Physiological Effects of Stevia Consumption in Humans

Obesity Clinical Trial

Official title:

Physiological Effects of Long-term Consumption of Non-nutritive Sweeteners in Humans: a Pilot 12 Week Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993418
• Other study ID #: 4812
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 10, 2019

Study information

• Verified date: December 2019
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 10, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 18-40 years

• BMI 18.5-25 kg/m2

• No or low NNS consumers (up to 1 can of diet soda per week or 1 sachet of NNS per week)

• DEBQ for restraint eating = 3

• Healthy - general good health

• Not taking medications that affect metabolism or appetite (i.e. thiazide diuretics, glucocorticoids or beta blockers)

• Stable weight, = 5 kg last 12 months

• Fasting blood glucose =6.0 mmol/L

• Willing to comply with the study protocol

• No self-reported food allergy or intolerance to foods supplied during the study

• The participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

• The participant is able to read, comprehend and record information written in English.

• A signed and dated written informed consent is obtained from the participant.

Exclusion Criteria:

• Age under 18 years or over 40 years old.

• BMI >25 kg/m2 and <18.5kg/m2

• Participants who are not willing to comply with study procedures (including expression of dislike for NNS)

• Habitual NNS consumers, >1 can of diet beverage or >1 sachet of low calorie sweeteners per week.

• Fasting blood glucose measured > 6 mmol/L

• Subjects who are currently dieting and having ceased a diet in < 4 weeks

• DEBQ score for restraint eating > 3

• Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Vegetarian Diet, Raw Food Diet etc.

• Vegetarians, vegans

• Subjects who take recreational substances such as cannabis.

• Presence of any chronic condition requiring medication that might affect our results (e.g. diabetes, mental diseases, gastrointestinal diseases)

• Subjects with eating disorders (binge eating disorder, bulimia etc)

• Subjects who are currently experiencing anxiety or depression

• Participants who drink alcohol more than the NHS guidelines (14 units per week)

• >10 h of vigorous physical activities per week and/or planning to increase/decrease physical activity levels in the next months.

• Having ceased smoking in the last six months

• Female participants who are, or may be, pregnant, or currently lactating.

• Subjects who regularly consume dietary supplements for weight loss, muscle building etc.

• Subjects with food allergies or intolerances related to the study.

• Subjects who have given blood elsewhere within the last month.

• The participant cannot read, comprehend and record information written in English.

Related Conditions & MeSH terms

• Glucose Intolerance
• Obesity

Intervention

Dietary Supplement:
• stevia
This arm will be required to consume 5 stevia drops twice daily in habitual drinks

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	Lancaster University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity	Total MET-minutes per week measured via the International Physical Activity Questionnaire (IPAQ).	Week 0, visit week 6 and week 12
Other	Physical activity	Number of steps per day. 3 days before visit week 0, visit week 6 and visit week 12	Week 0, week 6, week 12
Other	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
Other	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
Other	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
Other	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
Primary	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
Secondary	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
Secondary	Change in dietary intake	participants will fill out 3 days of diet recalls before coming to all 3 study visits using Intake24	Week 0, visit week 6 and week 12
Secondary	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
Secondary	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
Secondary	Change in fasting blood glucose	Fasting blood glucose will be measured on visit week 0 and visit week 12.	Week 0 and week 12
Secondary	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