Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04723082 |
| Other study ID # |
2-078-20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2021 |
| Est. completion date |
July 22, 2022 |
Study information
| Verified date |
December 2023 |
| Source |
University of Aberdeen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
