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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Preliminary Pilot Exploratory Investigations Into the Effects of io Fibrewater Supplementation on Body Composition Parameters, Blood Chemistry and Cognitive, Psychological, and Behavioural Factors in Overweight Adults

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Enriched fibre water


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Females and males, aged 18 years to 65 years BMI ≥25 kg/m2 with any of the following: IGT (blood glucose level of 7.8-11.0 mmol/L after a 2-hour oral glucose tolerance test (OGTT)), or IFG (fasting blood glucose level of 5.6-6.9 mmol/L) or impaired HbA1c (HbA1c level of 5.7%-6.4%) Not dieting within the last month not having lost >5% body weight in the previous year Not increased physical activity levels in the past 2-4 weeks or intending to modify them during the study. Understands and is willing, able and likely to comply with all study procedures and restriction including being willing to follow the nutritional advice. Able to eat most everyday foods with no current IBS symptoms. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iowater fibre Group<br>This exclusive 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. | Dietary Supplement: Enriched fibre water<br>* 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.<br>* Other names: Io fibre water;|
| Placebo Comparator: Volvic Placebo control Group<br>This is the equivalent placebo control water that it is matching the energy values | Dietary Supplement: Enriched fibre water<br>* 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.<br>* Other names: Io fibre water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric measurements | Body fat percentage | Change in body fat percentage from baseline and after 30 days of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure readings | Change in blood pressure from baseline and after 30 days of intervention | 
| Gastrointestinal symptoms | Details of bowel habits including stool frequency and consistency (Bristol stool scale), stomach or intestinal bloating, abdominal pain, incidence and frequency of flatulence | 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 | 
| Gut microbiota composition | Details on the gut microbiota composition | Change in gut microbiota composition from baseline and after 30 days of intervention | 
| Fasting blood glucose via OGGT | 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. | Change in plasma blood glucose from baseline and after 30 days of intervention | 
| Neurocognitive and Mood Assessment | 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. | Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention |