Back to resultsScot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet) (SSS)
Primary Purpose
Appetitive Behavior
Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Phase 1 Control
Phase 2 High Fibre Weight Loss
Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss
Sponsored by
About this trial
This is an interventional basic science trial for Appetitive Behavior focused on measuring fibre, non-nutritive sweetener, weight loss, gut microbiome, glycaemic control
Eligibility Criteria
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.
Sites / Locations
- Rowett Institute, University of Aberdeen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL
Arm 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.
Outcomes
Primary Outcome Measures
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
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
Change in gut metabolite production (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Measured by changes in calprotectin concentrations
Secondary Outcome Measures
Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener
measured using continuous glucose monitoring (CGM)
Change in glycaemic control in response to dietary fibre and non-nutritive sweetener
measured by changes in fasted plasma glucose and insulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05892003
Brief Title
Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)
Acronym
SSS
Official Title
Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre and Non-Nutritive Sweeteners
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appetitive Behavior
Keywords
fibre, non-nutritive sweetener, weight loss, gut microbiome, glycaemic control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Phase 1 Control
Other Intervention Name(s)
CTRL
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Phase 2 High Fibre Weight Loss
Other Intervention Name(s)
HF WL
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss
Other Intervention Name(s)
HF-NNS WL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gut metabolites (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Description
Measured by changes in faecal short chain fatty acids concentrations
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Change in gut microbiome composition (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Description
Measured by changes in bacterial 16S ribosomal ribonucleic acid gene sequencing; 16S rRNA
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Change in gut metabolite production (from faecal samples) in response to dietary fibre and non-nutritive sweetener
Description
Measured by changes in calprotectin concentrations
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Secondary Outcome Measure Information:
Title
Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener
Description
measured using continuous glucose monitoring (CGM)
Time Frame
every day of study diets (42days)
Title
Change in glycaemic control in response to dietary fibre and non-nutritive sweetener
Description
measured by changes in fasted plasma glucose and insulin
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Other Pre-specified Outcome Measures:
Title
Change in concentration of blood metabolites in response to dietary fibre and non-nutritive sweetener
Description
measured by changes in fasted plasma short chain fatty acid (SCFA) concentrations
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Change in concentration of gut hormones in response to dietary fibre and non-nutritive sweetener
Description
measured by changes in fasted plasma ghrelin, GLP-1 and peptide YY (PYY) concentrations
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Change in lipid profile in response to dietary fibre and non-nutritive sweetener
Description
measured by changes in fasted plasma lipid profile (Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and non-esterified fatty acids (NEFA)
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Change in lipid ratios in response to dietary fibre and non-nutritive sweetener
Description
Total cholesterol, HDL-cholesterol and LDL-cholesterol measures will be combined to report TC to HDL and LDL to HDL ratios.
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Change in concentration of urinary metabolites in response to dietary fibre and non-nutritive sweetener
Description
changes in urinary metabolite concentrations measured by metabolomics
Time Frame
At baseline and end of each arm (study days 1, 15, 29 and 43)
Title
Height
Description
measured in metres
Time Frame
At screening visit only
Title
Change in body weight in response to dietary fibre and non-nutritive sweetener
Description
measured as weight in kilograms
Time Frame
At screening and 3 times a week on each arm (20 occasions from date of screening up to study day 43)
Title
Change in Body Mass Index (BMI) in response to dietary fibre and non-nutritive sweetener
Description
weight and height measures will be combined to report BMI in kg/m^2
Time Frame
At screening and 3 times a week on each arm (20 occasions from date of screening up to study day 43)
Title
Change in daily nausea symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced nausea today?', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily bloating symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced bloating today?', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily flatulence symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced flatulence today?', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily abdominal cramp symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced abdominal cramps today?', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily intestinal rumble symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced rumbles today? (intestinal sounds)', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily diarrhoea symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced diarrhoea today?', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily constipation symptoms in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a Likert scale 'Have you experienced constipation today?', scored as 0 - no more symptoms than usual, 1 - slightly more symptoms than usual, 2 - noticeably more symptoms than usual, 3 - considerably more symptoms than usual.
Time Frame
every day of study diets (42days)
Title
Change in daily bowel movements in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a scale 'How many bowel movements have you had today?', scored as 0, 1, 2, 3 or >3.
Time Frame
every day of study diets (42days)
Title
Change in daily hunger rating in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a visual analogue scale 'How hungry have you felt today?', scored from 0 (Generally not at all hungry) to 100 (Generally as hungry as I've ever felt).
Time Frame
every day of study diets (42days)
Title
Change in daily fullness rating in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a visual analogue scale 'How full have you felt today?', scored from 0 (Generally not at all full) to 100 (Generally as full as I've ever felt).
Time Frame
every day of study diets (42days)
Title
Change in daily desire to eat rating in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a visual analogue scale 'How strong has your desire to eat been today?', scored from 0 (Very weak) to 100 (Very strong).
Time Frame
every day of study diets (42days)
Title
Change in retrospective food consumption rating in response to dietary fibre and non-nutritive sweetener
Description
measured daily, at end of day, using questionnaires. Question presented as a visual analogue scale 'How much do you feel you could have eaten today?', scored from 0 (Nothing at all) to 100 (A large amount).
Time Frame
every day of study diets (42days)
Title
Change in appetite in response to dietary fibre and non-nutritive sweetener
Description
Mean of hunger, fullness, desire to eat and retrospective consumption ratings will be combined to report an overall appetite score (from 0 to 100)
Time Frame
every day of study diets (42days)
Title
Change in food intake
Description
measured using weighed intake records
Time Frame
at screening (7days) and every day of study diets (42days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Johnstone, Prof
Phone
01224 438614
Email
alex.johnstone@abdn.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Fyfe
Phone
01224 438752
Email
c.fyfe@abdn.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra Johnstone, Prof
Organizational Affiliation
Rowett Institute, University of Aberdeen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Ross, Dr
Organizational Affiliation
Rowett Institute, University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rowett Institute, University of Aberdeen
City
Aberdeen
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Johnstone, Prof
Phone
01224 438614
Email
alex.johnstone@abdn.ac.uk
First Name & Middle Initial & Last Name & Degree
Claire Fyfe, Ms
Phone
01224 438752
Email
c.fyfe@abdn.ac.uk
First Name & Middle Initial & Last Name & Degree
Alexandra Johnstone, Prof
First Name & Middle Initial & Last Name & Degree
Alexander Ross, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)
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