Healthy Clinical Trial - The Effects of io Fibrewater Supplementation on

Status Recruiting

Clinical Trial Summary

Despite availability of many alternative and conventional weight loss options, the prevalence of obesity increased from 15% in 1993 to 27 in 2015. In 2015, 68% of men and 58% of women in the UK were overweight or obese. Overweight and obesity increase the risk for comorbidities such as hypertension, dyslipidaemia, cardiovascular disease, type 2 diabetes and certain cancers. Hormonal regulation of appetite has been shown to influence body weight and body fat . Gut hormones secreted from the intestine are particularly important both in the regulation of appetite and blood glucose level, and recently the gut hormone Glucagon Like Peptide -1 (GLP-1) has been successfully targeted to treat both type 2 diabetes and obesity. Targeting the gut microbiota has been shown to influence gut hormones, in a way is likely to help treat or prevent obesity and type 2 diabetes. In past decades, considerable attention has been given to investigating the new applications of natural prebiotic polymers on gut microbiota composition. Moreover, recent trend in research indicates a bidirectional communication between the gut microbiota and the central nervous system through the microbiome-gut-brain axis (MGBA). Therefore an in vivo intervention feeding study is proposed performed with a variety of psychological and nutritional tests aiming to compare io fibrewater with an equivalent placebo control water and also highlight both cognitive function, emotional bias and response to appetite and also metabolic profiles of the gut microbiota.

Clinical Trial Description

Study design: A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes. Participants: 20 participants will be invited to take part in this study. They will be randomly assigned to treatment (n=10) or control (n=10) groups, where they will consume io Fibrewater or Volvic sugar free Lemon & Lime water for 4 weeks. Both water samples (1 bottle/day) need to be taken with the meals (lunch). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05908474
Study type	Interventional
Source	University of Roehampton
Contact	Adele Costabile
Phone	07535721482
Email	adele.costabile@roehampton.ac.uk
Status	Recruiting
Phase	N/A
Start date	April 25, 2023
Completion date	October 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults — IOFW

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms