Assessing FMD in overweight adults

About the Study Between August 2016 and March 2017, overweight and obese subjects with mild hypertension were recruited by Atlantia Food Clinical Trials in our Cork facility in Ireland. After screening, healthy persons aged 25–60 years were included if their body weight was stable and their physical activity level was low to moderate. Exclusion criteria were the use of medications influencing glucose metabolism or EF and chronic or acute diseases. Smokers, heavy coffee drinkers, and pregnant women were further excluded. Throughout the study, subjects were asked to follow their usual diet and exercise routine and to avoid the named medications that could interfere with the study outcomes. The study protocol was approved by the Clinical Research Ethics Committee of the Cork Teaching Hospitals. All participants gave their written informed consent before the study’s start according to the ICH Guidelines on Good Clinical Practice and the declaration of Helsinki. Subjects were recruited through the Atlantia Food Clinical Trials database and posting adverts in local Media. An initial phone screen was performed with 400 volunteers, where subjects were asked questions regarding their age and overall health. 143 eligible subjects were scheduled for a screening visit. The study involved 3 visits over a 3 to 12-week period. 80 subjectswere randomized into the study, with 40 to receive the investigational product / placebo and 40 to receive placebo / the investigational product. Beside the screening visit, in this double-blinded, controlled, cross-over trial, participants were tested on two different. intervention days, which were separated by a 2–6 week wash-out period. On the two intervention days, the participants attended the clinic after an overnight fast of at least 10 h. To minimize confounding variables, for premenopausal women, the intervention days were within the first seven days of their menstrual cycle. Moreover, the subjects were asked to avoid high-fat and high-flavonoid foods for 24 h and caffeine for 10 h and to abstain from exercise for 12 h before the intervention. The order of the assessments was the same on both intervention days. Prior to carbohydrate load (T0), a brachial ultrasound FMD scan was performed, with blood drawn shortly thereafter. All subjects were blinded to treatment and randomly assigned to consume either 50 g of the investigational product or 50 g of placebo in the form of instant citrus drinks.

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