ObesityNCT03711084
Effects of Sweetness on Neurocognitive Responses, Glycemia and Food Intake
A study testing Natural high potency sweetener from leaf extract, Glucose and Sucrose in people with Obesity, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This study aims to examine potential differences in neurocognitive responses to food-related cues, physiological and appetite responses as well as subsequent energy intake following the consumption of preloads differing in sweetness and/ or postprandial metabolic effects in healthy normal weight subjects. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Natural high potency sweetener from leaf extract, Glucose and Sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Apr 2018to 15 Nov 2018
- 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)
- Normal or corrected vision
Show all 13Show fewer
- Regular breakfast eaters (≥5 times per week)
- Stable weight, ≤ 5 kg last 12 months
- Fasting blood glucose ≤6.0 mmol/L
- 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, Vegetarian Diet, Raw Food Diet etc.
- Subjects having breakfast fewer than 5 times per week.
- Vegetarians, vegans.
Show all 18Show fewer
- 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.
- Subjects who do not have normal vision and do not correct it with glasses or contact lenses.
- Participants who drink more than the NHS guidelines (14 units per week)
- Female 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 table packet of sweeteners per week.
- Fasting blood glucose measured > 6 mmol/L at screening visit, according to diabetes.co.uk recommendations.
- 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: The Impact of Dietary Sweetness on Neurocognitive Responses to Visual Food Cues, Appetite and Physiological Parameters on Normal Weight Adults: a Pilot Study
This study aims to examine potential differences in neurocognitive responses to food-related cues, physiological and appetite responses as well as subsequent energy intake following the consumption of preloads differing in sweetness and/ or postprandial metabolic effects in healthy normal weight subjects.
Read the detailed description
Excess consumption of caloric sweeteners, together with the high availability of palatable food cues are some of the factors for the alarming high rates of overweight and obesity. Although non-nutritive sweeteners (NNS) are used to decrease energy content of foods and beverages, there is an on-going debate on the relationship between NNS intake, obesity and cardiometabolic risk. Caloric sugars have a differing effect on physiological responses compared to NNS. However it is almost wholly unknown how NNS consumption affects eating behaviour and cognitive processes.
This study compares the performance on food related neurocognitive tasks following the consumption of the test preloads on 5 visits. In particular, sucrose, glucose, maltodextrin, water or a natural high potency sweetener from leaf extract will be ingested as single test agents in randomized order. Water will be used as a control for gastric distension and non-sweet, whereas maltodextrin will be used as a non-sweet control for carbohydrate content.
Participants will be asked to attend a screening visit at the Neuroscience and Psychiatry Unit of the University of Manchester on a morning after overnight fast. Participants' weight and height, fasting blood glucose and blood pressure will be measured. This will be followed by some questionnaires regarding general health status, weight and dieting history and eating behaviour.
Participants who satisfy the inclusion criteria, will be then invited to take part in the full study. This will require 5 separate visits at the University of Manchester, which will be scheduled between 11.30 and 13.30. Participants will have to attend these visits after having fasted for 3-4 hours and will be asked to have their regular breakfast in the morning before the testing session, and then not eat or drink anything else for 3-4 hours until they come in the lab for the testing session. Water will be allowed up to 1 hour prior to your testing session. Prior to each testing session participants will be asked to have the same breakfast, and they will have to provide a picture of the breakfast each time to ensure compliance.
The 5 visits correspond to 5 test beverages, both the participants and the investigators are blinded to the study treatments. Blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will also be asked to rate their feeling of hunger, fullness etc using visual analogue scales (VAS) at the same time points 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks. They are designed to capture behaviour in response to food cue presentation. This will last approximately 15 min.
Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. Each session is anticipated to last for approximately 1 hour.
- Conditions
- Obesity
- Being tested
- Natural high potency sweetener from leaf extract, Glucose, Sucrose, Maltodextrin, Water
- Keywords
- non-nutritive sweeteners, sucrose, food-cue responses, appetite, blood glucose, energy intake
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural high potency sweetener from leaf extractDietary supplement
Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
GlucoseDietary supplement
Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
SucroseDietary supplement
Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
MaltodextrinDietary supplement
Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
WaterDietary supplement
Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full.
| Study group | Role | What they receive |
|---|---|---|
| Water | Placebo comparator | Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract Receives: Dietary Supplement: Water |
| Natural high potency sweetener from leaf extract | Experimental | Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract Receives: Dietary Supplement: Natural high potency sweetener from leaf extract |
| Glucose | Experimental | Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract Receives: Dietary Supplement: Glucose |
| Sucrose | Experimental | Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract Receives: Dietary Supplement: Sucrose |
| Maltodextrin | Experimental | Beverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy intake
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects energy intake (kcal) in healthy lean individuals.
Measured: 1 hour
Appetite ratings
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects appetite ratings (VAS scales) in healthy lean individuals.
Measured: 1 hour
Food-cue responses
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects food-cue responses (reaction times) in healthy lean individuals.
Measured: 1 hour
Blood glucose levels
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects blood glucose levels (mmol/L) in healthy lean individuals.
Measured: 1 hour
Secondary outcomes (1)
Hedonic ratings
Examine how participants rate the hedonic attributes of the test beverages (Sweetness, pleasantness, etc) and the meal
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start26 Apr 2018
- Primary completion15 Oct 2018
- Study completion15 Nov 2018
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 ObesityStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Principal investigator, Nikoleta Stamataki, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711084
- Sponsor's protocol ID
- 2310
- Status last verified
- Feb 2019
- First submitted
- 8 Oct 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stamataki NS, Scott C, Elliott R, McKie S, Bosscher D, McLaughlin JT. Stevia Beverage Consumption prior to Lunch Reduces Appetite and Total Energy Intake without Affecting Glycemia or Attentional Bias to Food Cues: A Double-Blind Randomized Controlled Trial in Healthy Adults. J Nutr. 2020 May 1;150(5):1126-1134. doi: 10.1093/jn/nxaa038.
PubMed 32125421
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Dietary Sweetness on Neurocognitive Responses to Visual Food Cues, Appetite and Physiological Parameters on Normal Weight Adults: a Pilot Study
- ClinicalTrials.gov ID
- NCT03711084
- Acronym / sponsor ID
- 2310
- Conditions
- Obesity
- Keywords
- non-nutritive sweeteners, sucrose, food-cue responses, appetite, blood glucose, energy intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 18 Oct 2018 (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 examine potential differences in neurocognitive responses to food-related cues, physiological and appetite responses as well as subsequent energy intake following the consumption of preloads differing in sweetness and/ or postprandial metabolic effects in healthy normal weight subjects.
Detailed description
Excess consumption of caloric sweeteners, together with the high availability of palatable food cues are some of the factors for the alarming high rates of overweight and obesity. Although non-nutritive sweeteners (NNS) are used to decrease energy content of foods and beverages, there is an on-going debate on the relationship between NNS intake, obesity and cardiometabolic risk. Caloric sugars have a differing effect on physiological responses compared to NNS. However it is almost wholly unknown how NNS consumption affects eating behaviour and cognitive processes.
This study compares the performance on food related neurocognitive tasks following the consumption of the test preloads on 5 visits. In particular, sucrose, glucose, maltodextrin, water or a natural high potency sweetener from leaf extract will be ingested as single test agents in randomized order. Water will be used as a control for gastric distension and non-sweet, whereas maltodextrin will be used as a non-sweet control for carbohydrate content.
Participants will be asked to attend a screening visit at the Neuroscience and Psychiatry Unit of the University of Manchester on a morning after overnight fast. Participants' weight and height, fasting blood glucose and blood pressure will be measured. This will be followed by some questionnaires regarding general health status, weight and dieting history and eating behaviour.
Participants who satisfy the inclusion criteria, will be then invited to take part in the full study. This will require 5 separate visits at the University of Manchester, which will be scheduled between 11.30 and 13.30. Participants will have to attend these visits after having fasted for 3-4 hours and will be asked to have their regular breakfast in the morning before the testing session, and then not eat or drink anything else for 3-4 hours until they come in the lab for the testing session. Water will be allowed up to 1 hour prior to your testing session. Prior to each testing session participants will be asked to have the same breakfast, and they will have to provide a picture of the breakfast each time to ensure compliance.
The 5 visits correspond to 5 test beverages, both the participants and the investigators are blinded to the study treatments. Blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will also be asked to rate their feeling of hunger, fullness etc using visual analogue scales (VAS) at the same time points 0, 15, 30 and 60 min.
Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks. They are designed to capture behaviour in response to food cue presentation. This will last approximately 15 min.
Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. Each session is anticipated to last for approximately 1 hour.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Water | Placebo comparator | Dietary Supplement: WaterBeverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract |
| Natural high potency sweetener from leaf extract | Experimental | Dietary Supplement: Natural high potency sweetener from leaf extractBeverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract |
| Glucose | Experimental | Dietary Supplement: GlucoseBeverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract |
| Sucrose | Experimental | Dietary Supplement: SucroseBeverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract |
| Maltodextrin | Experimental | Dietary Supplement: MaltodextrinBeverage containing either water, glucose, sucrose, maltodextrin or a natural high potency sweetener from leaf extract |
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 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)
Key exclusion criteria (18 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, Vegetarian Diet, Raw Food Diet etc.
- Subjects having breakfast fewer than 5 times per week.
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 |
|---|---|---|
| Natural high potency sweetener from leaf extractUpon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. | Dietary supplement | Natural high potency sweetener from leaf extract |
| GlucoseUpon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. | Dietary supplement | Glucose |
| SucroseUpon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. | Dietary supplement | Sucrose |
| MaltodextrinUpon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. | Dietary supplement | Maltodextrin |
| WaterUpon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min. Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full. | Dietary supplement | Water |
Primary outcome
Energy intake
Time frame: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects energy intake (kcal) in healthy lean individuals.
Appetite ratings
Time frame: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects appetite ratings (VAS scales) in healthy lean individuals.
Food-cue responses
Time frame: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects food-cue responses (reaction times) in healthy lean individuals.
Blood glucose levels
Time frame: 1 hour
Examine how the consumption of sweet vs. non- sweet and energy-containing vs. non-energy containing preloads affects blood glucose levels (mmol/L) in healthy lean individuals.
1 secondary outcome
Hedonic ratings
Time frame: 1 hour
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 15 Feb 2019.
- Derived from this study: PubMed 32125421Stamataki NS, Scott C, Elliott R, McKie S, Bosscher D, McLaughlin JT. Stevia Beverage Consumption prior to Lunch Reduces Appetite and Total Energy Intake without Affecting Glycemia or Attentional Bias to Food Cues: A Double-Blind Randomized Controlled Trial in Healthy Adults. J Nutr. 2020 May 1;150(5):1126-1134. doi: 10.1093/jn/nxaa038.
- 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 Natural high potency sweetener from leaf extract, Glucose and Sucrose in people with 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 18 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 15 Feb 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. 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: 1 hour). The study lists 4 primary outcomes in all. 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 NCT03711084, 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 15 Feb 2019.