Liquid Food Supplements and Vascular Function
Research type
Research Study
Full title
Efficacy and Safety of GOLD COLLAGEN® Liquid Food Supplements on Vascular Function: a Pilot Double Blind Randomized Placebo Controlled Clinical Trial
IRAS ID
244409
Contact name
Francesco D'Aiuto
Contact email
Sponsor organisation
Minerva Research Labs Limited
Clinicaltrials.gov Identifier
Perio-16-64, Periodontal study number
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Mutiple sources of evidence exist highlighting the potential beneficial effects of supplemental antioxidants to overall health. However, less evidence exists as to the mechanisms behind these potential health benefits or potential effects on oral health as a part of general health. The aim of this study is investigate the impact of GOLD COLLAGEN® liquid food supplementation containing a blend of vitamins, antioxidants and hydrolysed collagen on the endothelial function in healthy participants. In this study participants will be randomised to one of three groups: GOLD COLLAGEN® FORTE supplement, GOLD COLLAGEN® RX supplement or Placebo. The study which will take place in one centre and will recruit 153 (51 per group) generally healthy volunteers between the age of 30 and 60 years old of any ethnic background. All participants will be asked to take the provided supplement (or placebo) once per day for 12 weeks. Each participant will be asked to attend for a screening visit to confirm eligibility, a baseline visit for baseline measurements and follow-up visits at 12 weeks and 24 weeks after beginning intake of the supplements according to randomised group mentioned above. Baseline Measurements will include an oral examination, an ultrasound scan of the brachial artery in the arm, computer scan images of the skin, a finger nail and oral tissue, a photograph of their skin and collection of blood, stool (20 patients only) and saliva samples. These measurements and sample collections will be repeated at the 12 and 24 week visits.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1103
Date of REC Opinion
3 Aug 2018
REC opinion
Further Information Favourable Opinion