ObesityWeightNCT04723082
Impacts of Sugar-Sweetened Beverage on Body Weight
An observational study of Obesity, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The obesity epidemic is a major public health problem. Weight gain is strongly associated with an increase in the incidence of complex health conditions such as type 2 diabetes (T2D), cardiovascular disease, stroke, and cancers. Behaviours linked to food and beverage consumption can greatly affect body weight. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2021to 22 Jul 2022
- Phase
- Observational
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: About 128 healthy adult volunteers are required to participate in the study. They need to be living in Aberdeen City or Aberdeenshire. Participants will be requited by flyers distributing from the public who live in Aberdeen city and Aberdeenshire. Also, from the Energetics research group account on twitter. Participants will volunteer to take part independently.
Who may be able to join
- Healthy men and women (with no known significant health problems)
- 18 years and older (The form required me to put the maximum age, which is not stated in the protocol, so I put 100)
Who cannot join
- Less than 18 years
- Diabetic individuals
- Not living in Aberdeen city or shire
- Pregnant women
- Non-English speaker and non-able to read and understand study information sheet.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Rowett Institute, University of Aberdeen
Aberdeen, AB25 2ZD
About this study
Official title: Impacts of Sugar-Sweetened Beverage Consumption on Body Weight Regulation
The obesity epidemic is a major public health problem. Weight gain is strongly associated with an increase in the incidence of complex health conditions such as type 2 diabetes (T2D), cardiovascular disease, stroke, and cancers. Behaviours linked to food and beverage consumption can greatly affect body weight. Frequent consumption of sugar-sweetened beverages such as carbonated soft-drinks, energy and sport drinks, fruit juices from concentrate, soda and flavoured milk and water is considered to be an unhealthy dietary behaviour.
This project will investigate how variations in an individual's genes may impact their consumption of SSBs and thus body fatness. Specifically, the project will aim to investigate whether genetic variation in the taste receptors TAS1R2 and TAS1R3 can influence an individuals' perception and liking of a sweet palate and their intake of SSBs in UK. This study will be an experimental study that evaluates human body composition by different measurements. Additionally, two different biomarkers will be used for the study, such as blood and urine samples. Blood samples are the preferred source for DNA testing, rather than saliva. Urine samples will be used to look at the sugar level in the human body as a measure of body composition using deuterium dilution techniques. Around 128 adult volunteers will be recruited from Aberdeen, UK to participate in the study, which will take approximately one week to complete for each individual.
Read the detailed description
To achieve this study, recruited volunteers (n=128), aged 18 years and older will visit the Rowett Institute at the University of Aberdeen on one occasion, their body composition will be measured by 3 methods: BOD POD, Tanita scales, and deuterium dilution and their consumption of SSBs will be assessed using 24h dietary recall (once in the lab and once at home over the phone). In addition, a urine sample will be collected and assessed for potential markers of sugar. Individuals will have a blood sample (up to 5 ml) taken to determine genetic variation in their taste receptors and they will also undergo a taste test using randomised tasting of a panel of 9 different sugar solutions measured in triplicate (in total they will taste 27 little cups).
The researcher will advise all the study subjects to come to a designated room in the Rowett Research Institute to complete the measurement regime at a pre-determined time between 6:30 am - 3:00 pm on their appointment day with about 2 participants per day. Each subjects measurments will take 4 hours to complete. Volunteers will complete informed consent before starting participate in the study:
Pre visit:
- Volunteers will be asked not to consume any food or drink other than water for 10 hours before their site visit, and avoid heavy exercise for 12 hours before to improve the accuracy of the body composition measurements.
Phase I:
- Volunteers will be asked to collect (fasted) urine sample to determine normal markers for sugar in their body. This will also be used to determine background isotope levels for the deuterium dilution protocol (5 minutes for collecting urine sample)
- Measurement of weight and height (BMI) (5 minutes)
- Deuterium dilution (consumption of deuterium dose; volume determined by the subjects body weight) (10 minutes).
- Demographic questionnaire (10 minutes).
- 24-h recall of SSB intake (face to face) (10 minutes). Rest Period
Phase II:
- Tanita scale (5 minutes).
- BOD POD (10 minutes). Rest Period
Phase III:
- Blood sample (15 minutes).
- Taste test (sugar solution) (50 minutes).
- Final urine sample (5 minutes).
Follow Up:
- 24-h recall SSB intake after 1 week (10 minutes).
The compulsory tests are: urine sample, measuring body composition by (deuterium, Tanita and Bod Pod), and demographic questionnaire, 24-h recall of SSB intake (face to face and phone interview), measuring weight and height (BMI) and Blood sample for genetics and the taste test.
- Conditions
- Obesity
- Keywords
- Body fatness, Sweet taste receptors, Sugar-sweetened beverage
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the correlation between consumption of SSBs and body fatness.
Consumption of SSBs and other factors such as dietary behaviour and sociodemographic were examined previously among children and adults. Excessive consumption of SSBs in children, adolescents and adults strongly contribute to an increased risk of developing several health conditions. Statistical data that has been collected over time show the association between the consumption of SSBs and increased body weight.
Measured: 6 months
Secondary outcomes (1)
This research will reveal the relationship between genetic variation of taste receptors in UK adults linked with their sweet taste preferences and consumption of SSBs.
Genetic variation of an individual's taste receptors also plays a significant role in their preferences, and thus consumption of sugar and thus SSBs.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start10 Sep 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Hambly, PhD, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723082
- Sponsor's protocol ID
- 2-078-20
- Acronym
- Weight
- Status last verified
- Dec 2023
- First submitted
- 20 Jan 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Archiving of study documents will be authorized by the sponsor at the end of the study. Essential documents will be archived for a minimum of 10 years after the completion. Documents which are not archived will be destroyed (with authorization from the sponsor). All the archived data will be stored in the HSB archive within the UoA site. Prior to archiving, during the study, material will be stored in locked filing cabinets located in the archive room in the HNU at the Rowett Institute
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Sugar-Sweetened Beverage Consumption on Body Weight Regulation
- ClinicalTrials.gov ID
- NCT04723082
- Acronym / sponsor ID
- Weight / 2-078-20
- Conditions
- Obesity
- Keywords
- Body fatness, Sweet taste receptors, Sugar-sweetened beverage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 25 Jan 2021 (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 obesity epidemic is a major public health problem. Weight gain is strongly associated with an increase in the incidence of complex health conditions such as type 2 diabetes (T2D), cardiovascular disease, stroke, and cancers. Behaviours linked to food and beverage consumption can greatly affect body weight. Frequent consumption of sugar-sweetened beverages such as carbonated soft-drinks, energy and sport drinks, fruit juices from concentrate, soda and flavoured milk and water is considered to be an unhealthy dietary behaviour.
This project will investigate how variations in an individual's genes may impact their consumption of SSBs and thus body fatness. Specifically, the project will aim to investigate whether genetic variation in the taste receptors TAS1R2 and TAS1R3 can influence an individuals' perception and liking of a sweet palate and their intake of SSBs in UK. This study will be an experimental study that evaluates human body composition by different measurements. Additionally, two different biomarkers will be used for the study, such as blood and urine samples. Blood samples are the preferred source for DNA testing, rather than saliva. Urine samples will be used to look at the sugar level in the human body as a measure of body composition using deuterium dilution techniques. Around 128 adult volunteers will be recruited from Aberdeen, UK to participate in the study, which will take approximately one week to complete for each individual.
Detailed description
To achieve this study, recruited volunteers (n=128), aged 18 years and older will visit the Rowett Institute at the University of Aberdeen on one occasion, their body composition will be measured by 3 methods: BOD POD, Tanita scales, and deuterium dilution and their consumption of SSBs will be assessed using 24h dietary recall (once in the lab and once at home over the phone). In addition, a urine sample will be collected and assessed for potential markers of sugar. Individuals will have a blood sample (up to 5 ml) taken to determine genetic variation in their taste receptors and they will also undergo a taste test using randomised tasting of a panel of 9 different sugar solutions measured in triplicate (in total they will taste 27 little cups).
The researcher will advise all the study subjects to come to a designated room in the Rowett Research Institute to complete the measurement regime at a pre-determined time between 6:30 am - 3:00 pm on their appointment day with about 2 participants per day. Each subjects measurments will take 4 hours to complete. Volunteers will complete informed consent before starting participate in the study:
Pre visit:
- Volunteers will be asked not to consume any food or drink other than water for 10 hours before their site visit, and avoid heavy exercise for 12 hours before to improve the accuracy of the body composition measurements.
Phase I:
- Volunteers will be asked to collect (fasted) urine sample to determine normal markers for sugar in their body. This will also be used to determine background isotope levels for the deuterium dilution protocol (5 minutes for collecting urine sample)
- Measurement of weight and height (BMI) (5 minutes)
- Deuterium dilution (consumption of deuterium dose; volume determined by the subjects body weight) (10 minutes).
- Demographic questionnaire (10 minutes).
- 24-h recall of SSB intake (face to face) (10 minutes). Rest Period
Phase II:
- Tanita scale (5 minutes).
- BOD POD (10 minutes). Rest Period
Phase III:
- Blood sample (15 minutes).
- Taste test (sugar solution) (50 minutes).
- Final urine sample (5 minutes).
Follow Up:
- 24-h recall SSB intake after 1 week (10 minutes).
The compulsory tests are: urine sample, measuring body composition by (deuterium, Tanita and Bod Pod), and demographic questionnaire, 24-h recall of SSB intake (face to face and phone interview), measuring weight and height (BMI) and Blood sample for genetics and the taste test.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- About 128 healthy adult volunteers are required to participate in the study. They need to be living in Aberdeen City or Aberdeenshire. Participants will be requited by flyers distributing from the public who live in Aberdeen city and Aberdeenshire. Also, from the Energetics research group account on twitter. Participants will volunteer to take part independently.
Key inclusion criteria (2 listed)
- Healthy men and women (with no known significant health problems)
- 18 years and older (The form required me to put the maximum age, which is not stated in the protocol, so I put 100)
Key exclusion criteria (5 listed)
- Less than 18 years
- Diabetic individuals
- Not living in Aberdeen city or shire
- Pregnant women
- Non-English speaker and non-able to read and understand study information sheet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To establish the correlation between consumption of SSBs and body fatness.
Time frame: 6 months
Consumption of SSBs and other factors such as dietary behaviour and sociodemographic were examined previously among children and adults. Excessive consumption of SSBs in children, adolescents and adults strongly contribute to an increased risk of developing several health conditions. Statistical data that has been collected over time show the association between the consumption of SSBs and increased body weight.
1 secondary outcome
This research will reveal the relationship between genetic variation of taste receptors in UK adults linked with their sweet taste preferences and consumption of SSBs.
Time frame: 6 months
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 2023.
- Genetic variation in TAS1R2Link provided by the sponsor.
- Human sweet taste, the perception and intake of sweetLink provided by the sponsor.
- Variation in the human TAS1RLink provided by the sponsor.
- sweetened beverage consumptionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Archiving of study documents will be authorized by the sponsor at the end of the study. Essential documents will be archived for a minimum of 10 years after the completion. Documents which are not archived will be destroyed (with authorization from the sponsor). All the archived data will be stored in the HSB archive within the UoA site. Prior to archiving, during the study, material will be stored in locked filing cabinets located in the archive room in the HNU at the Rowett Institute
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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.
Catherine Hambly, PhD principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Aberdeen 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 2 inclusion and 5 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 2023. 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?
To establish the correlation between consumption of SSBs and body fatness. (time frame: 6 months). 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 2023.