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| Name | Class |
|---|---|
| Lancaster University | OTHER |
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This study will evaluate whether long-term consumption of the low calorie sweetener stevia affects glucose tolerance in healthy participants. With regard to this aim, we will recruit 2 study groups, the stevia group where participants will be required to add stevia drops twice daily in their habitual drinks and the control group where participants will be asked not to change anything in their diet and lifestyle.
Excess consumption of caloric sweeteners contributes to the alarming rates of overweight and obesity, whereas non-nutritive sweeteners (NNS) are non-caloric alternatives offering sensory and health benefits. NNS are widely used to moderate energy intake and postprandial glycaemia, but there is controversial evidence about their role and effects. Stevia, a natural NNS, has been suggested to assist with glucose regulation but data on glucose tolerance after daily consumption of stevia are lacking. The investigators plan to undertake a pilot randomized 2-parallel arm open-label 12-week trial, where participants will start consuming stevia with their habitual drinks. Thirty healthy volunteers (not habitual consumers of stevia or other NNS) will be recruited. The intervention group (n=15) will consume 5 drops of stevia with their habitual drinks twice daily whereas the control group (n=15) will not be required to change anything in their diet, but avoid consuming NNS or diet beverages for the study duration.
Key measures in glucose homeostasis including glucose response to an oral glucose tolerance test will be performed before and after the intervention period. Serum and plasma samples will be stored for potential analysis of insulin and gut hormones levels.
Participants will have to attend 3 study visits, visit week 0, visit week 6 and visit week 12, but the primary outcome will be assessed in visit week 0 and visit week 12.
Participants will be weighed; dietary intake, physical activity and appetite will be also assessed. Faecal samples will be collected and gut microbiome analysis may be performed. Gut microbiome has been considered to be a key linked topic, since it has been suggested that saccharin consumption may induce glucose intolerance in humans through alterations in gut microbiota in humans.
The trial will assess whether regular use of stevia in realistic amounts has any effects on glucose homeostasis, and aims to elucidate our understanding of long-term physiological effects of NNS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stevia arm | Experimental | stevia drops |
|
| Control arm | No Intervention | No change in diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stevia | Dietary Supplement | This arm will be required to consume 5 stevia drops twice daily in habitual drinks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC) | blood glucose levels will be measured at baseline (0) and at 15, 30, 45, 60, 90 and 120 min after the consumption of a 75 g glucose load and iAUC will be calculated | Week 0 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | body weight will be measured on visit week 0, visit week 6 and visit week 12 | Week 0, visit week 6 and week 12 |
| Change in dietary intake | participants will fill out 3 days of diet recalls before coming to all 3 study visits using Intake24 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Total MET-minutes per week measured via the International Physical Activity Questionnaire (IPAQ). | Week 0, visit week 6 and week 12 |
| Physical activity | Number of steps per day. 3 days before visit week 0, visit week 6 and visit week 12 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McLaughlin | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manchester | Manchester | M13 9PG | United Kingdom |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C012043 | stevioside |
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2-group parallel 12-week intervention study with control group
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| Week 0, visit week 6 and week 12 |
| Change in waist circumference | waist circumference will be measured on visit week 0, visit week 6 and visit week 12 | Week 0, visit week 6 and week 12 |
| Change in appetite | Appetite questionnaires (three factor eating questionnaire, sweet food frequency questionnaire, Satiety, hunger, and food cravings - using the Control of Eating Questionnaire ) will be completed on visit week 0 and visit week 12 | Week 0 and week 12 |
| Change in fasting blood glucose | Fasting blood glucose will be measured on visit week 0 and visit week 12. | Week 0 and week 12 |
| Change in the 75-OGTT 2-hour blood glucose | 75g OGTT 2-h blood glucose will be measured on visit week 0 and visit week 12. | Week 0 and week 12 |
| Week 0, week 6, week 12 |
| Blood pressure | Blood pressure will be measure on visit week 0, visit week 6 and visit week 12 | Week 0, visit week 6 and week 12 |
| Composition of gut microbiome | Changes in gut microbiota will be measured by 16S rRNA gene sequencing. This outcome is optional and will be decided by the investigators based on the findings in the primary outcome. | Week 0 and week 12 |
| Fasting plasma insulin | This outcome is optional and will be decided by the investigators based on the findings in the primary outcome | Week 0 and week 12 |
| 75g OGTT derived iAUC plasma insulin | This outcome is optional and will be decided by the investigators based on the findings in the primary outcome. | Week 0 and week 12 |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |