
First Name & Middle Initial & Last Name & Degree
Erfi Prafiantini, Master
Phone
+628179273389
Email
prafiantini@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks

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