Monell USDA Taste Test Study

Not Applicable

Active, not recruiting

• Conditions: Healthy Diet
• Interventions: Other: Diet composition 1; Other: Diet composition 2; Other: Diet composition 3

• Registration Number: NCT04079855
• Lead Sponsor: David Baer

Brief Summary

Overconsumption of carbohydrates has been implicated as a cause of significant public health problems including obesity and diabetes. The most effective approach to alter dietary pattern and improve public health is unknown. Gradual and abrupt changes in dietary pattern have been tried in small, uncontrolled trials, but it is not clear which approach is most effective. The primary objective of this study is to evaluate different approaches to changing dietary pattern for altering flavor perception in foods and beverages and for altering preference for flavor.

Detailed Description

This comprehensive, well-controlled diet study aims to evaluate and compare different approaches to alter dietary pattern, especially macronutrient profile. The investigators propose a prospective, randomized trial that is designed to overcome the above limitations to test the hypothesis that changing dietary macronutrient profile can change taste perception and food preference. Data from this study will provide information that policy makers, regulators, and the food industry can use to develop successful approaches (gradual or otherwise) for providing healthy diets in the marketplace.

Study Timeline

• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2023-06-15
• Primary Completion: 2024-08-09
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Last Update Posted: 2025-01-14
• Study Completion: 2025-08-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet composition 1	Diet composition 1	A diet with a specified macronutrient composition different from arms 2 and 3.
Diet composition 2	Diet composition 2	A diet with a specified macronutrient composition different from arms 1 and 3.
Diet composition 3	Diet composition 3	A diet with a specified macronutrient composition different from arms 1 and 2, based on the current information about the US macronutrient composition.

Primary Outcome Measures

Name	Time	Method
Taste intensity of food	Month 6	Rating taste intensity from barely detectable to strong using a general labeled magnitude scale. The name of the scale is the general labeled magnitude scale. The value of the response is recorded on the scale as "barely detectable", "weak", "moderate, strong", "very strong", and "strongest imaginable sensation of any kind." None of these responses is considered better or worse than any other.
Taste preference	Month 6	Most liked concentration. Foods will be scaled as g flavor/100 g food.

Secondary Outcome Measures

Name	Time	Method
Diet-related adverse events	Daily during the Baseline (Month 1), Months 2-6	Adverse events related to the diet tabulated by study-arm and severity.
Diet-related early discontinuation from intervention	Daily during the Baseline (Month 1), Months 2-6	Subject withdraws citing issues with the study diet, or investigators withdraw the subject from the study due to concerns over how the subject reacts to the study diet.

Trial Locations

Locations (1)

USDA-ARS, Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States