The Validation of Various Dietary Assessment Methodologies

Diet Habit Clinical Trial

Official title:

The Validation of Various Dietary Assessment Methodologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03364452
• Other study ID #: Diet Assessment Methods
• Status: Completed
• Phase: N/A
• First received: November 30, 2017
• Last updated: December 5, 2017
• Start date: April 8, 2016
• Est. completion date: December 23, 2016

Study information

• Verified date: December 2017
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 artificial sweetener consumption. Additionally, the investigators are examining the ability of a rapid beverage intake questionnaire (BEVQ-15) to determine Healthy Beverage Index scores.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 23, 2016
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Diet Habit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Primary	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.	2 weeks
Secondary	Metabolic syndrome and non-nutritive sweetener intake	Association between metabolic syndrome incidence and non-nutritive sweetener intake	2 weeks