Double-blind, randomized, placebo-controlled assessment of the antioxidant efficacy of an ingredient to be used in food supplements (ROC H clinical trial 2020)” aimed to assess the efficacy of Red Orange Complex H

BIONAP srl0 sites60 target enrollmentSeptember 20, 2022

Overview

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36296919/ (added 07/11/2023)

Registry

who.int

Start Date

September 20, 2022

End Date

March 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Men (50%) and women (50%) aged 45\-60 years old
•2\. Subjects with menopausal symptoms (only for women)
•3\. Subjects naïve to treatment and food supplements that can interfere with the study treatment for the previous 1 month
•4\. Not used topical products/food supplements with similar effects to the product being tested (antioxidant) during the entire study period
•5\. Subjects registered with health social security or health social insurance
•6\. Subjects reading, understanding and signed approval of the informative consent
•7\. Not vegetarian
•8\. Subjects who will continue their normal lifestyle
•9\. Healthy subjects without clinical illness diagnosed with relevant diseases of the gastrointestinal system or visceral motility
•10\. Not pregnant

•1\. Subjects who do not fit the inclusion criteria
•2\. Subjects \<45 and \>60 years old
•3\. Clinical history of relevant present disorders or administration of drugs/food supplements that can potentially interfere with the treatment under study
•4\. Lack of compliance defined as not using the correct dose or placebo for \>1 week, and the inability to give informed consent
•5\. Subjects who have changed their diet significantly or have been placed on weight reduction products
•6\. Smokers, obese subjects
•7\. Subjects changing their eating habits within the 2 weeks previous to the screening
•8\. Pregnancy or subjects planning a pregnancy
•9\. Breastfeeding
•10\. Subjects with a history of drug, alcohol, and other substance abuse