Glucose IntoleranceNCT03993418
Physiological Effects of Stevia Consumption in Humans
A study testing stevia in people with Glucose Intolerance and Obesity, run by University of Manchester at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance, Obesity
- What is being tested?
- stevia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Glucose Intolerance, Obesity
- Being tested
- stevia
- Medical subject headings
- Glucose Intolerance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
steviaDietary supplement
This arm will be required to consume 5 stevia drops twice daily in habitual drinks
| Study group | Role | What they receive |
|---|---|---|
| Stevia arm | Experimental | stevia drops Receives: Dietary Supplement: stevia |
| Control arm | No intervention | No change in diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 0 and week 12
Secondary outcomes (6)
Change in body weight
body weight will be measured on visit week 0, visit week 6 and visit week 12
Measured: 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
Measured: 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
Measured: 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
Measured: Week 0 and week 12
Change in fasting blood glucose
Fasting blood glucose will be measured on visit week 0 and visit week 12.
Measured: 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.
Measured: Week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Feb 2019
- Primary completion10 Dec 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-group parallel 12-week intervention study with control group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Lancaster University
- Responsible party
- Principal investigator, Nikoleta Stamataki, University of Manchester
- Investigators
- John McLaughlin, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993418
- Sponsor's protocol ID
- 4812
- Status last verified
- Dec 2019
- First submitted
- 18 Jun 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of Long-term Consumption of Non-nutritive Sweeteners in Humans: a Pilot 12 Week Randomised Trial
- ClinicalTrials.gov ID
- NCT03993418
- Acronym / sponsor ID
- 4812
- Conditions
- Glucose Intolerance, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Lancaster University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-group parallel 12-week intervention study with control group
| Arm | Type | Receives |
|---|---|---|
| Stevia arm | Experimental | Dietary Supplement: steviastevia drops |
| Control arm | No intervention | –No change in diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| steviaThis arm will be required to consume 5 stevia drops twice daily in habitual drinks | Dietary supplement | Stevia arm |
Primary outcome
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
6 secondary outcomes
Change in body weight
Time frame: Week 0, visit week 6 and week 12
Change in dietary intake
Time frame: Week 0, visit week 6 and week 12
Change in waist circumference
Time frame: Week 0, visit week 6 and week 12
Change in appetite
Time frame: Week 0 and week 12
Change in fasting blood glucose
Time frame: Week 0 and week 12
Change in the 75-OGTT 2-hour blood glucose
Time frame: Week 0 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John McLaughlin principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stevia in people with Glucose Intolerance and Obesity, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose response to an oral glucose tolerance test (OGTT) measured as incremental area under the curve (iAUC) (time frame: Week 0 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.