Weight GainNCT06488339
Food Replacement on Weight Control in Overweight Volunteers
A study testing Protein and oil supplement in people with Weight Gain, run by Chulalongkorn University.
Trial summary
Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Gain
- What is being tested?
- Protein and oil supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 15 May 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years
- Body mass index more than 23 kg/m2
- No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
- Wiling to attend the study
Who cannot join
- Allergic to protein, grains, guar gum
- Take medicine, supplement, herbal substance for weight control within 1 month
- During intermittent fasting
- Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs
- Cushing syndrome's
- Pregnancy and lactation
About this study
Official title: Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers
Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.
- Conditions
- Weight Gain
- Being tested
- Protein and oil supplement
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein and oil supplementDietary supplement
Take 1 sachet/day replaced dinner
| Study group | Role | What they receive |
|---|---|---|
| Protein and oil supplement | Experimental | Take 1 sachet/day replaced dinner Receives: Dietary Supplement: Protein and oil supplement |
| Normal dietary meal | No intervention | Take normal dietary meal for dinner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Weight of volunteers (kg)
Measured: 8 weeks
Secondary outcomes (23)
Body mass index
Body mass index of volunteers (kg/m2)
Measured: 8 weeks
Percentage of body fat
Percentage of body fat (%) using bioelectrical impedance analysis (BIA)
Measured: 8 weeks
Percentage of visceral fat
Percentage of visceral fat (%) using bioelectrical impedance analysis (BIA)
Measured: 8 weeks
Percentage of subcutaneous fat
Percentage of subcutaneous fat (%) using bioelectrical impedance analysis (BIA)
Measured: 8 weeks
Percentage of muscle
Percentage of muscle (%) using bioelectrical impedance analysis (BIA)
Measured: 8 weeks
Waist Circumference
Waist Circumference (cm)
Measured: 8 weeks
Hip Circumference
Hip Circumference (cm)
Measured: 8 weeks
Skin fold thickness
Skin fold thickness (mm) using Skinfold Caliper
Measured: 8 weeks
Total cholesterol
Blood total cholesterol (mg/dL)
Measured: 8 weeks
Low density lipoprotein
Low density lipoprotein (mg/dL) in blood
Measured: 8 weeks
High density lipoprotein
High density lipoprotein (mg/dL) in blood
Measured: 8 weeks
Triglycerides
Triglycerides (mg/dL) in blood
Measured: 8 weeks
Fasting blood sugar
Fasting blood sugar (mg/dL) in blood
Measured: 8 weeks
Hemoglobin A1C
Hemoglobin A1C (%) in blood
Measured: 8 weeks
Total protein
Total protein (g/dL) in blood
Measured: 8 weeks
Hemoglobin
Hemoglobin (g/dL) in blood
Measured: 8 weeks
SIRT1 (NAD-dependent deacetylase sirtuin-1)
SIRT1 (NAD-dependent deacetylase sirtuin-1) (%) in blood
Measured: 8 weeks
8-hydroxy-2-deoxyguanosine
8-hydroxy-2-deoxyguanosine (%) in blood
Measured: 8 weeks
Blood urea nitrogen
Blood urea nitrogen (mg/dL) in blood
Measured: 8 weeks
Creatinine
Creatinine (mg/dL) in blood
Measured: 8 weeks
Aspartate transaminase
Aspartate transaminase (U/L) in blood
Measured: 8 weeks
Alanine aminotransferase
Alanine aminotransferase (U/L) in blood
Measured: 8 weeks
Alkaline phosphatase
Alkaline phosphatase (U/L) in blood
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Mae Fah Luang University
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488339
- Sponsor's protocol ID
- EC23238-20
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers
- ClinicalTrials.gov ID
- NCT06488339
- Acronym / sponsor ID
- EC23238-20
- Conditions
- Weight Gain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Mae Fah Luang University
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
Volunteers will be divided into two groups which are protein and oil supplement group and normal dietary group. For protein and oil supplement group, they will take 1 sachet of product replaced dinner every day for 8 weeks. For normal dietary group, they will take regular dinner every day for 8 weeks. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protein and oil supplement | Experimental | Dietary Supplement: Protein and oil supplementTake 1 sachet/day replaced dinner |
| Normal dietary meal | No intervention | –Take normal dietary meal for dinner |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years
- Body mass index more than 23 kg/m2
- No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
- Wiling to attend the study
Key exclusion criteria (6 listed)
- Allergic to protein, grains, guar gum
- Take medicine, supplement, herbal substance for weight control within 1 month
- During intermittent fasting
- Take birth control pill, steroids, anti-depressant drugs, and anti-epilepsy drugs
- Cushing syndrome's
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 |
|---|---|---|
| Protein and oil supplementTake 1 sachet/day replaced dinner | Dietary supplement | Protein and oil supplement |
Primary outcome
Weight
Time frame: 8 weeks
Weight of volunteers (kg)
23 secondary outcomes
Body mass index
Time frame: 8 weeks
Percentage of body fat
Time frame: 8 weeks
Percentage of visceral fat
Time frame: 8 weeks
Percentage of subcutaneous fat
Time frame: 8 weeks
Percentage of muscle
Time frame: 8 weeks
Waist Circumference
Time frame: 8 weeks
Hip Circumference
Time frame: 8 weeks
Skin fold thickness
Time frame: 8 weeks
Total cholesterol
Time frame: 8 weeks
Low density lipoprotein
Time frame: 8 weeks
High density lipoprotein
Time frame: 8 weeks
Triglycerides
Time frame: 8 weeks
Fasting blood sugar
Time frame: 8 weeks
Hemoglobin A1C
Time frame: 8 weeks
Total protein
Time frame: 8 weeks
Hemoglobin
Time frame: 8 weeks
SIRT1 (NAD-dependent deacetylase sirtuin-1)
Time frame: 8 weeks
8-hydroxy-2-deoxyguanosine
Time frame: 8 weeks
Blood urea nitrogen
Time frame: 8 weeks
Creatinine
Time frame: 8 weeks
Aspartate transaminase
Time frame: 8 weeks
Alanine aminotransferase
Time frame: 8 weeks
Alkaline phosphatase
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Protein and oil supplement in people with Weight Gain, run by Chulalongkorn University.
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 4 inclusion and 6 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: 8 weeks). 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 5 Jul 2024.