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

NCT ID: NCT04531137

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2021-11-30

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.

Conditions

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Overweight and Obesity Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CLA-fortified milk powder

Intervention Type DIETARY_SUPPLEMENT

3.4 gram of CLA-fortified milk powder one a day for 12 weeks

Nutrition Counseling

Intervention Type OTHER

Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session

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.

Group Type OTHER

Placebo

Intervention Type OTHER

Placebo milk powder one a day for 12 weeks

Nutrition Counseling

Intervention Type OTHER

Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session

Interventions

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CLA-fortified milk powder

3.4 gram of CLA-fortified milk powder one a day for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo milk powder one a day for 12 weeks

Intervention Type OTHER

Nutrition Counseling

Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BASF

INDUSTRY

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Fiastuti Witjaksono

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fiastuti Witjaksono, Doctoral

Role: PRINCIPAL_INVESTIGATOR

Department of Nutrition, Faculty of Medicine of Universitas Indonesia

Locations

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Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Fiastuti Witjaksono, Doctoral

Role: CONTACT

+62816889 941

Erfi Prafiantini

Role: CONTACT

+628179273389

Facility Contacts

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Fiastuti Witjaksono, Doctoral

Role: primary

+62816889 941

Erfi Prafiantini, Master

Role: backup

+628179273389

Other Identifiers

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19-10-1189

Identifier Type: -

Identifier Source: org_study_id

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