An interventional study of stevia in Glucose Intolerance and Obesity, sponsored by University of Manchester. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-13.
Sponsored by University of Manchester · Not applicable, Interventional, and Basic science
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.
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
stevia drops
Dietary Supplement: stevia
No change in diet
This arm will be required to consume 5 stevia drops twice daily in habitual drinks
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
Time frame: Week 0 and week 12
Change in body weight
body weight will be measured on visit week 0, visit week 6 and visit week 12
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 0 and week 12
Change in fasting blood glucose
Fasting blood glucose will be measured on visit week 0 and visit week 12.
Time frame: 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.
Time frame: Week 0 and week 12
Physical activity
Total MET-minutes per week measured via the International Physical Activity Questionnaire (IPAQ).
Time frame: 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
Time frame: Week 0, week 6, week 12
Blood pressure
Blood pressure will be measure on visit week 0, visit week 6 and visit week 12
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Week 0 and week 12
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University of Manchester