Physiological Effects of Stevia Consumption in Humans

December 12, 2019 updated by: Nikoleta Stamataki, University of Manchester

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Manchester, United Kingdom, M13 9PG
        • University of Manchester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Week 0 and week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Week 0, visit week 6 and 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
Week 0, visit week 6 and week 12
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
Week 0, visit week 6 and 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
Week 0 and 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.
Week 0 and 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.
Week 0 and week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Week 0, visit week 6 and week 12
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
Week 0, week 6, 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
Week 0, visit week 6 and 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.
Week 0 and week 12
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
Week 0 and week 12
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.
Week 0 and week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manchester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lancaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John McLaughlin, University of Manchester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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