ClinicalTrials.gg
Not yet recruitingNCT06488339Updated Jul 5, 2024

Food Replacement on Weight Control in Overweight Volunteers

An interventional study of Protein and oil supplement in Weight Gain, sponsored by Chulalongkorn University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Chulalongkorn University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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. Weight, body mass index, body composition, waist and hip circumference, skin fold thickness, and chemistry in blood will be evaluated.

02

Conditions studied

  • Weight Gain

Browse trials for

03

In context

Weight Gain

317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.

This study's planned enrollment of 60 is below the median of 83 across 251 interventional studies indexed under Weight Gain.

Browse Weight Gain studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-60 years
  • more than 23 kg/m2
  • No heart disease, diabetes mellitus, thyroid disease, cancer, liver and kidney diseases
  • Wiling to attend the study

Exclusion criteria

Exclusion Criteria:

  • Allergic to protein, grains, guar gum
  • Take medicine, supplement, herbal substance for weight control within 1 month
  • During intermittent fasting
  • Take pill, , anti-depressant drugs, and anti-epilepsy drugs
  • Cushing syndrome's
  • Pregnancy and lactation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Protein and oil supplement

    Take 1 sachet/day replaced dinner

    Dietary Supplement: Protein and oil supplement

  • No intervention
    Normal dietary meal

    Take normal dietary meal for dinner

Interventions

  • Dietary supplementProtein and oil supplement

    Take 1 sachet/day replaced dinner

06

What researchers measure

Primary outcomes

  1. Weight

    Weight of volunteers (kg)

    Time frame: 8 weeks

Secondary outcomes

  1. Body mass index

    Body mass index of volunteers (kg/m2)

    Time frame: 8 weeks

  2. Percentage of body fat

    Percentage of body fat (%) using bioelectrical impedance analysis (BIA)

    Time frame: 8 weeks

  3. Percentage of visceral fat

    Percentage of visceral fat (%) using bioelectrical impedance analysis (BIA)

    Time frame: 8 weeks

  4. Percentage of subcutaneous fat

    Percentage of subcutaneous fat (%) using bioelectrical impedance analysis (BIA)

    Time frame: 8 weeks

  5. Percentage of muscle

    Percentage of muscle (%) using bioelectrical impedance analysis (BIA)

    Time frame: 8 weeks

  6. Waist Circumference

    Waist Circumference (cm)

    Time frame: 8 weeks

  7. Hip Circumference

    Hip Circumference (cm)

    Time frame: 8 weeks

  8. Skin fold thickness

    Skin fold thickness (mm) using Skinfold Caliper

    Time frame: 8 weeks

  9. Total cholesterol

    Blood total cholesterol (mg/dL)

    Time frame: 8 weeks

  10. Low density lipoprotein

    Low density lipoprotein (mg/dL) in blood

    Time frame: 8 weeks

  11. High density lipoprotein

    High density lipoprotein (mg/dL) in blood

    Time frame: 8 weeks

  12. Triglycerides

    Triglycerides (mg/dL) in blood

    Time frame: 8 weeks

  13. Fasting blood sugar

    Fasting blood sugar (mg/dL) in blood

    Time frame: 8 weeks

  14. Hemoglobin A1C

    Hemoglobin A1C (%) in blood

    Time frame: 8 weeks

  15. Total protein

    Total protein (g/dL) in blood

    Time frame: 8 weeks

  16. Hemoglobin

    Hemoglobin (g/dL) in blood

    Time frame: 8 weeks

  17. SIRT1 (NAD-dependent deacetylase sirtuin-1)

    SIRT1 (NAD-dependent deacetylase sirtuin-1) (%) in blood

    Time frame: 8 weeks

  18. 8-hydroxy-2-deoxyguanosine

    8-hydroxy-2-deoxyguanosine (%) in blood

    Time frame: 8 weeks

  19. Blood urea nitrogen

    Blood urea nitrogen (mg/dL) in blood

    Time frame: 8 weeks

  20. Creatinine

    Creatinine (mg/dL) in blood

    Time frame: 8 weeks

  21. Aspartate transaminase

    Aspartate transaminase (U/L) in blood

    Time frame: 8 weeks

  22. Alanine aminotransferase

    Alanine aminotransferase (U/L) in blood

    Time frame: 8 weeks

  23. Alkaline phosphatase

    Alkaline phosphatase (U/L) in blood

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06488339
Collaborators
Mae Fah Luang University
Responsible party
Pornanong Aramwit, Pharm.D., Ph.D (Professor, Chulalongkorn University) — Principal investigator
First posted
Jul 5, 2024
Start date
Jul 15, 2024 (estimated)
Primary completion
Apr 30, 2025 (estimated)
Completion
May 15, 2025 (estimated)
Last update
Jul 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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