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

Study Overview
=================
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.

Official Title
-----------------
Development of a Biomarker to Assess Adherence to Nutrients Supplements

Conditions
-----------------
Adherence, Treatment

Intervention / Treatment
-----------------
* Dietary Supplement: lipid-based nutrient supplement containing adherence markers
* Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markers
* Dietary Supplement: lipid-based nutrient supplement not containing adherence markers


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily<br>Daily supplementation with product containing markers | Dietary Supplement: lipid-based nutrient supplement containing adherence markers<br>* The supplement will be provided once daily for 10 days<br>|
| Experimental: Intermittent<br>Daily supplementation with either the product containing markers or the product not containing markers | Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markers<br>* 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.<br>|
| Placebo Comparator: Control<br>Daily supplementation with product not containing markers | Dietary Supplement: lipid-based nutrient supplement not containing adherence markers<br>* The supplement will be provided once daily for 10 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | resveratrol metabolites may include resveratrol glucuronides and/or resveratrol sulfates | 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 | change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15 |