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

Primary Purpose

Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Enriched fibre water
Sponsored by
University of Roehampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Health Sciences Research Centre, Life Sciences Department, University of RoehamptonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

iowater fibre Group

Volvic Placebo control Group

Arm Description

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.

This is the equivalent placebo control water that it is matching the energy values

Outcomes

Primary Outcome Measures

Anthropometric measurements
Body fat percentage

Secondary Outcome Measures

Blood pressure
Blood pressure readings
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
Gut microbiota composition
Details on the gut microbiota composition
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.
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.

Full Information

First Posted
May 31, 2023
Last Updated
June 9, 2023
Sponsor
University of Roehampton
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1. Study Identification

Unique Protocol Identification Number
NCT05908474
Brief Title
The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults
Acronym
IOFW
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roehampton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iowater fibre Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Volvic Placebo control Group
Arm Type
Placebo Comparator
Arm Description
This is the equivalent placebo control water that it is matching the energy values
Intervention Type
Dietary Supplement
Intervention Name(s)
Enriched fibre water
Other Intervention Name(s)
Io fibre water
Intervention Description
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 Outcome Measure Information:
Title
Anthropometric measurements
Description
Body fat percentage
Time Frame
Change in body fat percentage from baseline and after 30 days of intervention
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure readings
Time Frame
Change in blood pressure from baseline and after 30 days of intervention
Title
Gastrointestinal symptoms
Description
Details of bowel habits including stool frequency and consistency (Bristol stool scale), stomach or intestinal bloating, abdominal pain, incidence and frequency of flatulence
Time Frame
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
Title
Gut microbiota composition
Description
Details on the gut microbiota composition
Time Frame
Change in gut microbiota composition from baseline and after 30 days of intervention
Title
Fasting blood glucose via OGGT
Description
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.
Time Frame
Change in plasma blood glucose from baseline and after 30 days of intervention
Title
Neurocognitive and Mood Assessment
Description
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.
Time Frame
Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adele Costabile
Phone
07535721482
Email
adele.costabile@roehampton.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Piril Hepsomali
Phone
+44 (0)20 8392 7151
Email
p.hepsomali@roehampton.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adele Costabile
Organizational Affiliation
The University of Roehampton
Official's Role
Study Director
Facility Information:
Facility Name
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
City
London
State/Province
UK
ZIP/Postal Code
SW15 4JD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adele Costabile
First Name & Middle Initial & Last Name & Degree
Adele Costabile
Phone
+44 (0) 20 8392 3571
Email
adele.costabile@roehampton.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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