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

University of Roehampton

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Enriched fibre water

Study type: Interventional

Funder types: Other

Identifiers

NCT05908474

LSC 23/ 383

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

iowater fibre Group

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Enriched fibre water

Volvic Placebo control Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Enriched fibre water