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

University of Aberdeen

Status: Completed

Conditions: Appetitive Behavior

Treatments: Other: Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss; Other: Phase 1 Control; Other: Phase 2 High Fibre Weight Loss

Study type: Interventional

Funder types: Other

Identifiers

NCT05892003

814

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL

Experimental group

Description:

* Phase 1 CTRL: Control diet with moderate fibre consumption for 14days. * Phase 2 HF WL: High Fibre Weight Loss meal consumption for 14days. * Phase 3 HF-NNS WL: High Fibre and Non-Nutritive Sweetener Weight Loss meal consumption for 14days.

Treatment:

Other: Phase 2 High Fibre Weight Loss

Other: Phase 1 Control

Other: Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss