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

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).

• Enriched fibre water (Dietary supplement), also known as Io fibre water: Blend of scientifically substantiated ingredients has been demonstrated to contribute to the reduction of body weight and aid the sustainability of weight loss by providing a healthy, hunger-free weight management system. iofibrewater, makes fibre and gut health simple and refreshing. Each 500 ml bottle of ió fibrewater provides 20%* of your recommended daily fibre intake and 100%* of your daily prebiotic fibre intake with minimal calories and carbohydrates, making us suitable for people on a variety of diets. ió fibrewater is a functional water infused with prebiotic fibre (aka prebiotics), which leads to sub-optimal gut health and often the onset of digestive disorders. By adding more prebiotic fibre to our diet, we can quickly change the environment in our gut for the better healthy living.

Primary outcomes

• Anthropometric measurements [Change in body fat percentage from baseline and after 30 days of intervention]: Body fat percentage

Secondary outcomes

• Blood pressure [Change in blood pressure from baseline and after 30 days of intervention]: Blood pressure readings
• Gastrointestinal symptoms [Change from the baseline in bowel habits including stool frequency and consistency (Bristol stool scale), stomach or intestinal bloating, abdominal pain, incidence and frequency of flatulence]: Details of bowel habits including stool frequency and consistency (Bristol stool scale), stomach or intestinal bloating, abdominal pain, incidence and frequency of flatulence
• Gut microbiota composition [Change in gut microbiota composition from baseline and after 30 days of intervention]: Details on the gut microbiota composition
• Fasting blood glucose via OGGT [Change in plasma blood glucose from baseline and after 30 days of intervention]: A baseline sample will be take and the participants will be asked to drink 250mL of active or the equivalent placebo water. • The participants will then receive a 50 g glucose drink (orally) in 250ml of water which is commonly used to evaluate pancreatic function and the rate of changes in plasma insulin and glucose (Stumvoll, 2000) and they will donate a total of 7 venous blood samples (up to 5 ml of blood samples at each time point; 30 ml maximum total) at 15, 30, 45, 60, 75, 90, and 120 minutes.
• Neurocognitive and Mood Assessment [Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention]: Neurocognitive and Mood Assessments will take around 60 minutes, but the visits can take up to 120 mins to complete and then will be presented on Qualtrics and Inquisit. Qualtrics is an Experience Management (XM) platform hosted by the university of Roehampton. The exportation of results is only allowed for users who are granted an appropriate account permission, controlled by brand administrators from the university of Roehampton. Qualtrics follows General Data Protection Regulation (GDPR) and comply with applicable data privacy laws. Inquisit is a powerful, easy-to-use psychological measurement and experimentation tool. Inquisit is ideal for lab-based research, cognitive neuroscience, and field testing with laptops. It allows for testing of various cognitive processes including, but not limited to, attention, inhibition, working memory and decision-making.

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

* Inclusion criteria

  1. Females and males, aged 18 years to 65 years
  2. BMI ≥25 kg/m2 with any of the following:

     1. IGT (blood glucose level of 7.8-11.0 mmol/L after a 2-hour oral glucose tolerance test (OGTT)), or
     2. IFG (fasting blood glucose level of 5.6-6.9 mmol/L) or
     3. impaired HbA1c (HbA1c level of 5.7%-6.4%)
  3. Not dieting within the last month
  4. not having lost >5% body weight in the previous year
  5. Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study.
  6. Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice.
  7. Able to eat most everyday foods with no current IBS symptoms.
  8. Habitually consumes three standard meals a day (i.e., breakfast, lunch, and dinner)
* Exclusion criteria Current use of prescribed medication for neuropsychiatric disorders or history of neuropsychiatric disorders

• Adele Costabile, Study director, The University of Roehampton