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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conjugated Linoleic Acid Combined With Nutrition Counseling Consequences on Body Weight and Body Fat Mass in Overweight and Obese Adult

Conditions
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Overweight and Obesity, Body Weight

Intervention / Treatment
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* Dietary Supplement: CLA-fortified milk powder
* Other: Placebo
* Other: Nutrition Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLA-fortified milk powder<br>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. | Dietary Supplement: CLA-fortified milk powder<br>* 3.4 gram of CLA-fortified milk powder one a day for 12 weeks<br>Other: Nutrition Counseling<br>* Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session<br>|
| Other: Placebo<br>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. | Other: Placebo<br>* Placebo milk powder one a day for 12 weeks<br>Other: Nutrition Counseling<br>* Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0, week-8 and week-12 (endline) | 
| 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 | Baseline (after signing the consent) week-0, week-8 and week-12 (endline) | 
| 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. | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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. | Baseline (after signing the consent) week-0 and week-12 (endline) | 
| 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). | Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conjugated linoleic acid, body fat mass, body composition, nutrition counseling