Overweight and ObesityCLAPSProjectNCT04531137
Conjugated Linoleic Acid on Body Weight and Body Fat Mass for 12 Weeks
A study testing CLA-fortified milk powder and Nutrition Counseling in people with Overweight and Obesity and Body Weight, run by Universitas Indonesia at 1 site in Indonesia.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Overweight and Obesity, Body Weight
- What is being tested?
- CLA-fortified milk powder and Nutrition Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIndonesia
- Study dates
- 5 Aug 2020to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
Fiastuti Witjaksono, Doctoral, +62816889 941, fiastuti_dr@yahoo.com
Erfi Prafiantini, Master, +628179273389, prafiantini@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Overweight and Obesity, Body Weight
- Being tested
- CLA-fortified milk powder, Placebo, Nutrition Counseling
- Keywords
- conjugated linoleic acid, body fat mass, body composition, nutrition counseling
- Medical subject headings
- Overweight, Obesity, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLA-fortified milk powderDietary supplement
3.4 gram of CLA-fortified milk powder one a day for 12 weeks
PlaceboOther
Placebo milk powder one a day for 12 weeks
Nutrition CounselingOther
Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo; Other: Nutrition Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start5 Aug 2020
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- BASF
- Responsible party
- Principal investigator, Fiastuti Witjaksono, Universitas Indonesia
- Investigators
- Fiastuti Witjaksono, Doctoral, Principal investigator, Department of Nutrition, Faculty of Medicine of Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531137
- Sponsor's protocol ID
- 19-10-1189
- Acronym
- CLAPSProject
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conjugated Linoleic Acid Combined With Nutrition Counseling Consequences on Body Weight and Body Fat Mass in Overweight and Obese Adult
- ClinicalTrials.gov ID
- NCT04531137
- Acronym / sponsor ID
- CLAPSProject / 19-10-1189
- Conditions
- Overweight and Obesity, Body Weight
- Keywords
- conjugated linoleic acid, body fat mass, body composition, nutrition counseling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- BASF
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| CLA-fortified milk powder | Experimental | Dietary Supplement: CLA-fortified milk powder, Other: Nutrition CounselingRespondents 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. |
| Placebo | Other | Other: Placebo, Other: Nutrition CounselingRespondents 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLA-fortified milk powder3.4 gram of CLA-fortified milk powder one a day for 12 weeks | Dietary supplement | CLA-fortified milk powder |
| PlaceboPlacebo milk powder one a day for 12 weeks | Other | Placebo |
| Nutrition CounselingIndividualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session | Other | CLA-fortified milk powder, Placebo |
Primary outcome
Change of body weight
Time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
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
Change of body fat mass
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
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
Change of body fat mass
Time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
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
10 secondary outcomes
Change of Waist hip ratio
Time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Change of Low Density Lipoprotein (LDL)
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Change of High Density Lipoprotein (HDL)
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Change of Total of Cholesterol
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Change of Triglyceride
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Dietary intake (semi quantitative food frequency questionnaire)
Time frame: Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
Dietary intake (24-hours recall)
Time frame: Baseline (after signing the consent) week-0, week-8 and week-12 (endline)
Change of knowledge
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Change of attitude
Time frame: Baseline (after signing the consent) week-0 and week-12 (endline)
Physical activity level
Time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiastuti Witjaksono, Doctoral principal investigator
Department of Nutrition, Faculty of Medicine of Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLA-fortified milk powder and Nutrition Counseling in people with Overweight and Obesity and Body Weight, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fiastuti Witjaksono, Doctoral (+62816889 941, fiastuti_dr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body weight (time frame: Baseline (after signing the consent) week-0, week-4, week-8, and week-12 (endline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.