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OpenTrials
Completed

NCT Number: NCT05908474

The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

London, UK, SW15 4JD, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

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.

Other names: Io fibre water

Primary outcomes

  1. Anthropometric measurements

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

    Body fat percentage

Secondary outcomes

  1. Blood pressure

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

    Blood pressure readings

  2. 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

    Details of bowel habits including stool frequency and consistency (Bristol stool scale), stomach or intestinal bloating, abdominal pain, incidence and frequency of flatulence

  3. Gut microbiota composition

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

    Details on the gut microbiota composition

  4. Fasting blood glucose via OGGT

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

    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.

  5. Neurocognitive and Mood Assessment

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

    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.

Sponsors and collaborators

Lead sponsor

University of Roehampton

Other

Registry information

Official study 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

Acronym: IOFW

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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