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

University of Indonesia (UI)

Status: Unknown

Conditions: Overweight and Obesity; Body Weight

Treatments: Other: Placebo; Dietary Supplement: CLA-fortified milk powder; Other: Nutrition Counseling

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04531137

19-10-1189

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

CLA-fortified milk powder

Experimental group

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.

Treatment:

Other: Nutrition Counseling

Dietary Supplement: CLA-fortified milk powder

Placebo

Other group

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.

Treatment:

Other: Placebo

Other: Nutrition Counseling