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Clinical Trials/NCT05892003
NCT05892003
Completed
Not Applicable

Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre and Non-Nutritive Sweeteners

University of Aberdeen1 site in 1 country20 target enrollmentMay 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Appetitive Behavior
Sponsor
University of Aberdeen
Enrollment
20
Locations
1
Primary Endpoint
Change in gut metabolites (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Status
Completed
Last Updated
last year

Overview

Brief Summary

The investigators present a weight loss diet intervention study, to be conducted as a within-subject design, with all food and beverages provided, to assess interaction of non-nutritive sweetener (sucralose) with a high-fibre weight loss diet, on markers of gut health in humans. This study will allow assessment of the effects of a non-nutritive sweetener (sucralose) with a high-fibre (soluble fibre, fructo-oligosaccharides, FOS) diet on metabolic health and activity and composition of gut microbiota, by a controlled human diet intervention study. The investigators propose to recruit participants living with obesity, with a poor diet quality (moderate habitual fibre intake) to additionally address diet inequalities in the research approach, and this will also allow examine the time-course of adaptation of the gut microbiome (measured in faecal samples). The investigators will also assess changes in free-living glycaemic control with addition of dietary fibre and bio-markers of health.

Registry
clinicaltrials.gov
Start Date
May 12, 2023
End Date
December 16, 2024
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 (postmenopausal, using the oral contraceptive pill or some form of hormonal contraceptive)
  • moderate habitual fibre intake (18-23g/day)

Exclusion Criteria

  • Medication exclusion criteria:
  • antibiotic use (within the past 3 months due to impact on gut microbiota)
  • anti-depressants (current)
  • smoking or vaping
  • weight loss medication
  • 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

Outcomes

Primary Outcomes

Change in gut metabolites (from faecal samples) in response to dietary fibre and non-nutritive sweetener

Time Frame: At baseline and end of each arm (study days 1, 15, 29 and 43)

Measured by changes in faecal short chain fatty acids concentrations

Change in gut microbiome composition (from faecal samples) in response to dietary fibre and non-nutritive sweetener

Time Frame: At baseline and end of each arm (study days 1, 15, 29 and 43)

Measured by changes in bacterial 16S ribosomal ribonucleic acid gene sequencing; 16S rRNA

Change in gut metabolite production (from faecal samples) in response to dietary fibre and non-nutritive sweetener

Time Frame: At baseline and end of each arm (study days 1, 15, 29 and 43)

Measured by changes in calprotectin concentrations

Secondary Outcomes

  • Change in glycaemic control in response to dietary fibre and non-nutritive sweetener(At baseline and end of each arm (study days 1, 15, 29 and 43))
  • Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener(every day of study diets (42days))

Study Sites (1)

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