Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks
- Conditions
- Overweight and ObesityBody Weight
- Interventions
- Other: PlaceboDietary Supplement: CLA-fortified milk powderOther: Nutrition Counseling
- Registration Number
- NCT04531137
- Lead Sponsor
- Indonesia University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Nutrition Counseling 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. Placebo Placebo 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. CLA-fortified milk powder CLA-fortified milk powder 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. CLA-fortified milk powder Nutrition Counseling 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.
- Primary Outcome Measures
Name Time Method Change of body weight Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) 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 Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) 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
Name Time Method Change of Waist hip ratio Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) 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) Baseline (after signing the consent) week-0 and week-12 (endline) 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) Baseline (after signing the consent) week-0 and week-12 (endline) 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 Baseline (after signing the consent) week-0 and week-12 (endline) 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 Baseline (after signing the consent) week-0 and week-12 (endline) 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) Baseline (after signing the consent) week-0, week-8 and week-12 (endline) 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) Baseline (after signing the consent) week-0, week-8 and week-12 (endline) to investigate the dietary intake before, during, and after intervention using 24-hours recall. The higher dietary intake indicates the better outcome
Physical activity level Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline) 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).
Change of knowledge Baseline (after signing the consent) week-0 and week-12 (endline) 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 Baseline (after signing the consent) week-0 and week-12 (endline) 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.
Trial Locations
- Locations (1)
Faculty of Medicine Universitas Indonesia
🇮🇩Jakarta Pusat, Jakarta, Indonesia