NCT05892003

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Appetitive Behavior

Interventions

Type	Name	Description
OTHER	Phase 1 Control	Control diet (30% Fat, 15% Protein, 55% Carbohydrate, Fibre rising from 10 to 16g/d). Fed to energy balance (1.5 x Resting Metabolic Rate, RMR).
OTHER	Phase 2 High Fibre Weight Loss	High Fibre Weight Loss diet (30% Fat, 15% Protein, 55% Carbohydrate). Fed to energy deficit (100% RMR). The quantity of fructo-oligosaccharides (FOS) will be fixed at 20g/day for all kcal levels with additional fibre coming from the diet provided. The FOS will be split over breakfast, lunch and dinner in drinks/yoghurts which will be compulsory to consume.
OTHER	Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss	High Fibre and Non-Nutritive Sweetener Weight Loss diet (30% Fat, 15% Protein, 55% Carbohydrate). Fed to energy deficit (100% RMR). The quantity of fructo-oligosaccharides (FOS) and non-nutritive sweetener (sucralose) will be fixed at 20g/day and 30mg/day respectively for all kcal levels with additional fibre coming from the diet provided. The FOS and sucralose will be split over breakfast, lunch and dinner in drinks/yoghurts which will be compulsory to consume.

Timeline

• Start date: 2023-05-12
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2023-06-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: United Kingdom