The Validation of Various Dietary Assessment Methodologies

December 5, 2017 updated by: Valisa Hedrick, Virginia Polytechnic Institute and State University
The purpose of the study is see how well two dietary intake questionnaires, blood values, and urine samples can estimate what participants are eating and drinking. Specifically, the investigators are looking at the validity of a new artificial sweetener food frequency questionnaire and a urinary biomarker for artificial sweetener consumption. Additionally, the investigators are examining the ability of a rapid beverage intake questionnaire (BEVQ-15) to determine Healthy Beverage Index scores.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The role of beverages in overall dietary patterns and health is controversial but remains an important key target for clinical interventions and public policy. Additionally, non-nutritive sweetener intake is controversial. It is difficult to measure intake; therefore, it is difficult to determine associations to health outcomes. For this study, the investigators plan to study 125 adult participants during 3 visits over 2 weeks. The purpose of this study is two-fold: 1) to assess the utility of two food frequency questionnaires (the Healthy Beverage Index and the Non-Nutritive Sweetener questionnaire) and 2) to assess the capabilities of a non-nutritive sweetener biomarker.

The first goal of this study is to assess the validity of the Healthy Beverage Index (HBI) via the BEVQ-15 questionnaire compared to the HBI via dietary recalls. Additionally, the correlations of HBI scores to dietary intake biomarkers will be assessed (urinary specific gravity) and associations between HBI scores with weight status and related cardio-metabolic health variables will be determined (weight, blood pressure, waist circumference, blood lipids, and glucose). The investigators will assess potential confounds to the HBI (health literacy, socio-economic status, demographics). The second goal is to assess the correlations between the non-nutritive sweetener food frequency questionnaire and the 24-hour dietary recalls.

The investigators predict that 1) HBI scores will not vary significantly between BEVQ-15 and dietary recall assessment methods, 2) HBI scores will be significantly correlated to the dietary biomarker (negative association between urinary specific gravity and total fluid intake), 3) there will be statistically significant relationships between HBI scores and health indicators, and 4) non-nutritive sweetener consumption reported in the non-nutritive sweetener questionnaire and the 24-hour dietary recalls will be significantly correlated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The aim of this project is to study dietary consumption patterns and identify a method to assess habitual non-nutritive sweetener consumption in the adult population (food frequency questionnaire and biomarker). Thus, our study aims to recruit a sample of participants that represents the general population.

Description

Inclusion Criteria:

  • The subject pool for this study includes adults. Participants must be 18 years of age or older and must speak English.

Exclusion Criteria:

  • N/A

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
non-nutritive sweetener intake
Time Frame: 2 weeks
agreement between non-nutritive sweetener intake from the food frequency questionnaire and dietary recalls and between the urinary biomarker and dietary recalls
2 weeks
Healthy Beverage Index Scores
Time Frame: 2 weeks
Healthy Beverage Index scores are similar to Healthy Eating Scores and range from 0-100, with higher scores indicating greater agreement with beverage recommendations and guidelines. Agreement between total Healthy Beverage Index Scores from the BEVQ-15 (a beverage frequency questionnaire) and Healthy Beverage Index Scores from dietary recalls will be compared.
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic syndrome and non-nutritive sweetener intake
Time Frame: 2 weeks
Association between metabolic syndrome incidence and non-nutritive sweetener intake
2 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valisa E Hedrick, PhD, RDN, Virginia Polytechnic Institute and State University

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Diet Assessment Methods

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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