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

Not Applicable

Completed

• Conditions: Adherence, Treatment
• Interventions: Dietary Supplement: lipid-based nutrient supplement not containing adherence markers; Dietary Supplement: lipid-based nutrient supplement containing adherence markers; Dietary Supplement: lipid-based nutrient supplement containing or not containing adherence markers

• Registration Number: NCT04040543
• Lead Sponsor: University of California, Davis

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.

Study Timeline

• Study First Submitted: 2019-07-24
• Study Start: 2019-07-26
• Study First Submitted QC: 2019-07-30
• Study First Posted: 2019-07-31
• Primary Completion: 2019-12-13
• Study Completion: 2020-11-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	lipid-based nutrient supplement not containing adherence markers	Daily supplementation with product not containing markers
Daily	lipid-based nutrient supplement containing adherence markers	Daily supplementation with product containing markers
Intermittent	lipid-based nutrient supplement containing or not containing adherence markers	Daily supplementation with either the product containing markers or the product not containing markers

Primary Outcome Measures

Name	Time	Method
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 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/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

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Davis, California, United States