AppetiteNCT07018921
Low Calorie Sweeteners Effects on Appetite
A study testing rebaudioside A in people with Appetite, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The principal research question is whether the ingestion of stevia (rebaudioside A) in encapsulated format will have any effects on blood glucose, appetite and food intake in healthy human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetite
- What is being tested?
- rebaudioside A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Mar 2023to 31 Dec 2023
- 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 between 18.5-24.9 kg/m2
- DEBQ for restraint eating ≤ 3
- Healthy - general good health
- Currently not taking any medication (other than females taking the oral contraceptives, or medication that does not affect taste, and glucose response)
- Regular breakfast eaters (≥5 times per week)
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- Stable weight, ≤ 5 kg last 3 months
- 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
- Subjects who are currently on a diet
- Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Raw Food Diet etc.
- Vegetarians, vegans
- Subjects having breakfast fewer than 5 times per week.
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- 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 more than the NHS guidelines (14 units per week)
- Participants who are, or may be, pregnant, or currently lactating.
- Subjects who regularly consume dietary supplements for weight loss, muscle building etc.
- Subjects who have aversions to foods related with the study.
- Subjects with food allergies or intolerance related with the foods/ drinks of the study.
- Habitual NNS consumers, >1 can of diet beverage or >1 sachet of low calorie sweeteners (corresponding to 1 spoonful) per week.
- 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: Do Sweeteners Need to be Tasted to Affect Appetite? A Pilot Study
The principal research question is whether the ingestion of stevia (rebaudioside A) in encapsulated format will have any effects on blood glucose, appetite and food intake in healthy human volunteers.
Read the detailed description
Obesity presents a major global health crisis; developing healthier diets is a key goal. Excess consumption of caloric sweeteners contributes to the alarming high rates of overweight and obesity. Non-nutritive sweeteners, like stevia, are used to decrease energy content of foods and beverages. Very recently a systematic review and meta-analysis conducted and published by WHO, concluded that non-nutritive sweeteners use results in small reduction in body weight and BMI in adults, as assessed in RCTs.
In a previous set of studies from our group we showed that a single-dose of a stevia-sweetened beverage prior to lunch leads a lower energy intake compared to consuming water or a sugar-sweetened beverage (Stamataki et al J Nutr. 2020; 150(5):1126-1134. doi: 10.1093/jn/nxaa038). This effect was confirmed to be present in the long-term, as in another 12-weeks trial we demonstrated that individuals in the stevia group (they started consuming stevia drops twice daily with habitual drinks before their meals) demonstrated a significant spontaneous reduction in energy intake compared to the control group (Stamataki et al Nutrients. 2020;12(10):3049. doi: 10.3390/nu12103049).
In a nutshell, this research so far has showed that stevia consumption elicits benefits in appetite and energy intake, without affecting physiological responses such as postprandial glucose response. Taking this research a step further, it is crucial now to answer whether sweetness without calories was the key component of these outcomes, in other words would stevia have the same effects if it was not tasted, if sweet taste (in the oral cavity) was bypassed?
As such the main aim of this study is to evaluate the effects of stevia in a capsule vs placebo on appetite and energy intake and elucidate whether stevia elicits similar effects when sweet taste is bypassed.
- Conditions
- Appetite
- Being tested
- rebaudioside A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rebaudioside ADietary supplement
rebaudioside A encapsulated in a vegetarian capsule
PlaceboDietary supplement
carboxymethylcellulose encapsulated in a vegetarian capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will attend 2 testing sessions, where they will consume either the stevia capsule or the placebo capsule in a double-blind randomised crossover design. Receives: Dietary Supplement: rebaudioside A; Dietary Supplement: Placebo |
| rebaudioside A | Active comparator | Participants will attend 2 testing sessions, where they will consume either the stevia capsule or the placebo capsule in a double-blind randomised crossover design. Receives: Dietary Supplement: rebaudioside A; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Participants are allowed to eat from a buffet lunch until they feel comfortably full.
Measured: Lunch at 30 min after the ingestion of the treatment
Secondary outcomes (2)
Appetite ratings
Using VAS scales for appetite, participants rate their appetite at baseline (before ingestion of the capsule), 15, 30 min after the ingestion of the capsule as well as at 60 min (which also corresponds 30 min after the start of the ad libitum meal).
Measured: 0, 15, 30 and 60 min
Blood glucose
Capillary blood glucose measurements will be conducted at baseline (0), 15 min and 30 min following treatment as well as at 60 min after the ingestion of the capsule which also corresponds 30 min after the consumption of the ad libitum lunch.
Measured: 0, 15, 30 and 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Mar 2023
- Primary completion19 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppetiteStudies 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
- Single group
- Model description
- This study is double blind. All participants are completing 2 testing sessions in randomised and counterbalanced order. Participants and researchers (who are also outcome assessors) are blinded to the beverages content. Un-blinding will be performed following analysis of results.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikoleta Stamataki, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018921
- Sponsor's protocol ID
- 2022-15284-25905
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Sweeteners Need to be Tasted to Affect Appetite? A Pilot Study
- ClinicalTrials.gov ID
- NCT07018921
- Acronym / sponsor ID
- 2022-15284-25905
- Conditions
- Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Jun 2025 (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.
The principal research question is whether the ingestion of stevia (rebaudioside A) in encapsulated format will have any effects on blood glucose, appetite and food intake in healthy human volunteers.
Detailed description
Obesity presents a major global health crisis; developing healthier diets is a key goal. Excess consumption of caloric sweeteners contributes to the alarming high rates of overweight and obesity. Non-nutritive sweeteners, like stevia, are used to decrease energy content of foods and beverages. Very recently a systematic review and meta-analysis conducted and published by WHO, concluded that non-nutritive sweeteners use results in small reduction in body weight and BMI in adults, as assessed in RCTs.
In a previous set of studies from our group we showed that a single-dose of a stevia-sweetened beverage prior to lunch leads a lower energy intake compared to consuming water or a sugar-sweetened beverage (Stamataki et al J Nutr. 2020; 150(5):1126-1134. doi: 10.1093/jn/nxaa038). This effect was confirmed to be present in the long-term, as in another 12-weeks trial we demonstrated that individuals in the stevia group (they started consuming stevia drops twice daily with habitual drinks before their meals) demonstrated a significant spontaneous reduction in energy intake compared to the control group (Stamataki et al Nutrients. 2020;12(10):3049. doi: 10.3390/nu12103049).
In a nutshell, this research so far has showed that stevia consumption elicits benefits in appetite and energy intake, without affecting physiological responses such as postprandial glucose response. Taking this research a step further, it is crucial now to answer whether sweetness without calories was the key component of these outcomes, in other words would stevia have the same effects if it was not tasted, if sweet taste (in the oral cavity) was bypassed?
As such the main aim of this study is to evaluate the effects of stevia in a capsule vs placebo on appetite and energy intake and elucidate whether stevia elicits similar effects when sweet taste is bypassed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is double blind. All participants are completing 2 testing sessions in randomised and counterbalanced order. Participants and researchers (who are also outcome assessors) are blinded to the beverages content. Un-blinding will be performed following analysis of results.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: rebaudioside A, Dietary Supplement: PlaceboParticipants will attend 2 testing sessions, where they will consume either the stevia capsule or the placebo capsule in a double-blind randomised crossover design. |
| rebaudioside A | Active comparator | Dietary Supplement: rebaudioside A, Dietary Supplement: PlaceboParticipants will attend 2 testing sessions, where they will consume either the stevia capsule or the placebo capsule in a double-blind randomised crossover design. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18 - 40 years
- BMI between 18.5-24.9 kg/m2
- DEBQ for restraint eating ≤ 3
- Healthy - general good health
- Currently not taking any medication (other than females taking the oral contraceptives, or medication that does not affect taste, and glucose response)
Key exclusion criteria (16 listed)
- Age under 18 years or over 40 years old.
- BMI ≥25 kg/m2 and <18.5kg/m2
- Subjects who are currently on a diet
- Subjects who follow special diets for weight maintenance, such as Atkins Diet, Weight Watchers, gluten-free diet, The Zone diet, Raw Food Diet etc.
- Vegetarians, vegans
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 |
|---|---|---|
| rebaudioside Arebaudioside A encapsulated in a vegetarian capsule | Dietary supplement | Placebo, rebaudioside A |
| Placebocarboxymethylcellulose encapsulated in a vegetarian capsule | Dietary supplement | Placebo, rebaudioside A |
Primary outcome
Energy intake
Time frame: Lunch at 30 min after the ingestion of the treatment
Participants are allowed to eat from a buffet lunch until they feel comfortably full.
2 secondary outcomes
Appetite ratings
Time frame: 0, 15, 30 and 60 min
Blood glucose
Time frame: 0, 15, 30 and 60 min
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 Jun 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rebaudioside A in people with Appetite, 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 11 inclusion and 16 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 Jun 2025. 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. Some participants in this study may receive a placebo. 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?
Energy intake (time frame: Lunch at 30 min after the ingestion of the treatment). 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 Jun 2025.