Appetitive BehaviorSSSNCT05892003
Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)
A study testing Phase 2 High Fibre Weight Loss and Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss in people with Appetitive Behavior, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior
- What is being tested?
- Phase 2 High Fibre Weight Loss and Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 May 2023to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
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- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Rowett Institute, University of Aberdeen
Aberdeen, AB25 2ZD
About this study
Official title: Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre and Non-Nutritive Sweeteners
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
- Being tested
- Phase 1 Control, Phase 2 High Fibre Weight Loss, Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss
- Keywords
- fibre, non-nutritive sweetener, weight loss, gut microbiome, glycaemic control
- Medical subject headings
- Appetitive Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1 ControlOther
Also called CTRL
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).
Phase 2 High Fibre Weight LossOther
Also called HF WL
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.
Phase 3 High Fibre and Non-Nutritive Sweetener Weight LossOther
Also called HF-NNS WL
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Phase 1 Control; Other: Phase 2 High Fibre Weight Loss; Other: Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
measured using continuous glucose monitoring (CGM)
Measured: every day of study diets (42days)
Change in glycaemic control in response to dietary fibre and non-nutritive sweetener
measured by changes in fasted plasma glucose and insulin
Measured: At baseline and end of each arm (study days 1, 15, 29 and 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start12 May 2023
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appetitive BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Johnstone, Prof, Principal investigator, Rowett Institute, University of AberdeenAlexander Ross, Dr, Principal investigator, Rowett Institute, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892003
- Sponsor's protocol ID
- 814
- Acronym
- SSS
- Status last verified
- Jan 2025
- First submitted
- 17 May 2023
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre and Non-Nutritive Sweeteners
- ClinicalTrials.gov ID
- NCT05892003
- Acronym / sponsor ID
- SSS / 814
- Conditions
- Appetitive Behavior
- Keywords
- fibre, non-nutritive sweetener, weight loss, gut microbiome, glycaemic control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL | Experimental | Other: Phase 1 Control, Other: Phase 2 High Fibre Weight Loss, Other: Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase 1 ControlAlso: CTRLControl 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 | Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL |
| Phase 2 High Fibre Weight LossAlso: HF WLHigh 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 | 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 LossAlso: HF-NNS WLHigh 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. | Other | Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL |
Primary outcome
Change in gut metabolites (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Time frame: At baseline and end of each arm (study days 1, 15, 29 and 43)
Measured by changes in faecal short chain fatty acids concentrations
Change in gut microbiome composition (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Time frame: At baseline and end of each arm (study days 1, 15, 29 and 43)
Measured by changes in bacterial 16S ribosomal ribonucleic acid gene sequencing; 16S rRNA
Change in gut metabolite production (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Time frame: At baseline and end of each arm (study days 1, 15, 29 and 43)
Measured by changes in calprotectin concentrations
2 secondary outcomes
Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener
Time frame: every day of study diets (42days)
Change in glycaemic control in response to dietary fibre and non-nutritive sweetener
Time frame: At baseline and end of each arm (study days 1, 15, 29 and 43)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Johnstone, Prof principal investigator
Rowett Institute, University of Aberdeen
Alexander Ross, Dr principal investigator
Rowett Institute, University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 2 High Fibre Weight Loss and Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss in people with Appetitive Behavior, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut metabolites (from faecal samples) in response to dietary fibre and non-nutritive sweetener (time frame: At baseline and end of each arm (study days 1, 15, 29 and 43)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.