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CompletedNCT03364452Updated Dec 7, 2017

The Validation of Various Dietary Assessment Methodologies

An observational study in Diet Habit, sponsored by Virginia Polytechnic Institute and State University. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Virginia Polytechnic Institute and State University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
125
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Diet Habit

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Keywords

  • Dietary Assessment Methodology
  • beverages
  • non-nutritive sweeteners
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In context

Feeding Behavior

985 studies on the registry are indexed under Feeding Behavior; 178 are open to participants now.

This study's enrollment of 125 is below the median of 183 across 270 observational studies indexed under Feeding Behavior.

Browse Feeding Behavior studies →

Lead sponsor

Virginia Polytechnic Institute and State University is the lead sponsor of 127 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • N/A
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
125 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. non-nutritive sweetener intake

    agreement between non-nutritive sweetener intake from the food frequency questionnaire and dietary recalls and between the urinary biomarker and dietary recalls

    Time frame: 2 weeks

  2. Healthy Beverage Index Scores

    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.

    Time frame: 2 weeks

Secondary outcomes

  1. Metabolic syndrome and non-nutritive sweetener intake

    Association between metabolic syndrome incidence and non-nutritive sweetener intake

    Time frame: 2 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Hess EL, Myers EA, Swithers SE, Hedrick VE. Associations Between Nonnutritive Sweetener Intake and Metabolic Syndrome in Adults. J Am Coll Nutr. 2018 Aug;37(6):487-493. doi: 10.1080/07315724.2018.1440658. Epub 2018 Mar 30. PubMed 29601264 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03364452
Responsible party
Valisa Hedrick (Assistant Professor, Virginia Polytechnic Institute and State University) — Principal investigator
First posted
Dec 6, 2017
Start date
Apr 8, 2016
Primary completion
Dec 23, 2016
Completion
Dec 23, 2016
Last update
Dec 7, 2017

Study contacts

Valisa E Hedrick, PhD, RDN
principal investigator · Virginia Polytechnic Institute and State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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