Focus on Fibre Study

NCT ID: NCT05449665

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-14

Study Completion Date

2023-12-31

Brief Summary

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The investigators present a diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to allow ad libitum feeding to assess impact of diet change on appetite response. The diets will vary in fibre content and type. This study will allow assessment of the physiological impact of dietary fibre on markers of appetite control for body weight, measured from plasma gut hormones. The investigators propose to recruit participants with a poor diet quality (low habitual fibre intake) to additionally examine the time-course of adaptation of the gut microbiome (measured in faecal samples), whilst assessing the impact of added fibre on body weight and subjective appetite scores. This approach is to address the impact of dietary fibre in people living with obesity and food inequalities. The investigators will assess physiological bio-markers of appetite control and their contribution to the development of a gut ecosystem that promotes health. A subsequent period of return to a low fibre feeding will allow assessment of durability of response.

Detailed Description

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Conditions

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Appetitive Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control - High Fibre - Low Fibre (CTRL - HF - LF)

* Phase 1 - CTRL: Control diet with moderate fibre consumption for 13days.
* Phase 2 - HF: ad libitum consumption of HF meals for 13days.
* Phase 3 - LF: ad libitum consumption of LF meals for 13days.

Group Type EXPERIMENTAL

Phase 1 - Control

Intervention Type OTHER

Control diet (30% Fat, 15% Protein, 55% Carbohydrate, Fibre rising from 10 to 16g/d).

Fed to energy balance (1.5 x Resting Metabolic Rate, RMR).

Phase 2 - High Fibre

Intervention Type OTHER

High Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 30g/day Fibre). Fed ad libitum, contains 20g/day pectin (split over breakfast, lunch and dinner) in drinks/yoghurts which will be compulsory to consume and 10g/day fibre coming from the diet provided.

Phase 3 - Low Fibre

Intervention Type OTHER

Low Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 10g/day Fibre). Fed ad libitum.

Interventions

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Phase 1 - Control

Control diet (30% Fat, 15% Protein, 55% Carbohydrate, Fibre rising from 10 to 16g/d).

Fed to energy balance (1.5 x Resting Metabolic Rate, RMR).

Intervention Type OTHER

Phase 2 - High Fibre

High Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 30g/day Fibre). Fed ad libitum, contains 20g/day pectin (split over breakfast, lunch and dinner) in drinks/yoghurts which will be compulsory to consume and 10g/day fibre coming from the diet provided.

Intervention Type OTHER

Phase 3 - Low Fibre

Low Fibre diet (30% Fat, 15% Protein, 55% Carbohydrate, 10g/day Fibre). Fed ad libitum.

Intervention Type OTHER

Other Intervention Names

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Phase 1 - CTRL HF LF

Eligibility Criteria

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Inclusion Criteria

* healthy but overweight/obese (BMI 28-40kg/m2) males and females (post-menopausal, using the oral contraceptive pill or some form of hormonal contraceptive)
* low habitual fibre intake (\<10g/day)

Exclusion Criteria

* antibiotic use (within the past 3 months due to impact on gut microbiota)
* statins (current)
* aspirin or other NSAIDs or anti-coagulants (current)
* anti-depressants (current)
* smoking or vaping


* Females who are planning to be pregnant, are pregnant or are breastfeeding
* Anyone with food allergies, self-reported food sensitivity or intolerance
* Anyone with coeliac disease or gluten intolerance
* Anyone taking medication which may affect their appetite
* Anyone with an eating disorder
* Anyone with diabetes
* Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout
* Anyone suffering from a psychiatric disorder or any type of substance abuse
* Anyone suffering from unregulated thyroid disease


* Anyone following a vegetarian or vegan diet
* Anyone following a weight loss programme (that may be affecting lifestyle, physical activity \& diet)
* Anyone with unsuitable veins for blood sampling
* Anyone who is unable to fluently speak, read and understand English
* Anyone who is unable to comply to an alcohol-free diet for 6 weeks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandra Johnstone, Prof

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute, University of Aberdeen

Alexander Ross, Dr

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute, University of Aberdeen

Locations

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Rowett Institute, University of Aberdeen

Aberdeen, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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813

Identifier Type: -

Identifier Source: org_study_id

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