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Clinical Trials/NCT05449665
NCT05449665
Terminated
Not Applicable

Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre

University of Aberdeen1 site in 1 country7 target enrollmentJune 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Appetitive Behavior
Sponsor
University of Aberdeen
Enrollment
7
Locations
1
Primary Endpoint
Change in gut hormones to assess appetite response to dietary fibre
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 14, 2022
End Date
December 31, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in gut hormones to assess appetite response to dietary fibre

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

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

Change in subjective hunger to assess appetite response to dietary fibre

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

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

Secondary Outcomes

  • 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))

Study Sites (1)

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