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Physiological Effects of Stevia Consumption in Humans

Primary Purpose

Glucose Intolerance, Obesity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
stevia
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Manchester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stevia arm

Control arm

Arm Description

stevia drops

No change in diet

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in body weight
body weight will be measured on visit week 0, visit week 6 and visit week 12
Change in dietary intake
participants will fill out 3 days of diet recalls before coming to all 3 study visits using Intake24
Change in waist circumference
waist circumference will be measured on visit week 0, visit week 6 and visit 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
Change in fasting blood glucose
Fasting blood glucose will be measured on visit week 0 and visit 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.

Full Information

First Posted
June 18, 2019
Last Updated
December 12, 2019
Sponsor
University of Manchester
Collaborators
Lancaster University
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1. Study Identification

Unique Protocol Identification Number
NCT03993418
Brief Title
Physiological Effects of Stevia Consumption in Humans
Official Title
Physiological Effects of Long-term Consumption of Non-nutritive Sweeteners in Humans: a Pilot 12 Week Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
Lancaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-group parallel 12-week intervention study with control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stevia arm
Arm Type
Experimental
Arm Description
stevia drops
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No change in diet
Intervention Type
Dietary Supplement
Intervention Name(s)
stevia
Intervention Description
This arm will be required to consume 5 stevia drops twice daily in habitual drinks
Primary Outcome Measure Information:
Title
Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC)
Description
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
Secondary Outcome Measure Information:
Title
Change in body weight
Description
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
Title
Change in dietary intake
Description
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
Title
Change in waist circumference
Description
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
Title
Change in appetite
Description
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
Title
Change in fasting blood glucose
Description
Fasting blood glucose will be measured on visit week 0 and visit week 12.
Time Frame
Week 0 and week 12
Title
Change in the 75-OGTT 2-hour blood glucose
Description
75g OGTT 2-h blood glucose will be measured on visit week 0 and visit week 12.
Time Frame
Week 0 and week 12
Other Pre-specified Outcome Measures:
Title
Physical activity
Description
Total MET-minutes per week measured via the International Physical Activity Questionnaire (IPAQ).
Time Frame
Week 0, visit week 6 and week 12
Title
Physical activity
Description
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
Title
Blood pressure
Description
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
Title
Composition of gut microbiome
Description
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
Title
Fasting plasma insulin
Description
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
Title
75g OGTT derived iAUC plasma insulin
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John McLaughlin
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manchester
City
Manchester
ZIP/Postal Code
M13 9PG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Physiological Effects of Stevia Consumption in Humans

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