The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults
NCT ID: NCT05908474
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2023-04-25
2024-10-12
Brief Summary
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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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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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iowater fibre Group
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.
Enriched 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.
Volvic Placebo control Group
This is the equivalent placebo control water that it is matching the energy values
Enriched 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.
Interventions
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Enriched 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
18 Years
65 Years
ALL
Yes
Sponsors
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University of Roehampton
OTHER
Responsible Party
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DR ADELE COSTABILE
Associate Professor in Health Sciences and Nutrition
Principal Investigators
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Adele Costabile
Role: STUDY_DIRECTOR
The University of Roehampton
Locations
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Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom
Countries
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Other Identifiers
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LSC 23/ 383
Identifier Type: -
Identifier Source: org_study_id