NCT04723082

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

January 20, 2021

Last Update Submit

December 6, 2023

Conditions

Keywords

Body fatnessSweet taste receptorsSugar-sweetened beverage

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    6 months

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Healthy men and women (with no known significant health problems)
  • years and older (The form required me to put the maximum age, which is not stated in the protocol, so I put 100)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Rowett Institute, University of Aberdeen

Aberdeen, AB25 2ZD, United Kingdom

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

We collected blood and urine samples. The researcher acknowledges the risks and ethical issues of taking biological samples, wearing correct PPE, and following the procedures for collection and handling samples. Participants will be fully aware of the study process via the PIS.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine Hambly, PhD

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 25, 2021

Study Start

September 10, 2021

Primary Completion

July 22, 2022

Study Completion

July 22, 2022

Last Updated

December 13, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
In line with MRC regulations all data will be stored for 10 years.
Access Criteria
Individual participant data (after de-identification) that underlie the results of this study will be available upon reasonable requests to investigators whose proposed used of data has been approved by an independent review committee identified for this purpose.
More information

Locations