HealthyIOFWNCT05908474
The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults
A study testing Enriched fibre water in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Enriched fibre water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2023to 12 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, SW15 4JD
About this study
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
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Enriched fibre water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched fibre waterDietary supplement
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Dietary Supplement: Enriched fibre water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
Body fat percentage
Measured: Change in body fat percentage from baseline and after 30 days of intervention
Secondary outcomes (5)
Blood pressure
Blood pressure readings
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Apr 2023
- Primary completion15 Sep 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- Adele Costabile, Study director, The University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908474
- Sponsor's protocol ID
- LSC 23/ 383
- Acronym
- IOFW
- Status last verified
- Nov 2024
- First submitted
- 31 May 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05908474
- Acronym / sponsor ID
- IOFW / LSC 23/ 383
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes
| Arm | Type | Receives |
|---|---|---|
| iowater fibre Group | Active comparator | Dietary Supplement: Enriched fibre waterThis 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. |
| Volvic Placebo control Group | Placebo comparator | Dietary Supplement: Enriched fibre waterThis is the equivalent placebo control water that it is matching the energy values |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Exclusion criteria Current use of prescribed medication for neuropsychiatric disorders or history of neuropsychiatric disorders
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enriched fibre waterAlso: Io fibre waterBlend 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 | Volvic Placebo control Group, iowater fibre Group |
Primary outcome
Anthropometric measurements
Time frame: Change in body fat percentage from baseline and after 30 days of intervention
Body fat percentage
5 secondary outcomes
Blood pressure
Time frame: Change in blood pressure from baseline and after 30 days of intervention
Gastrointestinal symptoms
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
Gut microbiota composition
Time frame: Change in gut microbiota composition from baseline and after 30 days of intervention
Fasting blood glucose via OGGT
Time frame: Change in plasma blood glucose from baseline and after 30 days of intervention
Neurocognitive and Mood Assessment
Time frame: Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Costabile study director
The University of Roehampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enriched fibre water in people with Healthy, run by University of Roehampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (time frame: Change in body fat percentage from baseline and after 30 days of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.