Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416254
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-03
Brief Title:
The Fibre Full Study
Sponsor:
University College Cork
Organization:
University College Cork
Study Overview
Official Title:
The Effects of a Diet Enriched With Dietary Fibre on Glycaemic Response Gastrointestinal Tolerability Satiety and Microbiome Functionality The Fibre Full Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 25-35kgm2
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
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
Detailed Description:
Participants Healthy men and pre-menopausal non-pregnant and non-lactating women 18-45 years of age with a Body Mass Index BMI between 25-349 kgm2 will be recruited n20
Study Design This exploratory study aims to investigate the effects of a fibre-enriched FR diet in adults with excess body weight in comparison to a control diet This randomized single-blinded placebo-controlled interventiontrial with a crossover design compares the effects of consumption of fibre-enriched food staples delivered within a full meal plan fibre-enriched diet plan with a matched control meal plan control diet plan
Participants stratified by age and BMI will be randomly assigned to receive either the control diet or fibre-enriched FR diet for 8 days After these 8 days a washout period 13 day minimum will commence and participants will then crossover to the opposite diet All foods and prepared meals within the menu plan will be provided to participants for both the control and FR diets Participants are required to strictly adhere to their assigned meal plan for the 8-day period
Given the higher dietary fibre intake of the FR-diet the study design incorporates a dose escalation of the fibre content to allow participants on the FR diet to adjust to the increase in dietary fibre intake 4-day reduced dose wherein study foods contain only a portion of the required dose of fibre and 4-day full dose high fibre intake
The effect of the FR diet on satiety and overall food intake will be assessed Participants on the FR diet and the control diet will be provided with non-fibre enriched snacks which they may consume at designated times each day if they wish to and in ab libitum These snacks will be an optional component of the menu plan All food intakes will be monitored and all leftovers will be returned to the research team Additionally dietary assessments will be completed at regular intervals
Study Treatments
The FR diet consists of a full meal plan containing engineered common food products with decreased energy density and glycaemic index in which a large proportion of refined carbohydrates are replaced with dietary fibre
The control diet consists of a full meal plan with non-fibre enriched food products
Study Outcome measures will include post-prandial glycaemic response satiety gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight BMI 25-35kgm2
Study Design This exploratory study aims to investigate the effects of a fibre-enriched FR diet in adults with excess body weight in comparison to a control diet This randomized single-blinded placebo-controlled interventiontrial with a crossover design compares the effects of consumption of fibre-enriched food staples delivered within a full meal plan fibre-enriched diet plan with a matched control meal plan control diet plan
Participants stratified by age and BMI will be randomly assigned to receive either the control diet or fibre-enriched FR diet for 8 days After these 8 days a washout period 13 day minimum will commence and participants will then crossover to the opposite diet All foods and prepared meals within the menu plan will be provided to participants for both the control and FR diets Participants are required to strictly adhere to their assigned meal plan for the 8-day period
Given the higher dietary fibre intake of the FR-diet the study design incorporates a dose escalation of the fibre content to allow participants on the FR diet to adjust to the increase in dietary fibre intake 4-day reduced dose wherein study foods contain only a portion of the required dose of fibre and 4-day full dose high fibre intake
The effect of the FR diet on satiety and overall food intake will be assessed Participants on the FR diet and the control diet will be provided with non-fibre enriched snacks which they may consume at designated times each day if they wish to and in ab libitum These snacks will be an optional component of the menu plan All food intakes will be monitored and all leftovers will be returned to the research team Additionally dietary assessments will be completed at regular intervals
Study Treatments
The FR diet consists of a full meal plan containing engineered common food products with decreased energy density and glycaemic index in which a large proportion of refined carbohydrates are replaced with dietary fibre
The control diet consists of a full meal plan with non-fibre enriched food products
Study Outcome measures will include post-prandial glycaemic response satiety gastrointestinal tolerability and gut microbiota composition and function in individuals with excess body weight BMI 25-35kgm2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None