Impacts of Sugar-Sweetened Beverage on Body Weight (Weight)

December 6, 2023 updated by: University of Aberdeen

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aberdeen, United Kingdom, AB25 2ZD
        • The Rowett Institute, University of Aberdeen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Genetic variation of an individual's taste receptors also plays a significant role in their preferences, and thus consumption of sugar and thus SSBs.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Catherine Hambly, PhD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2021

Primary Completion (Actual)

July 22, 2022

Study Completion (Actual)

July 22, 2022

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-078-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

In line with MRC regulations all data will be stored for 10 years.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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