Focus on Fibre Study

NCT05449665 | Terminated DMC

• 1 other identifier: 813
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appetitive Behavior

Keywords

fibre; appetite control; gut microbiome; glycaemic control

Outcome Measures

Primary Outcomes (2)

• Change in gut hormones to assess appetite response to dietary fibre

  measured by acute and chronic changes in plasma ghrelin and peptide YY (PYY)

  At baseline and end of each arm (study days 0, 14, 28 and 42)

• Change in subjective hunger to assess appetite response to dietary fibre

  measured by acute and chronic changes in appetite using visual analogue scale questionnaires

  At baseline and end of each arm (study days 0, 14, 28 and 42)

Secondary Outcomes (3)

• Change in gut metabolites (from faecal samples) in response to dietary fibre

  At baseline and end of each arm (study days 0, 14, 28 and 42)

• Change in gut microbiome composition (from faecal samples) in response to dietary fibre

  At baseline and end of each arm (study days 0, 14, 28 and 42)

• Change in glycaemic control in response to dietary fibre

  At baseline and end of each arm (study days 0, 14, 28 and 42)

Other Outcomes (13)

• Change in blood metabolites in response to dietary fibre

  At baseline and end of each arm (study days 0, 14, 28 and 42)

• Change in lipid profile in response to dietary fibre

  At baseline and end of each arm (study days 0, 14, 28 and 42)

• Change in diet markers in response to dietary fibre

  At baseline and end of each arm (study days 0, 14, 28 and 42)

Study Arms (1)

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

EXPERIMENTAL

* 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.

Other: Phase 1 - Control; Other: Phase 2 - High Fibre; Other: Phase 3 - Low Fibre

Interventions

Phase 1 - Control 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).

Also known as: Phase 1 - CTRL

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

Phase 2 - High Fibre 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.

Also known as: HF

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

Phase 3 - Low Fibre OTHER

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

Also known as: LF

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute, University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Appetitive Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Alexandra Johnstone, Prof

  Rowett Institute, University of Aberdeen

  PRINCIPAL INVESTIGATOR

• Alexander Ross, Dr

  Rowett Institute, University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 8, 2022
• Study Start: June 14, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)