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

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.

Study Overview

• Status: Completed
• 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

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Daily; Daily supplementation with product containing markers	Dietary supplement: lipid-based nutrient supplement containing adherence markers; The supplement will be provided once daily for 10 days
EXPERIMENTAL: Intermittent; 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; 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.
PLACEBO_COMPARATOR: Control; Daily supplementation with product not containing markers	Dietary supplement: lipid-based nutrient supplement not containing adherence markers; The supplement will be provided once daily for 10 days

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Marjorie Haskell, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2019
• Primary Completion (ACTUAL): December 13, 2019
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 30, 2019
• First Posted (ACTUAL): July 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 1410234

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No