Focus on Fibre Study

University of Aberdeen

Status: Terminated

Conditions: Appetitive Behavior

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05449665

813

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Medication 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

Medical exclusion criteria:

• 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

Other exclusion criteria:

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

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

Experimental group

Description:

* 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.

Treatment:

Other: Phase 3 - Low Fibre

Other: Phase 1 - Control

Other: Phase 2 - High Fibre