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出境医 / 临床实验 / Physiological Effects of Stevia Consumption in Humans

Physiological Effects of Stevia Consumption in Humans

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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Obesity Dietary Supplement: stevia Not Applicable

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2-group parallel 12-week intervention study with control group
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Physiological Effects of Long-term Consumption of Non-nutritive Sweeteners in Humans: a Pilot 12 Week Randomised Trial
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 10, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Stevia arm
stevia drops
Dietary Supplement: stevia
This arm will be required to consume 5 stevia drops twice daily in habitual drinks

No Intervention: Control arm
No change in diet
Outcome Measures
Primary Outcome Measures :
  1. Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC) [ Time Frame: Week 0 and week 12 ]
    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 :
  1. Change in body weight [ Time Frame: Week 0, visit week 6 and week 12 ]
    body weight will be measured on visit week 0, visit week 6 and visit week 12

  2. Change in dietary intake [ Time Frame: Week 0, visit week 6 and week 12 ]
    participants will fill out 3 days of diet recalls before coming to all 3 study visits using Intake24

  3. Change in waist circumference [ Time Frame: Week 0, visit week 6 and week 12 ]
    waist circumference will be measured on visit week 0, visit week 6 and visit week 12

  4. Change in appetite [ Time Frame: Week 0 and week 12 ]
    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

  5. Change in fasting blood glucose [ Time Frame: Week 0 and week 12 ]
    Fasting blood glucose will be measured on visit week 0 and visit week 12.

  6. Change in the 75-OGTT 2-hour blood glucose [ Time Frame: Week 0 and week 12 ]
    75g OGTT 2-h blood glucose will be measured on visit week 0 and visit week 12.


Other Outcome Measures:
  1. Physical activity [ Time Frame: Week 0, visit week 6 and week 12 ]
    Total MET-minutes per week measured via the International Physical Activity Questionnaire (IPAQ).

  2. Physical activity [ Time Frame: Week 0, week 6, week 12 ]
    Number of steps per day. 3 days before visit week 0, visit week 6 and visit week 12

  3. Blood pressure [ Time Frame: Week 0, visit week 6 and week 12 ]
    Blood pressure will be measure on visit week 0, visit week 6 and visit week 12

  4. Composition of gut microbiome [ Time Frame: Week 0 and week 12 ]
    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.

  5. Fasting plasma insulin [ Time Frame: Week 0 and week 12 ]
    This outcome is optional and will be decided by the investigators based on the findings in the primary outcome

  6. 75g OGTT derived iAUC plasma insulin [ Time Frame: Week 0 and week 12 ]
    This outcome is optional and will be decided by the investigators based on the findings in the primary outcome.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Locations
Layout table for location information
United Kingdom
University of Manchester
Manchester, United Kingdom, M13 9PG
Sponsors and Collaborators
University of Manchester
Lancaster University
Investigators
Layout table for investigator information
Principal Investigator: John McLaughlin University of Manchester
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 20, 2019
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE February 1, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC) [ Time Frame: Week 0 and week 12 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Change in body weight [ Time Frame: Week 0, visit week 6 and week 12 ]
    body weight will be measured on visit week 0, visit week 6 and visit week 12
  • Change in dietary intake [ Time Frame: Week 0, visit week 6 and week 12 ]
    participants will fill out 3 days of diet recalls before coming to all 3 study visits using Intake24
  • Change in waist circumference [ Time Frame: Week 0, visit week 6 and week 12 ]
    waist circumference will be measured on visit week 0, visit week 6 and visit week 12
  • Change in appetite [ Time Frame: Week 0 and week 12 ]
    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 [ Time Frame: Week 0 and week 12 ]
    Fasting blood glucose will be measured on visit week 0 and visit week 12.
  • Change in the 75-OGTT 2-hour blood glucose [ Time Frame: Week 0 and week 12 ]
    75g OGTT 2-h blood glucose will be measured on visit week 0 and visit week 12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 22, 2019)
  • Physical activity [ Time Frame: Week 0, visit week 6 and week 12 ]
    Total MET-minutes per week measured via the International Physical Activity Questionnaire (IPAQ).
  • Physical activity [ Time Frame: Week 0, week 6, week 12 ]
    Number of steps per day. 3 days before visit week 0, visit week 6 and visit week 12
  • Blood pressure [ Time Frame: Week 0, visit week 6 and week 12 ]
    Blood pressure will be measure on visit week 0, visit week 6 and visit week 12
  • Composition of gut microbiome [ Time Frame: Week 0 and week 12 ]
    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.
  • Fasting plasma insulin [ Time Frame: Week 0 and week 12 ]
    This outcome is optional and will be decided by the investigators based on the findings in the primary outcome
  • 75g OGTT derived iAUC plasma insulin [ Time Frame: Week 0 and week 12 ]
    This outcome is optional and will be decided by the investigators based on the findings in the primary outcome.
Original Other Pre-specified Outcome Measures
 (submitted: June 18, 2019)
  • Physical activity [ Time Frame: Week 0, visit week 6 and week 12 ]
    monitoring with IPAQ, and pedometer app downloaded in participants smartphones
  • Blood pressure [ Time Frame: Week 0, visit week 6 and week 12 ]
    Blood pressure will be measure on visit week 0, visit week 6 and visit week 12
  • Composition of gut microbiome [ Time Frame: Week 0 and week 12 ]
    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.
  • Fasting plasma insulin [ Time Frame: Week 0 and week 12 ]
    This outcome is optional and will be decided by the investigators based on the findings in the primary outcome
  • 75g OGTT derived iAUC plasma insulin [ Time Frame: Week 0 and week 12 ]
    This outcome is optional and will be decided by the investigators based on the findings in the primary outcome.
 
Descriptive Information
Brief Title  ICMJE Physiological Effects of Stevia Consumption in Humans
Official Title  ICMJE Physiological Effects of Long-term Consumption of Non-nutritive Sweeteners in Humans: a Pilot 12 Week Randomised Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2-group parallel 12-week intervention study with control group
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Glucose Intolerance
  • Obesity
Intervention  ICMJE Dietary Supplement: stevia
This arm will be required to consume 5 stevia drops twice daily in habitual drinks
Study Arms  ICMJE
  • Experimental: Stevia arm
    stevia drops
    Intervention: Dietary Supplement: stevia
  • No Intervention: Control arm
    No change in diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 10, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03993418
Other Study ID Numbers  ICMJE 4812
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nikoleta Stamataki, University of Manchester
Study Sponsor  ICMJE University of Manchester
Collaborators  ICMJE Lancaster University
Investigators  ICMJE
Principal Investigator: John McLaughlin University of Manchester
PRS Account University of Manchester
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP