Monell USDA Taste Test Study

NCT04079855 | Active Not Recruiting DMC

• 2 other identifiers: HS65 - MUTT Study5U01DC013529
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Diet

Outcome Measures

Primary Outcomes (10)

• Taste intensity of food

  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.

  Month 1

• Taste intensity of food

  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.

  Month 2

• Taste intensity of food

  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.

  Month 3

• Taste intensity of food

  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.

  Month 4

• Taste intensity of food

  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.

  Month 6

• Taste preference

  Most liked concentration. Foods will be scaled as g flavor/100 g food.

  Month 1

• Taste preference

  Most liked concentration. Foods will be scaled as g flavor/100 g food.

  Month 2

• Taste preference

  Most liked concentration. Foods will be scaled as g flavor/100 g food.

  Month 3

• Taste preference

  Most liked concentration. Foods will be scaled as g flavor/100 g food.

  Month 4

• Taste preference

  Most liked concentration. Foods will be scaled as g flavor/100 g food.

  Month 6

Secondary Outcomes (2)

• Diet-related adverse events

  Daily during the Baseline (Month 1), Months 2-6

• Diet-related early discontinuation from intervention

  Daily during the Baseline (Month 1), Months 2-6

Other Outcomes (19)

• Glucose

  Baseline (Month 1) week 3 or 4, Months 2-4, Month 6

• Insulin

  Baseline (Month 1) week 3 or 4, Months 2-4, Month 6

• c-peptide

  Baseline (Month 1) week 3 or 4, Months 2-4, Month 6

Study Arms (3)

Diet composition 1

EXPERIMENTAL

A diet with a specified macronutrient composition different from arms 2 and 3.

Other: Diet composition 1

Diet composition 2

EXPERIMENTAL

A diet with a specified macronutrient composition different from arms 1 and 3.

Other: Diet composition 2

Diet composition 3

EXPERIMENTAL

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

Other: Diet composition 3

Interventions

Diet composition 1 OTHER

A diet with a specified macronutrient composition different from arms 2 and 3.

Diet composition 1

Diet composition 2 OTHER

A diet with a specified macronutrient composition different from arms 1 and 3.

Diet composition 2

Diet composition 3 OTHER

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

Diet composition 3

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Have body weight less than 110 lbs.
• Known (self-reported) allergy or adverse reaction to study foods or ingredients
• Added sugars intake at baseline \< 10% of total energy.
• A dietary pattern inconsistent with the dietary intervention (i.e., vegan, vegetarian, extremes of protein, fat, carbohydrate intake).
• Body mass index less than 18 or greater than 40 kg/m2
• Women who have given birth during the previous 12 months, are pregnant, are lactating, or plan to become pregnant during the study.
• Use of appetite suppressants or other anti-obesity medication during the past 6 months.
• History of bariatric or certain other surgeries related to weight control.
• History or presence of diabetes, kidney disease, liver disease, certain cancers, gout, hyperthyroidism, untreated or unstable hypothyroidism, gastrointestinal disease, pancreatic disease, other metabolic diseases, malabsorption syndromes, phenylketonuria, or endocrine disorders that may interfere with the study outcomes.
• Individuals with any gastrointestinal issues, including bariatric surgery, inflammatory bowel disease, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, nutrient malabsorption disease, or Crohn's Disease Smokers or other tobacco/marijuana users (within 6 months prior to the study).
• History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians).
• Known taste or smell disorders, including weak or absent sense of taste or smell (screening procedures include a basic taste and smell sensitivity tests), abnormal taste in the mouth (e.g., bitter or metallic "phantom" tastes), or other taste abnormality.
• Use of medications within one month prior to the study that moderately to severely affect taste.
• Tested positive for COVID-19 in the past 4 weeks.
• Volunteers who have lost or gained \>10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 12 months.

Sponsors & Collaborators

• David Baer: lead
• Monell Chemical Senses Center: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Officials

• Paul Wise, PhD

  Monell Chemical Senses Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention is of foods which will look identical. Volunteers will know the color of their treatment assignment but not the actual identity of their treatment. The investigators will use a double masking protocol in which investigators and outcome assessors (study staff who collect primary and secondary measures and data analysts) will not know the treatment assignments or treatment coding (color coded) scheme.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Supervisory Reserach Physiologist

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: June 15, 2023
• Primary Completion: August 9, 2024
• Study Completion: August 8, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

US (1)