Diet HabitNCT03364452
The Validation of Various Dietary Assessment Methodologies
An observational study of Diet Habit, run by Virginia Polytechnic Institute and State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habit
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2016to 23 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- The subject pool for this study includes adults. Participants must be 18 years of age or older and must speak English.
Who cannot join
- N/A
About this study
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.
- Conditions
- Diet Habit
- Keywords
- Dietary Assessment Methodology, beverages, non-nutritive sweeteners
- Medical subject headings
- Feeding Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
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.
Measured: 2 weeks
Secondary outcomes (1)
Metabolic syndrome and non-nutritive sweetener intake
Association between metabolic syndrome incidence and non-nutritive sweetener intake
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start8 Apr 2016
- Primary completion23 Dec 2016
- Study completion23 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valisa Hedrick, Virginia Polytechnic Institute and State University
- Investigators
- Valisa E Hedrick, PhD, RDN, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364452
- Sponsor's protocol ID
- Diet Assessment Methods
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Validation of Various Dietary Assessment Methodologies
- ClinicalTrials.gov ID
- NCT03364452
- Acronym / sponsor ID
- Diet Assessment Methods
- Conditions
- Diet Habit
- Keywords
- Dietary Assessment Methodology, beverages, non-nutritive sweeteners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- The subject pool for this study includes adults. Participants must be 18 years of age or older and must speak English.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
Metabolic syndrome and non-nutritive sweetener intake
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Derived from this study: PubMed 29601264Hess 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valisa E Hedrick, PhD, RDN principal investigator
Virginia Polytechnic Institute and State University
Questions about this trial
What is this clinical trial studying?
An observational study of Diet Habit, run by Virginia Polytechnic Institute and State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-nutritive sweetener intake (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.