Adherence, Treatment
Conditions
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTlipid-based nutrient supplement containing adherence markers
The supplement will be provided once daily for 10 days
DIETARY_SUPPLEMENTlipid-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.
DIETARY_SUPPLEMENTlipid-based nutrient supplement not containing adherence markers
The supplement will be provided once daily for 10 days
Sponsors
Bill and Melinda Gates Foundation
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary concentration of saccharin (nmol/L) | change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15 | — |
| urinary concentration of saccharin (nmol/g creatinine) | change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15 | — |
| urinary concentration of resveratrol metabolites (nmol/L) | 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) | 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 |
Countries
United States
Outcome results
None listed