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Food Replacement on Weight Control in Overweight Volunteers

Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06488339
Enrollment
60
Registered
2024-07-05
Start date
2024-07-15
Completion date
2025-05-15
Last updated
2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Gain

Brief 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.

Interventions

DIETARY_SUPPLEMENTProtein and oil supplement

Take 1 sachet/day replaced dinner

Sponsors

Mae Fah Luang University
CollaboratorOTHER
Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Weight8 weeksWeight of volunteers (kg)

Secondary

MeasureTime frameDescription
Percentage of body fat8 weeksPercentage of body fat (%) using bioelectrical impedance analysis (BIA)
Percentage of visceral fat8 weeksPercentage of visceral fat (%) using bioelectrical impedance analysis (BIA)
Percentage of subcutaneous fat8 weeksPercentage of subcutaneous fat (%) using bioelectrical impedance analysis (BIA)
Percentage of muscle8 weeksPercentage of muscle (%) using bioelectrical impedance analysis (BIA)
Waist Circumference8 weeksWaist Circumference (cm)
Hip Circumference8 weeksHip Circumference (cm)
Skin fold thickness8 weeksSkin fold thickness (mm) using Skinfold Caliper
Total cholesterol8 weeksBlood total cholesterol (mg/dL)
Low density lipoprotein8 weeksLow density lipoprotein (mg/dL) in blood
High density lipoprotein8 weeksHigh density lipoprotein (mg/dL) in blood
Triglycerides8 weeksTriglycerides (mg/dL) in blood
Body mass index8 weeksBody mass index of volunteers (kg/m2)
Hemoglobin A1C8 weeksHemoglobin A1C (%) in blood
Total protein8 weeksTotal protein (g/dL) in blood
Hemoglobin8 weeksHemoglobin (g/dL) in blood
SIRT1 (NAD-dependent deacetylase sirtuin-1)8 weeksSIRT1 (NAD-dependent deacetylase sirtuin-1) (%) in blood
8-hydroxy-2-deoxyguanosine8 weeks8-hydroxy-2-deoxyguanosine (%) in blood
Blood urea nitrogen8 weeksBlood urea nitrogen (mg/dL) in blood
Creatinine8 weeksCreatinine (mg/dL) in blood
Aspartate transaminase8 weeksAspartate transaminase (U/L) in blood
Alanine aminotransferase8 weeksAlanine aminotransferase (U/L) in blood
Alkaline phosphatase8 weeksAlkaline phosphatase (U/L) in blood
Fasting blood sugar8 weeksFasting blood sugar (mg/dL) in blood

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026