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

Adherence, Treatment Clinical Trial

Official title:

Development of a Biomarker to Assess Adherence to Nutrients Supplements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040543
• Other study ID #: 1410234
• Status: Completed
• Phase: N/A
• Start date: July 26, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2020
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Treatment

Intervention

Dietary Supplement:
• lipid-based nutrient supplement containing adherence markers
The supplement will be provided once daily for 10 days
• 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.
• lipid-based nutrient supplement not containing adherence markers
The supplement will be provided once daily for 10 days

Locations

Country	Name	City	State
United States	University of California, Davis	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary concentration of saccharin (nmol/L)		change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
Primary	urinary concentration of saccharin (nmol/g creatinine)		change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15
Primary	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
Primary	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