Development of a Marker of Adherence for Tracking Consumption of Nutrient Supplements

NCT ID: NCT04040543

Last Updated: 2021-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-26

Study Completion Date

2020-11-30

Brief Summary

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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

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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

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Adherence, Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Daily

Daily supplementation with product containing markers

Group Type EXPERIMENTAL

lipid-based nutrient supplement containing adherence markers

Intervention Type DIETARY_SUPPLEMENT

The supplement will be provided once daily for 10 days

Intermittent

Daily supplementation with either the product containing markers or the product not containing markers

Group Type EXPERIMENTAL

lipid-based nutrient supplement containing or not containing adherence markers

Intervention Type DIETARY_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.

Control

Daily supplementation with product not containing markers

Group Type PLACEBO_COMPARATOR

lipid-based nutrient supplement not containing adherence markers

Intervention Type DIETARY_SUPPLEMENT

The supplement will be provided once daily for 10 days

Interventions

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lipid-based nutrient supplement containing adherence markers

The supplement will be provided once daily for 10 days

Intervention Type DIETARY_SUPPLEMENT

lipid-based nutrient supplement containing or not containing adherence markers

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.

Intervention Type DIETARY_SUPPLEMENT

lipid-based nutrient supplement not containing adherence markers

The supplement will be provided once daily for 10 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* non-pregnant, non-lactating women

Exclusion Criteria

* 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
* Unwillingness to adhere to the study protocol
* Peanut allergy
* Cow milk allergy
* Soy allergy
* Almond allergy
* Allergy to adherence markers
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marjorie Haskell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

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University of California, Davis

Davis, California, United States

Site Status

Countries

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United States

Other Identifiers

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1410234

Identifier Type: -

Identifier Source: org_study_id

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