Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-28 @ 3:56 PM
Study NCT ID:
NCT05892003
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2023-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001070', 'term': 'Appetitive Behavior'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2023-05-17', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in concentration of blood metabolites in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At baseline and end of each arm (study days 1, 15, 29 and 43)', 'description': 'measured by changes in fasted plasma short chain fatty acid (SCFA) concentrations'}, {'measure': 'Change in concentration of gut hormones in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At baseline and end of each arm (study days 1, 15, 29 and 43)', 'description': 'measured by changes in fasted plasma ghrelin, GLP-1 and peptide YY (PYY) concentrations'}, {'measure': 'Change in lipid profile in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At baseline and end of each arm (study days 1, 15, 29 and 43)', 'description': 'measured by changes in fasted plasma lipid profile (Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and non-esterified fatty acids (NEFA)'}, {'measure': 'Change in lipid ratios in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At baseline and end of each arm (study days 1, 15, 29 and 43)', 'description': 'Total cholesterol, HDL-cholesterol and LDL-cholesterol measures will be combined to report TC to HDL and LDL to HDL ratios.'}, {'measure': 'Change in concentration of urinary metabolites in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At baseline and end of each arm (study days 1, 15, 29 and 43)', 'description': 'changes in urinary metabolite concentrations measured by metabolomics'}, {'measure': 'Height', 'timeFrame': 'At screening visit only', 'description': 'measured in metres'}, {'measure': 'Change in body weight in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At screening and 3 times a week on each arm (20 occasions from date of screening up to study day 43)', 'description': 'measured as weight in kilograms'}, {'measure': 'Change in Body Mass Index (BMI) in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At screening and 3 times a week on each arm (20 occasions from date of screening up to study day 43)', 'description': 'weight and height measures will be combined to report BMI in kg/m\\^2'}, {'measure': 'Change in daily nausea symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily bloating symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily flatulence symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily abdominal cramp symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily intestinal rumble symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily diarrhoea symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily constipation symptoms in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily bowel movements in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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."}, {'measure': 'Change in daily hunger rating in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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)."}, {'measure': 'Change in daily fullness rating in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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)."}, {'measure': 'Change in daily desire to eat rating in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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)."}, {'measure': 'Change in retrospective food consumption rating in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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)."}, {'measure': 'Change in appetite in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', '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)'}, {'measure': 'Change in food intake', 'timeFrame': 'at screening (7days) and every day of study diets (42days)', 'description': 'measured using weighed intake records'}], 'primaryOutcomes': [{'measure': '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)', 'description': 'Measured by changes in faecal short chain fatty acids concentrations'}, {'measure': '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)', 'description': 'Measured by changes in bacterial 16S ribosomal ribonucleic acid gene sequencing; 16S rRNA'}, {'measure': '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)', 'description': 'Measured by changes in calprotectin concentrations'}], 'secondaryOutcomes': [{'measure': 'Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'every day of study diets (42days)', 'description': 'measured using continuous glucose monitoring (CGM)'}, {'measure': 'Change in glycaemic control in response to dietary fibre and non-nutritive sweetener', 'timeFrame': 'At baseline and end of each arm (study days 1, 15, 29 and 43)', 'description': 'measured by changes in fasted plasma glucose and insulin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fibre', 'non-nutritive sweetener', 'weight loss', 'gut microbiome', 'glycaemic control'], 'conditions': ['Appetitive Behavior']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy but overweight/obese (BMI 28-40kg/m2) males and females (postmenopausal, using the oral contraceptive pill or some form of hormonal contraceptive)\n* moderate habitual fibre intake (18-23g/day)\n\nExclusion Criteria:\n\nMedication exclusion criteria:\n\n* antibiotic use (within the past 3 months due to impact on gut microbiota)\n* anti-depressants (current)\n* smoking or vaping\n* weight loss medication\n\nMedical exclusion criteria:\n\n* Females who are planning to be pregnant, are pregnant or are breastfeeding\n* Anyone with food allergies, self-reported food sensitivity or intolerance\n* Anyone with coeliac disease or gluten intolerance\n* Anyone taking medication which may affect their appetite\n* Anyone with an eating disorder\n* Anyone with diabetes\n* Anyone with a gastrointestinal disorder, kidney disease, liver disease or gout\n* Anyone suffering from a psychiatric disorder or any type of substance abuse\n* Anyone suffering from unregulated thyroid disease\n\nOther exclusion criteria:\n\n* Anyone following a vegetarian or vegan diet\n* Anyone following a current weight loss programme (that may be affecting lifestyle, physical activity \\& diet) or undergone gastric band/reduction surgery\n* Anyone with unsuitable veins for blood sampling\n* Anyone who is unable to fluently speak, read and understand English\n* Anyone who is unable to comply to an alcohol-free diet for 6 weeks\n\nCurrent 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.'}, 'identificationModule': {'nctId': 'NCT05892003', 'acronym': 'SSS', 'briefTitle': 'Scot Sweet Study (Interaction of a Non-nutritive Sweetener With a High-fibre Weight Loss Diet)', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Healthy Diets for a Healthy Weight: Exploring Physiological Mechanisms Related to Dietary Fibre and Non-Nutritive Sweeteners', 'orgStudyIdInfo': {'id': '814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL', 'description': '* Phase 1 CTRL: Control diet with moderate fibre consumption for 14days.\n* Phase 2 HF WL: High Fibre Weight Loss meal consumption for 14days.\n* Phase 3 HF-NNS WL: High Fibre and Non-Nutritive Sweetener Weight Loss meal consumption for 14days.', 'interventionNames': ['Other: Phase 1 Control', 'Other: Phase 2 High Fibre Weight Loss', 'Other: Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss']}], 'interventions': [{'name': 'Phase 1 Control', 'type': 'OTHER', 'otherNames': ['CTRL'], '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).', 'armGroupLabels': ['Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL']}, {'name': 'Phase 2 High Fibre Weight Loss', 'type': 'OTHER', 'otherNames': ['HF WL'], '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.', 'armGroupLabels': ['Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL']}, {'name': 'Phase 3 High Fibre and Non-Nutritive Sweetener Weight Loss', 'type': 'OTHER', 'otherNames': ['HF-NNS WL'], '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.', 'armGroupLabels': ['Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZD', 'city': 'Aberdeen', 'country': 'United Kingdom', 'facility': 'Rowett Institute, University of Aberdeen', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}], 'overallOfficials': [{'name': 'Alexandra Johnstone, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rowett Institute, University of Aberdeen'}, {'name': 'Alexander Ross, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rowett Institute, University of Aberdeen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}