OverweightNCT04335565
Stevia Extract and Glucose Homeostasis
A study testing sugar replacements in people with Overweight and Obesity, run by Liverpool Hope University at 1 site in United Kingdom.
Trial summary
This study aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- sugar replacements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2020to 15 Feb 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- BMI 27-40 Kg/m2
- Males and females
Who cannot join
- Athletes
- Pregnant or breastfeeding women
- Patients with chronic disease (diabetes, CVD etc…).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Health sciences, Liverpool Hope University
Liverpool, L16 9JD
About this study
Official title: Effect of Stevia Extract on Postprandial Glucose Response and Satiety in Overweight and Obese Adults: A Three-arm Crossover Trial.
This study aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water.
Read the detailed description
The study is a three-arm crossover trial involving participants attending the Lab on 3 different occasions (separated by 3-5 day washout period), where they will be administered water, sugar solution (65g), water and stevia extract (5g) solution. The solution will be followed by a consumption of a fixed meal (after 30 minutes). Breakfast will be standardised. Capillary blood glucose will be collected every 30 min until 2 hours post meal. Venous blood samples will be collected before the intake of the solution and at 2 hours after meal intake.
- Conditions
- Overweight, Obesity
- Being tested
- sugar replacements
- Keywords
- Non-nutritive sweeteners, postprandial glucose, diabetes, obesity, satiety
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sugar replacementsOther
Participants will receive a solution of stevia before being administered a fixed meal (lunch). Glucose and insulin levels, and Visual analogue scale data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Water | No intervention | 250 ml of water mixed with 1g of citric acid. |
| Sugar | Active comparator | 65g of sugar dissolved in 250ml of water Receives: Other: sugar replacements |
| Stevia | Experimental | 5g of stevia dissolved in 250ml of water Receives: Other: sugar replacements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial glucose levels
Change in glucose levels two hours after the administration of a fixed meal
Measured: Capillary blood glucose will be measured two hours after the administration of a fixed meal.
Secondary outcomes (3)
Postprandial insulin levels
Change in postprandial insulin levels two hours after the administration of a fixed meal
Measured: Postprandial insulin levels will be measured two hours of the administration of a fixed meal
Area under the curve (AUC) for glucose
Changes in AUC for glucose throughout the intervention
Measured: Capillary blood glucose levels will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch
Subjective feelings of satiety
Visual analogue scales
Measured: VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start3 Mar 2020
- Primary completion15 Feb 2021
- Study completion15 Feb 2021
Why it stopped: The study has been terminated due to the pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Hope University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Farhat, Liverpool Hope University
- Investigators
- Farzad Amirabdollahian, PhD, Study chair, Liverpool Hope University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335565
- Sponsor's protocol ID
- 13022020
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Farhat G, Berset V, Moore L. Effects of Stevia Extract on Postprandial Glucose Response, Satiety and Energy Intake: A Three-Arm Crossover Trial. Nutrients. 2019 Dec 12;11(12):3036. doi: 10.3390/nu11123036.
PubMed 31842388
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stevia Extract on Postprandial Glucose Response and Satiety in Overweight and Obese Adults: A Three-arm Crossover Trial.
- ClinicalTrials.gov ID
- NCT04335565
- Acronym / sponsor ID
- 13022020
- Conditions
- Overweight, Obesity
- Keywords
- Non-nutritive sweeteners, postprandial glucose, diabetes, obesity, satiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study has been terminated due to the pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liverpool Hope UniversityUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 6 Apr 2020 (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 aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water.
Detailed description
The study is a three-arm crossover trial involving participants attending the Lab on 3 different occasions (separated by 3-5 day washout period), where they will be administered water, sugar solution (65g), water and stevia extract (5g) solution. The solution will be followed by a consumption of a fixed meal (after 30 minutes). Breakfast will be standardised. Capillary blood glucose will be collected every 30 min until 2 hours post meal. Venous blood samples will be collected before the intake of the solution and at 2 hours after meal intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water | No intervention | –250 ml of water mixed with 1g of citric acid. |
| Sugar | Active comparator | Other: sugar replacements65g of sugar dissolved in 250ml of water |
| Stevia | Experimental | Other: sugar replacements5g of stevia dissolved in 250ml of water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- BMI 27-40 Kg/m2
- Males and females
Key exclusion criteria (3 listed)
- Athletes
- Pregnant or breastfeeding women
- Patients with chronic disease (diabetes, CVD etc…).
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 |
|---|---|---|
| sugar replacementsParticipants will receive a solution of stevia before being administered a fixed meal (lunch). Glucose and insulin levels, and Visual analogue scale data will be collected. | Other | Stevia, Sugar |
Primary outcome
Postprandial glucose levels
Time frame: Capillary blood glucose will be measured two hours after the administration of a fixed meal.
Change in glucose levels two hours after the administration of a fixed meal
3 secondary outcomes
Postprandial insulin levels
Time frame: Postprandial insulin levels will be measured two hours of the administration of a fixed meal
Area under the curve (AUC) for glucose
Time frame: Capillary blood glucose levels will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch
Subjective feelings of satiety
Time frame: VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 31842388Farhat G, Berset V, Moore L. Effects of Stevia Extract on Postprandial Glucose Response, Satiety and Energy Intake: A Three-Arm Crossover Trial. Nutrients. 2019 Dec 12;11(12):3036. doi: 10.3390/nu11123036.
- Individual participant dataSharing planned: No
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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.
Farzad Amirabdollahian, PhD study chair
Liverpool Hope University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sugar replacements in people with Overweight and Obesity, run by Liverpool Hope University 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 10 May 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Postprandial glucose levels (time frame: Capillary blood glucose will be measured two hours after the administration of a fixed meal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335565, which also lists 1 linked publication.
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 10 May 2021.