Status:
COMPLETED
Polyphenol Supplementation and Morbid Obesity Parameters
Lead Sponsor:
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
Morbid Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This parallel, double-blind, randomised controlled trial aims to assess the effect of a polyphenol-rich dietary supplement on obesity parameters, in combination with a hypocaloric diet, for adults wit...
Detailed Description
The main objective of this study is to assess the effect of a polyphenol-rich dietary supplement, along with a hypocaloric diet, on obesity parameters in participants with morbid obesity. Anthropometr...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years old
- Presenting morbid obesity defined as BMI ≥ 40 kg/m2
- Referred to the Endocrinology and Nutrition Unit from Bellvitge University Hospital for a weight loss treatment
Exclusion
- History of type I diabetes
- Endocrine disorders-derived obesity
- Acute metabolic complications
- Severe inflammatory process that might affect the inflammatory condition during the 4 weeks before inclusion
- Cardiovascular event during the 6 months before inclusion
- History of hepatopathy or alteration of hepatic function
- Pregnant, lactation period or willing to get pregnant in the 12 weeks after inclusion
- Recent history of neoplasia (\< 5 years) except for skin cancer or melanoma
- Oral or IV line glucocorticoids during 14 consecutive days or more 3 months before inclusion
- Alcoholism, drug addiction or major psychiatric disorder
Key Trial Info
Start Date :
August 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05428540
Start Date
August 8 2022
End Date
June 16 2023
Last Update
August 9 2023
Active Locations (1)
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1
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907