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Monell USDA Taste Test Study (MUTT)

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ClinicalTrials.gov Identifier: NCT04079855
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborators:
Monell Chemical Senses Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
David Baer, USDA Beltsville Human Nutrition Research Center

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.

Condition or disease Intervention/treatment Phase
Healthy Diet Other: Diet composition 1 Other: Diet composition 2 Other: Diet composition 3 Other: Diet composition 4 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: Diet-induced Modification of Sweet Taste Perception and Preference
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : August 8, 2023
Estimated Study Completion Date : August 8, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diet composition 1
A diet with a specified macronutrient composition different from arms 2, 3, and 4.
Other: Diet composition 1
A diet with a specified macronutrient composition different from arms 2, 3, and 4.

Experimental: Diet composition 2
A diet with a specified macronutrient composition different from arms 1, 3, and 4.
Other: Diet composition 2
A diet with a specified macronutrient composition different from arms 1, 3, and 4.

Experimental: Diet composition 3
A diet with a specified macronutrient composition different from arms 1, 2, and 4.
Other: Diet composition 3
A diet with a specified macronutrient composition different from arms 1, 2, and 4.

Experimental: Diet composition 4
A diet with a specified macronutrient composition different from arms 1, 2, and 3 based on the current information about the US macronutrient composition.
Other: Diet composition 4
A diet with a specified macronutrient composition different from arms 1, 2, and 3 based on the current information about the US macronutrient composition.




Primary Outcome Measures :
  1. Taste intensity of food [ Time Frame: Month 1 ]
    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.

  2. Taste intensity of food [ Time Frame: Month 2 ]
    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.

  3. Taste intensity of food [ Time Frame: Month 3 ]
    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.

  4. Taste intensity of food [ Time Frame: Month 4 ]
    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.

  5. Taste intensity of food [ Time Frame: 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.

  6. Taste preference [ Time Frame: Month 1 ]
    Paired comparison food preference. Foods will be scaled as g flavor/100 g of food.

  7. Taste preference [ Time Frame: Month 2 ]
    Paired comparison food preference. Foods will be scaled as g flavor/100 g of food.

  8. Taste preference [ Time Frame: Month 3 ]
    Paired comparison food preference. Foods will be scaled as g flavor/100 g of food.

  9. Taste preference [ Time Frame: Month 4 ]
    Paired comparison food preference. Foods will be scaled as g flavor/100 g of food.

  10. Taste preference [ Time Frame: Month 6 ]
    Paired comparison food preference. Foods will be scaled as g flavor/100 g of food.


Secondary Outcome Measures :
  1. Diet-related adverse events [ Time Frame: Daily during the Baseline (Month 1), Months 2-6 ]
    Adverse events related to the diet tabulated by study-arm and severity.

  2. Diet-related early discontinuation from intervention [ Time Frame: 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.


Other Outcome Measures:
  1. Glucose [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    Glucose is a sugar that circulates in the blood and is used as an energy source for many cells. Glucose will be measured to determine how the treatment is affecting blood glucose regulation. Glucose is measured in units of mg/dL.

  2. Insulin [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    Insulin is a hormone that helps control blood glucose concentration. Insulin will be measured to determine how the treatment is affecting blood glucose regulation. Insulin is measured in units of microIU/mL.

  3. c-peptide [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    c-peptide is a peptide that is formed during the production of insulin. C-peptide will be measured to determine how the treatment is affecting insulin response and blood glucose regulation. c-peptide is measured in units of ng/mL.

  4. Glucagon [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    Glucagon is a hormone that helps control blood glucose concentration. Glucagon will be measured to determine how the treatment is affecting blood glucose regulation. Glucagon is measured in units of pg/mL.

  5. Glucagon-like peptide-1 (GLP-1) [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    GLP-1 is a hormone that helps control blood glucose concentration. GLP-1 will be measured to determine how the treatment is affecting blood glucose regulation. GLP-1 is measured in units of pg/mL.

  6. Anandamide [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    Anandamide is the precursor of a class of physiologically active substances which are involved in brain chemistry. Anandamide will be measured to determine how the treatment is affecting blood compounds that are associated with reward. Anandamide is measured in units of ng/mL.

  7. 2-arachidonyl glycerol (2-AG) [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    2-AG is the precursor of a class of physiologically active substances which are involved in brain chemistry. 2-AG will be measured to determine how the treatment is affecting blood compounds that are associated with reward. 2-AG is measured in units of ng/mL.

  8. Sweet taste receptors genotype [ Time Frame: Baseline month (once) ]
    Genotyping describes the genetic make-up. The known variants of sweet receptor subunit TAS1R3 will be genotyped. Genotype will be measured as a specific sequence of the nucleobases cytosine, guanine, adenine and thymine.

  9. Fecal microbiota will be analyzed for microbial DNA. [ Time Frame: Baseline (Month 1) week 3 or 4, Months 2-4, Month 6 ]
    Fecal microbial communities will be determined using DNA extracted from fecal samples. Fecal microbial communities will be used to determine how the treatment is affecting fecal microbial populations. Fecal microbiota are measured in measured in operational taxonomic units (OTUs).

  10. Body weight [ Time Frame: Baseline, Months 2-4 M-F, Month 6 at end of study ]
    Body weight is the mass of a person. Body weight is measured wearing street clothes without shoes or other heavy items in the pockets. Body weight is used to adjust energy intake to maintain weight maintenance. Body weight is measured in kg.

  11. Waist circumference [ Time Frame: Screening and Month 6 at end of study ]
    Waist circumference is the distance around an individual at a specific location. Waist circumference is measured in cm.

  12. Blood pressure [ Time Frame: Screening and Month 6 at end of study ]
    Blood pressure is a measure of the pressure produced by the heart on the walls of the blood vessels at different times during the heartbeat. Blood pressure is measured in mm Hg (mercury).

  13. Power of Food Scale [ Time Frame: Baseline and Month 6 end of study ]
    A questionnaire that measures factors related to food preference and eating behavior. There are 15 items on the questionnaire. Each item is recorded as a 5-point Likert scale with a value of 1, 2, 3, 4, or 5 corresponding to "I don't agree", "I agree a little", "I agree somewhat", "I agree quite a bit, and "I strongly agree". A total score is determined as the sum of the responses. None of these responses is considered better or worse than any other.

  14. Emotional Eating Scale [ Time Frame: Baseline and Month 6 end of study ]
    A questionnaire that measures factors related to food preference and eating behavior. There are 25 items on the questionnaire. Each item is recorded as a 5-point Likert scale with a value of 1, 2, 3, 4, or 5 corresponding to "no desire to eat", "a small desire to eat", "a moderate desire to eat", "a strong urge to eat", or "an overwhelming urge to eat." A total score is determined as the sum of the responses. None of these responses is considered better or worse than any other.

  15. Three Factor Eating Questionnaire [ Time Frame: Baseline and Month 6 end of study ]
    A questionnaire that measures factors related to food preference and eating behavior.

  16. Dutch Eating Behaviour Questionnaire [ Time Frame: Baseline and Month 6 end of study ]
    A questionnaire that measures factors related to food preference and eating behavior.

  17. Yale Food Addiction Scale [ Time Frame: Baseline and Month 6 end of study ]
    A questionnaire that measures factors related to food preference and eating behavior. There are 16 items on the questionnaire that are scored as a 5-point Likert scale with a value of 0, 1, 2, 3, or 4, corresponding to "never", "once a month", "2-4 times a month", "2-3 times a week", or "4 or more times or daily." There is 1 item on the questionnaire that is scored as a 5-point Likert scale with a value of 0, 1, 2, 3, or 4, corresponding to "1 or fewer times", "2 times", "3 times", "4 times", or "5 or more times." There are 8 items scored as "no" (0) or "yes" (1). A total score is determined as the sum of the responses. None of these responses is considered better or worse than any other.

  18. Barrat Impulsiveness Scale [ Time Frame: Baseline and Month 6 end of study ]
    A questionnaire that measures factors related to food preference and eating behavior. There are 11 items on the questionnaire that are scored as a 4-point Likert scale with a value of 1, 2, 3, or 4 corresponding to "rarely/never", "occasionally", "often", or "almost always/always." A total score is determined as the sum of the responses. None of these responses is considered better or worse than any other.

  19. Dietary Satisfaction Questionnaire [ Time Frame: Baseline, weekly during Months 3-5, and Month 6 end of intervention ]
    A questionnaire that measures factors related to food preference and eating behavior.

  20. Food Craving Inventory [ Time Frame: Baseline, weekly during Months 3-5, and Month 6 end of intervention ]
    A questionnaire that measures factors related to food preference and eating behavior.

  21. Free-choice food intake [ Time Frame: Baseline, end of Month 4,and Month 6 end of study ]
    Free-choice food intake is a measure of the energy consumed from preferred foods. Free-choice food intake will be used to determine how treatment is affecting food preferences. Free-choice food intake is measured in g and kcal.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Exclusion Criteria:

  • Younger than 25 years old and older than 75 years old at the beginning of the intervention
  • Have body weight less than 110 lbs.
  • Sugar intake at baseline < 11% of total energy consumed
  • Known (self-reported) allergy or adverse reaction to study foods or ingredients
  • Sugar intake at baseline more than 90% of median U.S. sugar 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
  • Use of antibiotics within one month prior to the study
  • 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 (for example, vegetarians)
  • Known taste disorders, including weak or absent sense of taste (screening procedures include a basic taste sensitivity test), abnormal taste in the mouth (e.g., bitter or metallic "phantom" tastes), or other taste abnormality
  • History of taste or smell problems (e.g., weak or absent sense of taste; weak or absent sense of smell)
  • Use of medications within one month prior to the study that moderately to severely affect taste.
  • Volunteers who have lost more than 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 12 months
  • Unable or unwilling to give informed consent or communicate with study staff
  • Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04079855


Contacts
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Contact: David J. Baer, PhD (301) 504-8719 david.baer@usda.gov
Contact: Janet A. Novotny, PhD (301) 504-8263 janet.novotny@usda.gov

Sponsors and Collaborators
David Baer
Monell Chemical Senses Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Paul Wise, PhD Monell Chemical Senses Center

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Responsible Party: David Baer, Supervisory Reserach Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT04079855     History of Changes
Other Study ID Numbers: HS65 - MUTT Study
5U01DC013529 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nutrients
Growth Substances
Physiological Effects of Drugs