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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control-High Fibre Weight Loss-High Fibre Non-Nutritive Sweetener Weight Loss: CTRL-HF WL-HF-NNS WL | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in free-living glycaemic control in response to dietary fibre and non-nutritive sweetener | measured using continuous glucose monitoring (CGM) | every day of study diets (42days) |
| Change in glycaemic control in response to dietary fibre and non-nutritive sweetener |
| Measure | Description | Time Frame |
|---|---|---|
| Change in concentration of blood metabolites in response to dietary fibre and non-nutritive sweetener | measured by changes in fasted plasma short chain fatty acid (SCFA) concentrations | 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 |
Inclusion Criteria:
Exclusion Criteria:
Medication exclusion criteria:
Medical exclusion criteria:
Other exclusion criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Johnstone, Prof | Rowett Institute, University of Aberdeen | Principal Investigator |
| Alexander Ross, Dr | Rowett Institute, University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rowett Institute, University of Aberdeen | Aberdeen | AB25 2ZD | United Kingdom |
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| ID | Term |
|---|---|
| D001070 | Appetitive Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001522 | Behavior, Animal |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| 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. |
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| 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. |
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measured by changes in fasted plasma glucose and insulin |
| At baseline and end of each arm (study days 1, 15, 29 and 43) |
measured by changes in fasted plasma ghrelin, GLP-1 and peptide YY (PYY) concentrations |
| 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 | measured by changes in fasted plasma lipid profile (Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and non-esterified fatty acids (NEFA) | At baseline and end of each arm (study days 1, 15, 29 and 43) |
| Change in lipid ratios in response to dietary fibre and non-nutritive sweetener | Total cholesterol, HDL-cholesterol and LDL-cholesterol measures will be combined to report TC to HDL and LDL to HDL ratios. | At baseline and end of each arm (study days 1, 15, 29 and 43) |
| Change in concentration of urinary metabolites in response to dietary fibre and non-nutritive sweetener | changes in urinary metabolite concentrations measured by metabolomics | At baseline and end of each arm (study days 1, 15, 29 and 43) |
| Height | measured in metres | At screening visit only |
| Change in body weight in response to dietary fibre and non-nutritive sweetener | measured as weight in kilograms | At screening and 3 times a week on each arm (20 occasions from date of screening up to study day 43) |
| Change in Body Mass Index (BMI) in response to dietary fibre and non-nutritive sweetener | weight and height measures will be combined to report BMI in kg/m^2 | At screening and 3 times a week on each arm (20 occasions from date of screening up to study day 43) |
| Change in daily nausea symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily bloating symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily flatulence symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily abdominal cramp symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily intestinal rumble symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily diarrhoea symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily constipation symptoms in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily bowel movements in response to dietary fibre and non-nutritive sweetener | 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. | every day of study diets (42days) |
| Change in daily hunger rating in response to dietary fibre and non-nutritive sweetener | 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). | every day of study diets (42days) |
| Change in daily fullness rating in response to dietary fibre and non-nutritive sweetener | 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). | every day of study diets (42days) |
| Change in daily desire to eat rating in response to dietary fibre and non-nutritive sweetener | 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). | every day of study diets (42days) |
| Change in retrospective food consumption rating in response to dietary fibre and non-nutritive sweetener | 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). | every day of study diets (42days) |
| Change in appetite in response to dietary fibre and non-nutritive sweetener | Mean of hunger, fullness, desire to eat and retrospective consumption ratings will be combined to report an overall appetite score (from 0 to 100) | every day of study diets (42days) |
| Change in food intake | measured using weighed intake records | at screening (7days) and every day of study diets (42days) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |