NCT06488339Not yet recruitingNot Applicable
Efficacy and Safety of Food Replacement on Weight Control in Overweight Volunteers
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Chulalongkorn University
- Enrollment
- 60
- Primary Endpoint
- Weight
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Protein and oil supplement
Experimental
Take 1 sachet/day replaced dinner
Intervention: Protein and oil supplement (Dietary Supplement)
Normal dietary meal
No Intervention
Take normal dietary meal for dinner
Outcomes
Primary Outcomes
Weight
Time Frame: 8 weeks
Weight of volunteers (kg)
Secondary Outcomes
- Percentage of body fat(8 weeks)
- Body mass index(8 weeks)
- Hemoglobin A1C(8 weeks)
- Total protein(8 weeks)
- Percentage of visceral fat(8 weeks)
- Percentage of subcutaneous fat(8 weeks)
- Percentage of muscle(8 weeks)
- Hip Circumference(8 weeks)
- Total cholesterol(8 weeks)
- Waist Circumference(8 weeks)
- Skin fold thickness(8 weeks)
- Low density lipoprotein(8 weeks)
- Triglycerides(8 weeks)
- 8-hydroxy-2-deoxyguanosine(8 weeks)
- High density lipoprotein(8 weeks)
- Fasting blood sugar(8 weeks)
- Hemoglobin(8 weeks)
- SIRT1 (NAD-dependent deacetylase sirtuin-1)(8 weeks)
- Blood urea nitrogen(8 weeks)
- Alanine aminotransferase(8 weeks)
- Creatinine(8 weeks)
- Aspartate transaminase(8 weeks)
- Alkaline phosphatase(8 weeks)
Investigators
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University
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