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

NCT05892003 | Completed DMC

• 1 other identifier: 814
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Appetitive Behavior

Keywords

fibre; non-nutritive sweetener; weight loss; gut microbiome; glycaemic control

Outcome Measures

Primary Outcomes (3)

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

  Measured by changes in faecal short chain fatty acids concentrations

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

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

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

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

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

  Measured by changes in calprotectin concentrations

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

Secondary Outcomes (2)

• Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener

  every day of study diets (42days)

• 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)

Other Outcomes (22)

• Change in concentration of blood metabolites 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 concentration of gut hormones 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 lipid profile in response to dietary fibre and non-nutritive sweetener

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

Study Arms (1)

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

EXPERIMENTAL

* 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.

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

Interventions

Phase 1 Control OTHER

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).

Also known as: CTRL

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

Phase 2 High Fibre Weight Loss OTHER

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.

Also known as: HF WL

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

Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss OTHER

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.

Also known as: HF-NNS WL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Rowett Institute, University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Appetitive Behavior; Weight Loss

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandra Johnstone, Prof

  Rowett Institute, University of Aberdeen

  PRINCIPAL INVESTIGATOR

• Alexander Ross, Dr

  Rowett Institute, University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: June 7, 2023
• Study Start: May 12, 2023
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)