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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
84
3.4 gram of CLA-fortified milk powder one a day for 12 weeks
Placebo milk powder one a day for 12 weeks
Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session
Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
RECRUITINGChange 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
Time frame: 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
Time frame: 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
Time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
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
Time frame: 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
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Change of High Density Lipoprotein (HDL)
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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)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)