Diet HabitNCT03501238
Interaction of Salivary Proteins and Polyphenols
A study testing Chocolate Milk, Chocolate milk substitute and Chocolate milk substitute with gelatin in people with Diet Habit and Diet Modification, run by Purdue University at 1 site in United States.
Trial summary
Participants will be chosen through an initial sensory test to find high and low-perceivers of astringency. Selected participants will drink a chocolate milk or milk substitute beverage for one week each with washout weeks in between. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Diet Modification, Taste, Altered
- What is being tested?
- Chocolate Milk, Chocolate milk substitute and Chocolate milk substitute with gelatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2017to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- High or low perceivers of astringency (from initial screening)
Who cannot join
- Current smokers (within 30 days), dairy/nut/cocoa allergies, piercings in mouth, mid-range perceiver of astringency, issues with taste, smell, swallowing or choking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
Participants will be chosen through an initial sensory test to find high and low-perceivers of astringency. Selected participants will drink a chocolate milk or milk substitute beverage for one week each with washout weeks in between. At the end of each week participants will taste and rate multiple beverages for their astringency and other sensory properties. Participants will provide saliva samples weekly for proteomic analysis and (potentially) analysis of polyphenols. Participants will also be asked to provide a 24 hour dietary recall once per week. Data will be analyzed to determine if there is a relationship between polyphenol exposure, astringency ratings, and salivary protein composition.
- Conditions
- Diet Habit, Diet Modification, Taste, Altered, Saliva Altered
- Being tested
- Chocolate Milk, Chocolate milk substitute, Chocolate milk substitute with gelatin
- Medical subject headings
- Feeding Behavior, Dysgeusia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chocolate MilkOther
Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
Chocolate milk substituteOther
Chocolate milk substitute will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
Chocolate milk substitute with gelatinOther
Chocolate milk substitute with gelatin added will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
| Study group | Role | What they receive |
|---|---|---|
| BSG | Experimental | Participant receives bovine milk, then milk substitute, then milk substitute treated with gelatin Receives: Other: Chocolate Milk; Other: Chocolate milk substitute; Other: Chocolate milk substitute with gelatin |
| BGS | Experimental | Participant receives bovine milk, then milk substitute with gelatin, then milk substitute Receives: Other: Chocolate Milk; Other: Chocolate milk substitute; Other: Chocolate milk substitute with gelatin |
| SBG | Experimental | Participant receives milk substitute, then bovine milk, then milk substitute with gelatin. Receives: Other: Chocolate Milk; Other: Chocolate milk substitute; Other: Chocolate milk substitute with gelatin |
| SGB | Experimental | Participant receives milk substitute, then milk substitute with gelatin, then bovine milk Receives: Other: Chocolate Milk; Other: Chocolate milk substitute; Other: Chocolate milk substitute with gelatin |
| GSB | Experimental | Participant receives milk substitute with gelatin, then milk substitute, then bovine milk. Receives: Other: Chocolate Milk; Other: Chocolate milk substitute; Other: Chocolate milk substitute with gelatin |
| GBS | Experimental | Participant receives milk substitute with gelatin, then bovine milk, then milk substitute. Receives: Other: Chocolate Milk; Other: Chocolate milk substitute; Other: Chocolate milk substitute with gelatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative salivary proteins in saliva
Measure relative amounts of salivary proteins in participant saliva.
Measured: 1 year
Secondary outcomes (5)
Subject Diets
Collect participant 24 hour dietary recalls to generate data on eating patterns and dietary choices. Analyze correlations with saliva and sensory ratings. Dietary data that will be analyzed include measures such as: fruit and vegetable intake, fat intake (and type of fat). 24 hour recalls will be assess using the ASHA online tool, which collects data on all foods eaten in the last 24 hours.
Measured: 8 months
Chocolate milk flavor ratings
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate milk. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Measured: 8 months
Chocolate milk substitute flavor ratings
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate almond milk. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Measured: 8 months
Chocolate milk substitute with gelatin flavor ratings
Measure subjects ratings for astringency, bitterness, sweetness, and liking for chocolate almond milk with added gelatin. A generalized visual analog scale will be used, ranging from 0 ("None" for intensity and "Worst ever" for liking) to 100 ("Strongest ever" for intensity and "Best ever" for liking).
Measured: 8 months
Polyphenol content in saliva samples
Measure polyphenol content in expectorated subject saliva samples.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start8 Jun 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cordelia Running, PhD, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501238
- Sponsor's protocol ID
- 082-002
- Status last verified
- May 2023
- First submitted
- 24 May 2017
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction and Modulation of Salivary Proteins With Repeat Exposure to Polyphenols
- ClinicalTrials.gov ID
- NCT03501238
- Acronym / sponsor ID
- 082-002
- Conditions
- Diet Habit, Diet Modification, Taste, Altered, Saliva Altered
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 18 Apr 2018 (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.
Participants will be chosen through an initial sensory test to find high and low-perceivers of astringency. Selected participants will drink a chocolate milk or milk substitute beverage for one week each with washout weeks in between. At the end of each week participants will taste and rate multiple beverages for their astringency and other sensory properties. Participants will provide saliva samples weekly for proteomic analysis and (potentially) analysis of polyphenols. Participants will also be asked to provide a 24 hour dietary recall once per week. Data will be analyzed to determine if there is a relationship between polyphenol exposure, astringency ratings, and salivary protein composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BSG | Experimental | Other: Chocolate Milk, Other: Chocolate milk substitute, Other: Chocolate milk substitute with gelatinParticipant receives bovine milk, then milk substitute, then milk substitute treated with gelatin |
| BGS | Experimental | Other: Chocolate Milk, Other: Chocolate milk substitute, Other: Chocolate milk substitute with gelatinParticipant receives bovine milk, then milk substitute with gelatin, then milk substitute |
| SBG | Experimental | Other: Chocolate Milk, Other: Chocolate milk substitute, Other: Chocolate milk substitute with gelatinParticipant receives milk substitute, then bovine milk, then milk substitute with gelatin. |
| SGB | Experimental | Other: Chocolate Milk, Other: Chocolate milk substitute, Other: Chocolate milk substitute with gelatinParticipant receives milk substitute, then milk substitute with gelatin, then bovine milk |
| GSB | Experimental | Other: Chocolate Milk, Other: Chocolate milk substitute, Other: Chocolate milk substitute with gelatinParticipant receives milk substitute with gelatin, then milk substitute, then bovine milk. |
| GBS | Experimental | Other: Chocolate Milk, Other: Chocolate milk substitute, Other: Chocolate milk substitute with gelatinParticipant receives milk substitute with gelatin, then bovine milk, then milk substitute. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- High or low perceivers of astringency (from initial screening)
Key exclusion criteria (1 listed)
- Current smokers (within 30 days), dairy/nut/cocoa allergies, piercings in mouth, mid-range perceiver of astringency, issues with taste, smell, swallowing or choking.
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 |
|---|---|---|
| Chocolate MilkChocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder. | Other | BGS, BSG, GBS, GSB, SBG, SGB |
| Chocolate milk substituteChocolate milk substitute will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder. | Other | BGS, BSG, GBS, GSB, SBG, SGB |
| Chocolate milk substitute with gelatinChocolate milk substitute with gelatin added will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder. | Other | BGS, BSG, GBS, GSB, SBG, SGB |
Primary outcome
Relative salivary proteins in saliva
Time frame: 1 year
Measure relative amounts of salivary proteins in participant saliva.
5 secondary outcomes
Subject Diets
Time frame: 8 months
Chocolate milk flavor ratings
Time frame: 8 months
Chocolate milk substitute flavor ratings
Time frame: 8 months
Chocolate milk substitute with gelatin flavor ratings
Time frame: 8 months
Polyphenol content in saliva samples
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No. IPD will not be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chocolate Milk, Chocolate milk substitute and Chocolate milk substitute with gelatin in people with Diet Habit and Diet Modification, run by Purdue University 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 25 May 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative salivary proteins in saliva (time frame: 1 year). 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 25 May 2023.