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

NCT05908474 | Completed DMC

• 1 other identifier: LSC 23/ 383
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Anthropometric measurements

  Body fat percentage

  Change in body fat percentage from baseline and after 30 days of intervention

Secondary Outcomes (5)

• Blood pressure

  Change in blood pressure from baseline and after 30 days of intervention

• 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

• Gut microbiota composition

  Change in gut microbiota composition from baseline and after 30 days of intervention

• Fasting blood glucose via OGGT

  Change in plasma blood glucose from baseline and after 30 days of intervention

• Neurocognitive and Mood Assessment

  Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention

Study Arms (2)

iowater fibre Group

ACTIVE COMPARATOR

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

Volvic Placebo control Group

PLACEBO COMPARATOR

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

Dietary Supplement: Enriched fibre water

Interventions

Enriched fibre water DIETARY_SUPPLEMENT

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.

Also known as: Io fibre water

Volvic Placebo control Group; iowater fibre Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of Roehampton: lead

Study Sites (1)

Health Sciences Research Centre, Life Sciences Department, University of Roehampton

London, UK, SW15 4JD, United Kingdom

Location

Study Officials

• Adele Costabile

  The University of Roehampton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Health Sciences and Nutrition

Model Details: A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 18, 2023
• Study Start: April 25, 2023
• Primary Completion: September 15, 2024
• Study Completion: October 12, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)