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

NCT04531137 | Unknown DMC

• 1 other identifier: 19-10-1189
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Conditions

Overweight and Obesity; Body Weight

Keywords

conjugated linoleic acid; body fat mass; body composition; nutrition counseling

Outcome Measures

Primary Outcomes (3)

• Change 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

  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

  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

  Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)

Secondary Outcomes (10)

• Change of Waist hip ratio

  Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)

• Change of Low Density Lipoprotein (LDL)

  Baseline (after signing the consent) week-0 and week-12 (endline)

• Change of High Density Lipoprotein (HDL)

  Baseline (after signing the consent) week-0 and week-12 (endline)

• Change of Total of Cholesterol

  Baseline (after signing the consent) week-0 and week-12 (endline)

• Change of Triglyceride

  Baseline (after signing the consent) week-0 and week-12 (endline)

Study Arms (2)

CLA-fortified milk powder

EXPERIMENTAL

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.

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

Placebo

OTHER

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.

Other: Placebo; Other: Nutrition Counseling

Interventions

CLA-fortified milk powder DIETARY_SUPPLEMENT

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

CLA-fortified milk powder

Placebo OTHER

Placebo milk powder one a day for 12 weeks

Placebo

Nutrition Counseling OTHER

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

CLA-fortified milk powder; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• BASF: collaborator

Study Sites (1)

Faculty of Medicine Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Body Weight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fiastuti Witjaksono, Doctoral

  Department of Nutrition, Faculty of Medicine of Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiastuti Witjaksono, Doctoral

CONTACT

+62816889 941; fiastuti_dr@yahoo.com

Erfi Prafiantini

CONTACT

+628179273389; prafiantini@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 28, 2020
• Study Start: August 5, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)