Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet) (NCT05892003) | Clinical Trial Compass
CompletedNot Applicable
Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)
United Kingdom20 participantsStarted 2023-05-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 P…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in gut metabolites (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Timeframe: At baseline and end of each arm (study days 1, 15, 29 and 43)
2
Change in gut microbiome composition (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Timeframe: At baseline and end of each arm (study days 1, 15, 29 and 43)
3
Change in gut metabolite production (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Timeframe: At baseline and end of each arm (study days 1, 15, 29 and 43)