The Effects of a Diet Enriched With Dietary Fibre on Glycaemic Response, Gastrointestinal Tolerability, Satiety, and Microbiome Functionality (The Fibre Full Study).

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study will systematically investigate the effects of a diet with decreased energy density, reduced glycaemic index, and significantly increased dietary fibre, on post-prandial glycaemic response, satiety, gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight (Body Mass Index (BMI) 25-35kg/m2). Hypothesis: The investigators hypothesise that a diet enriched in fibre will be beneficial to post-prandial glycaemic response, well tolerated and satiating, as compared to the standard Western-style diet.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
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• Be willing and able to give written informed consent.

• Be between 18 and 45 years of age

• Have a Body Mass Index (BMI) of 25-34.9kg/m2 (Overweight or Obese Class I)

• Have had a stable body weight (≤5% change over the past three months)

• Be in general good health as determined by the investigator through interview and vital signs (blood pressure, pulse, temperature). Systolic blood pressure less than 160mm Hg and diastolic blood pressure less than 100 mm Hg (defined as Hypertension stage 2).

• Be willing to avoid consuming dietary supplements, prebiotics, probiotics, or fibre-rich supplements within four weeks prior to the baseline visit, and until the end of the study.

• Be willing to avoid physical exercise for the duration of the study (physical exercise defined as any physical activity that is planned to achieve a fitness goal)

• Be willing to consume the investigational products daily for the duration of the study.

Locations
Other Locations
Ireland
University College Cork
RECRUITING
Cork
Contact Information
Primary
Study Coordinator
fibrestudy@ucc.ie
086 199 2919
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Active_comparator: Fibre-enriched
During the fibre-enriched arm, participants will receive the fibre-rich diet containing fibre-enriched foods provided through a full meal plan to be consumed throughout the day.
Placebo_comparator: Control
During the control arm, participants will receive a non-fibre enriched diet consisting of matched control foods provided through a full meal plan otherwise identical to the fibre-enriched arm.
Related Therapeutic Areas
Sponsors
Leads: University College Cork

This content was sourced from clinicaltrials.gov