Healthy DietMUTTNCT04079855
Monell USDA Taste Test Study
A study testing Diet composition 1, Diet composition 2 and Diet composition 3 in people with Healthy Diet, run by David Baer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Diet composition 1, Diet composition 2 and Diet composition 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Exclusion criteria Younger than 25 years old and older than 80 years old at the beginning of the intervention.
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.
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); evaluated using USAUDIT.
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.
Unable or unwilling to give informed consent or communicate with study staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: Diet-induced Modification of Sweet Taste Perception and Preference
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.
Read the 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.
- Conditions
- Healthy Diet
- Being tested
- Diet composition 1, Diet composition 2, Diet composition 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet composition 1Other
A diet with a specified macronutrient composition different from arms 2 and 3.
Diet composition 2Other
A diet with a specified macronutrient composition different from arms 1 and 3.
Diet composition 3Other
A diet with a specified macronutrient composition different from arms 1 and 2, based on the current information about the US macronutrient composition.
| Study group | Role | What they receive |
|---|---|---|
| Diet composition 1 | Experimental | A diet with a specified macronutrient composition different from arms 2 and 3. Receives: Other: Diet composition 1 |
| Diet composition 2 | Experimental | A diet with a specified macronutrient composition different from arms 1 and 3. Receives: 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. Receives: Other: Diet composition 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6
Taste preference
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Measured: Month 1
Taste preference
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Measured: Month 2
Taste preference
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Measured: Month 3
Taste preference
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Measured: Month 4
Taste preference
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Measured: Month 6
Secondary outcomes (2)
Diet-related adverse events
Adverse events related to the diet tabulated by study-arm and severity.
Measured: Daily during the Baseline (Month 1), Months 2-6
Diet-related early discontinuation from intervention
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.
Measured: Daily during the Baseline (Month 1), Months 2-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start15 Jun 2023
- Primary completion9 Aug 2024
- Study completion8 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Baer
- Sponsor type
- US federal agency
- Collaborators
- Monell Chemical Senses Center, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, David Baer, USDA Beltsville Human Nutrition Research Center
- Investigators
- Paul Wise, PhD, Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079855
- Sponsor's protocol ID
- HS65 - MUTT Study
- Other IDs
- 5U01DC013529
- Acronym
- MUTT
- Status last verified
- Jan 2025
- First submitted
- 29 Aug 2019
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet-induced Modification of Sweet Taste Perception and Preference
- ClinicalTrials.gov ID
- NCT04079855
- Acronym / sponsor ID
- MUTT / HS65 - MUTT Study
- Conditions
- Healthy Diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- David BaerUS federal agency
- Collaborators
- Monell Chemical Senses Center, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 8 Aug 2025 (estimated)
- First posted
- 6 Sep 2019 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diet composition 1 | Experimental | Other: Diet composition 1A diet with a specified macronutrient composition different from arms 2 and 3. |
| Diet composition 2 | Experimental | Other: Diet composition 2A diet with a specified macronutrient composition different from arms 1 and 3. |
| Diet composition 3 | Experimental | Other: Diet composition 3A diet with a specified macronutrient composition different from arms 1 and 2, based on the current information about the US macronutrient composition. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet composition 1A diet with a specified macronutrient composition different from arms 2 and 3. | Other | Diet composition 1 |
| Diet composition 2A diet with a specified macronutrient composition different from arms 1 and 3. | Other | Diet composition 2 |
| Diet composition 3A 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 |
Primary outcome
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.
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.
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.
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.
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.
Taste preference
Time frame: Month 1
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Taste preference
Time frame: Month 2
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Taste preference
Time frame: Month 3
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Taste preference
Time frame: Month 4
Most liked concentration. Foods will be scaled as g flavor/100 g food.
Taste preference
Time frame: Month 6
Most liked concentration. Foods will be scaled as g flavor/100 g food.
2 secondary outcomes
Diet-related adverse events
Time frame: Daily during the Baseline (Month 1), Months 2-6
Diet-related early discontinuation from intervention
Time frame: Daily during the Baseline (Month 1), Months 2-6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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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.
Paul Wise, PhD principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet composition 1, Diet composition 2 and Diet composition 3 in people with Healthy Diet, run by David Baer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Taste intensity of food (time frame: Month 1). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.