Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)

Last updated: January 6, 2025
Sponsor: University of Aberdeen
Overall Status: Completed

Phase

N/A

Condition

Diabetes Prevention

Weight Loss

Treatment

Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss

Phase 1 Control

Phase 2 High Fibre Weight Loss

Clinical Study ID

NCT05892003
814
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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

  • 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 current weight loss programme (that may be affecting lifestyle,physical activity & diet) or undergone gastric band/reduction surgery

  • 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

Current sweetener consumption will not be an exclusion criteria as the Phase 1 - CTRL and Phase 2 - HF WL diets will provide enough of a washout (4 weeks) before the Phase 3 diets containing sucralose are consumed. Participants who do habitually consume sweeteners will be asked not to use them during the study.

Study Design

Total Participants: 20
Treatment Group(s): 3
Primary Treatment: Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss
Phase:
Study Start date:
May 12, 2023
Estimated Completion Date:
December 16, 2024

Connect with a study center

  • Rowett Institute, University of Aberdeen

    Aberdeen, AB25 2ZD
    United Kingdom

    Site Not Available

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