MedPath

Effect of Astaxanthin, Natural plant-based Oil, Vitamin E and VitaminD3 on Inflammatory Biomarkers in Overweight and Obese Women : A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Phase 1
Conditions
Overweight and obese healthy women
Astaxanthin
Overweight
Obese
Inflammation
hs CRP
TNF alpha
Registration Number
TCTR20210305003
Lead Sponsor
Prevent U Company Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
Female
Target Recruitment
38
Inclusion Criteria

1. Female 2. Aged 35-45 years old 3. BMI 23-29.99 kg/m2 4. Normal physical and mental health 5. No underlying disease 6. No menopause condition 7. No history of Carotenoids allergy 8. No smoking 9. No pregnancy or Lactation 10. No taking of dietary supplement within 2 weeks prior to participation

Exclusion Criteria

1. Willingness or having necessary reason to withdraw from participation 2. Allergy or adverse event occurred during participation 3. Pregnancy 4. Forget to take softgels for more than two consecutive days or more than two times per week or more than four days per month 5. Intention to lose weight or lifestyle modification

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Inflammatory biomarker week 0, 8 hs CRP,Inflammatory biomarker week 0, 8 TNF alpha
Secondary Outcome Measures
NameTimeMethod
Safety week 0, 8 Blood Urea Nitrogen,Safety week 0, 8 Creatinine,Safety week 0, 8 Aspartate aminotransferase,Safety week 0, 8 Alanine aminotransferase
© Copyright 2025. All Rights Reserved by MedPath