Adherence, TreatmentNCT04040543
Development of a Marker of Adherence for Tracking Consumption of Nutrient Supplements
A study testing lipid-based nutrient supplement containing adherence markers, lipid-based nutrient supplement containing or not containing adherence markers and lipid-based nutrient supplement not containing adherence markers in people with Adherence, Treatment, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence, Treatment
- What is being tested?
- lipid-based nutrient supplement containing adherence markers, lipid-based nutrient supplement containing or not containing adherence markers and lipid-based nutrient supplement not containing adherence markers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 30 Nov 2020
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-pregnant, non-lactating women
Who cannot join
- BMI <18.5kg/m2 or >25.0 kg/m2
- Diagnosis of chronic disease
- Use of medication that can affect gastrointestinal mobility
- Consumption of more than 7 alcoholic drinks per week
- Smoking
- Unwillingness to refrain from consuming dietary sources of the marker compound(s) 3 days prior to, and during the 12 day urine collection period
Show all 13Show fewer
- Unwillingness to adhere to the study protocol
- Peanut allergy
- Cow milk allergy
- Soy allergy
- Almond allergy
- Allergy to adherence markers
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis
Davis, California, 95616
About this study
Official title: Development of a Biomarker to Assess Adherence to Nutrients Supplements
The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements.
Read the detailed description
The investigators will assess whether urinary concentrations of selected adherence markers can be used to distinguish between daily or intermittent consumption of lipid-based nutrient supplements.
- Conditions
- Adherence, Treatment
- Being tested
- lipid-based nutrient supplement containing adherence markers, lipid-based nutrient supplement containing or not containing adherence markers, lipid-based nutrient supplement not containing adherence markers
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid-based nutrient supplement containing adherence markersDietary supplement
The supplement will be provided once daily for 10 days
lipid-based nutrient supplement containing or not containing adherence markersDietary supplement
The product containing adherence markers will be provided once daily every other day (5 days total); the product not containing adherence markers will be provided on the intervening days for a total of 10 days.
lipid-based nutrient supplement not containing adherence markersDietary supplement
The supplement will be provided once daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Daily | Experimental | Daily supplementation with product containing markers Receives: Dietary Supplement: lipid-based nutrient supplement containing adherence markers |
| Intermittent | Experimental | Daily supplementation with either the product containing markers or the product not containing markers Receives: Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markers |
| Control | Placebo comparator | Daily supplementation with product not containing markers Receives: Dietary Supplement: lipid-based nutrient supplement not containing adherence markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary concentration of saccharin (nmol/L)
Measured: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of saccharin (nmol/g creatinine)
Measured: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of resveratrol metabolites (nmol/L)
resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates
Measured: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of resveratrol metabolites (nmol/g creatnine)
resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates
Measured: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start26 Jul 2019
- Primary completion13 Dec 2019
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, TreatmentStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Marjorie Haskell, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040543
- Sponsor's protocol ID
- 1410234
- Status last verified
- Jan 2021
- First submitted
- 24 Jul 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Biomarker to Assess Adherence to Nutrients Supplements
- ClinicalTrials.gov ID
- NCT04040543
- Acronym / sponsor ID
- 1410234
- Conditions
- Adherence, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 26 Jul 2019 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 31 Jul 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.
The purpose of this study is to determine whether selected adherence markers can be used to track daily or intermittent consumption of nutrient supplements.
Detailed description
The investigators will assess whether urinary concentrations of selected adherence markers can be used to distinguish between daily or intermittent consumption of lipid-based nutrient supplements.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily | Experimental | Dietary Supplement: lipid-based nutrient supplement containing adherence markersDaily supplementation with product containing markers |
| Intermittent | Experimental | Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markersDaily supplementation with either the product containing markers or the product not containing markers |
| Control | Placebo comparator | Dietary Supplement: lipid-based nutrient supplement not containing adherence markersDaily supplementation with product not containing markers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non-pregnant, non-lactating women
Key exclusion criteria (13 listed)
- BMI <18.5kg/m2 or >25.0 kg/m2
- Diagnosis of chronic disease
- Use of medication that can affect gastrointestinal mobility
- Consumption of more than 7 alcoholic drinks per week
- Smoking
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 |
|---|---|---|
| lipid-based nutrient supplement containing adherence markersThe supplement will be provided once daily for 10 days | Dietary supplement | Daily |
| lipid-based nutrient supplement containing or not containing adherence markersThe product containing adherence markers will be provided once daily every other day (5 days total); the product not containing adherence markers will be provided on the intervening days for a total of 10 days. | Dietary supplement | Intermittent |
| lipid-based nutrient supplement not containing adherence markersThe supplement will be provided once daily for 10 days | Dietary supplement | Control |
Primary outcome
urinary concentration of saccharin (nmol/L)
Time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of saccharin (nmol/g creatinine)
Time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
urinary concentration of resveratrol metabolites (nmol/L)
Time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates
urinary concentration of resveratrol metabolites (nmol/g creatnine)
Time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates
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 8 Jan 2021.
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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.
Marjorie Haskell, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipid-based nutrient supplement containing adherence markers, lipid-based nutrient supplement containing or not containing adherence markers and lipid-based nutrient supplement not containing adherence markers in people with Adherence, Treatment, run by University of California, Davis 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 13 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 8 Jan 2021. 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. Some participants in this study may receive a placebo. 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?
urinary concentration of saccharin (nmol/L) (time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15). The study lists 4 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 8 Jan 2021.