Food Replacement on Weight Control in Overweight Volunteers

Not Applicable

Not yet recruiting

• Conditions: Weight Gain
• Interventions: Dietary Supplement: Protein and oil supplement

• Registration Number: NCT06488339
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-05
• Last Update Posted: 2024-07-05
• Study Start: 2024-07-15
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein and oil supplement	Protein and oil supplement	Take 1 sachet/day replaced dinner

Primary Outcome Measures

Name	Time	Method
Weight	8 weeks	Weight of volunteers (kg)

Secondary Outcome Measures

Name	Time	Method
Body mass index	8 weeks	Body mass index of volunteers (kg/m2)
Percentage of body fat	8 weeks	Percentage of body fat (%) using bioelectrical impedance analysis (BIA)
Hemoglobin A1C	8 weeks	Hemoglobin A1C (%) in blood
Total protein	8 weeks	Total protein (g/dL) in blood
Percentage of visceral fat	8 weeks	Percentage of visceral fat (%) using bioelectrical impedance analysis (BIA)
Percentage of subcutaneous fat	8 weeks	Percentage of subcutaneous fat (%) using bioelectrical impedance analysis (BIA)
Percentage of muscle	8 weeks	Percentage of muscle (%) using bioelectrical impedance analysis (BIA)
Hip Circumference	8 weeks	Hip Circumference (cm)
Total cholesterol	8 weeks	Blood total cholesterol (mg/dL)
Waist Circumference	8 weeks	Waist Circumference (cm)
Skin fold thickness	8 weeks	Skin fold thickness (mm) using Skinfold Caliper
Low density lipoprotein	8 weeks	Low density lipoprotein (mg/dL) in blood
Triglycerides	8 weeks	Triglycerides (mg/dL) in blood
8-hydroxy-2-deoxyguanosine	8 weeks	8-hydroxy-2-deoxyguanosine (%) in blood
High density lipoprotein	8 weeks	High density lipoprotein (mg/dL) in blood
Fasting blood sugar	8 weeks	Fasting blood sugar (mg/dL) in blood
Hemoglobin	8 weeks	Hemoglobin (g/dL) in blood
SIRT1 (NAD-dependent deacetylase sirtuin-1)	8 weeks	SIRT1 (NAD-dependent deacetylase sirtuin-1) (%) in blood
Blood urea nitrogen	8 weeks	Blood urea nitrogen (mg/dL) in blood
Alanine aminotransferase	8 weeks	Alanine aminotransferase (U/L) in blood
Creatinine	8 weeks	Creatinine (mg/dL) in blood
Aspartate transaminase	8 weeks	Aspartate transaminase (U/L) in blood
Alkaline phosphatase	8 weeks	Alkaline phosphatase (U/L) in blood