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

Overweight and Obesity Clinical Trial

— CLAPSProject  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531137
• Other study ID #: 19-10-1189
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: November 2021

Study information

• Verified date: August 2021
• Source: Indonesia University
• Contact: Fiastuti Witjaksono, Doctoral
• Phone: +62816889 941
• Email: fiastuti_dr[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• CLA-fortified milk powder
3.4 gram of CLA-fortified milk powder one a day for 12 weeks

Other:
• Placebo
Placebo milk powder one a day for 12 weeks
• Nutrition Counseling
Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine Universitas Indonesia	Jakarta Pusat	Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	BASF

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)