Clinical trial NCT05908474: The Effects of io Fibrewater Supplementation on Gut Health, Immunity and Metabolism in Overweight Adults
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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Roehampton
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A 30-day placebo-controlled randomised trial study in overweight adults who have not been diagnosed with Diabetes
Primary purpose: TREATMENT

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).

Eligibility criteria: * Inclusion criteria

  1. Females and males, aged 18 years to 65 years
  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)
* Exclusion criteria Current use of prescribed medication for neuropsychiatric disorders or history of neuropsychiatric disorders

Primary outcomes:
measure: Anthropometric measurements
timeFrame: Change in body fat percentage from baseline and after 30 days of intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: Change in blood pressure from baseline and after 30 days of intervention
measure: Gastrointestinal symptoms
timeFrame: 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
measure: Gut microbiota composition
timeFrame: Change in gut microbiota composition from baseline and after 30 days of intervention
measure: Fasting blood glucose via OGGT
timeFrame: Change in plasma blood glucose from baseline and after 30 days of intervention
measure: Neurocognitive and Mood Assessment
timeFrame: Changes in Neurocognitive and Mood Assessment from baseline and after 30 days of intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Health Sciences Research Centre, Life Sciences Department, University of Roehampton
state: UK
Study officials:
affiliation: The University of Roehampton
name: Adele Costabile
role: STUDY_DIRECTOR
References: