Clinical trial NCT04531137: Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks
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
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Body Weight
Keywords: conjugated linoleic acid
body fat mass
body composition
nutrition counseling
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: BASF
First posted: 2020-08-28
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of body weight
timeFrame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
measure: Change of body fat mass
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Change of body fat mass
timeFrame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Secondary outcomes:
measure: Change of Waist hip ratio
timeFrame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
measure: Change of Low Density Lipoprotein (LDL)
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Change of High Density Lipoprotein (HDL)
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Change of Total of Cholesterol
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Change of Triglyceride
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Dietary intake (semi quantitative food frequency questionnaire)
timeFrame: Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
measure: Dietary intake (24-hours recall)
timeFrame: Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
measure: Change of knowledge
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Change of attitude
timeFrame: Baseline (after signing the consent) week-0 and week-12 (endline)
measure: Physical activity level
timeFrame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine Universitas Indonesia
state: Jakarta
Study officials:
affiliation: Department of Nutrition, Faculty of Medicine of Universitas Indonesia
name: Fiastuti Witjaksono, Doctoral
role: PRINCIPAL_INVESTIGATOR
References: