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

Conjugated Linoleic Acid Combined With Nutrition Counseling Consequences on Body Weight and Body Fat Mass in Overweight and Obese Adult

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

Study Overview

• Status: Recruiting
• Conditions: Body Weight; Overweight and Obesity
• Intervention / Treatment: Dietary supplement: CLA-fortified milk powder; Other: Nutrition Counseling; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiastuti Witjaksono, Doctoral; Phone Number: +62816889 941; Email: fiastuti_dr@yahoo.com
• Study Contact Backup: Name: Erfi Prafiantini; Phone Number: +628179273389; Email: prafiantini@gmail.com

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Recruiting
      • Faculty of Medicine Universitas Indonesia
      • Contact: Fiastuti Witjaksono, Doctoral; Phone Number: +62816889 941; Email: fiastuti_dr@yahoo.com
      • Contact: Erfi Prafiantini, Master; Phone Number: +628179273389; Email: prafiantini@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: CLA-fortified milk powder; 3.4 gram of CLA-fortified milk powder one a day for 12 weeks; Other: Nutrition Counseling; Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session
Other: 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.	Other: Nutrition Counseling; Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session; Other: Placebo; Placebo milk powder one a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Waist hip ratio	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	Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Change of Low Density Lipoprotein (LDL)	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	Baseline (after signing the consent) week-0 and week-12 (endline)
Change of High Density Lipoprotein (HDL)	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	Baseline (after signing the consent) week-0 and week-12 (endline)
Change of Total of Cholesterol	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	Baseline (after signing the consent) week-0 and week-12 (endline)
Change of Triglyceride	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	Baseline (after signing the consent) week-0 and week-12 (endline)
Dietary intake (semi quantitative food frequency questionnaire)	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	Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
Dietary intake (24-hours recall)	to investigate the dietary intake before, during, and after intervention using 24-hours recall. The higher dietary intake indicates the better outcome	Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
Change of knowledge	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.	Baseline (after signing the consent) week-0 and week-12 (endline)
Change of attitude	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.	Baseline (after signing the consent) week-0 and week-12 (endline)
Physical activity level	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).	Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: BASF
• Investigators: Principal Investigator: Fiastuti Witjaksono, Doctoral, Department of Nutrition, Faculty of Medicine of Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: body composition; conjugated linoleic acid; body fat mass; nutrition counseling
• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: 19-10-1189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No