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OpenTrials
Completed

NCT Number: NCT04040543

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

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Key information

Conditions

Adherence, Treatment Behavior Health Behavior Treatment Adherence and Compliance

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lipid-based nutrient supplement containing adherence markers

Dietary Supplement

The supplement will be provided once daily for 10 days

lipid-based nutrient supplement containing or not containing adherence markers

Dietary Supplement

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

Dietary Supplement

The supplement will be provided once daily for 10 days

Primary outcomes

  1. urinary concentration of saccharin (nmol/L)

    Time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15

  2. urinary concentration of saccharin (nmol/g creatinine)

    Time frame: change in concentration between study day 4 (baseline) and study days 7,8,12,13 and 15

  3. urinary concentration of resveratrol metabolites (nmol/L)

    Time frame: 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

  4. urinary concentration of resveratrol metabolites (nmol/g creatnine)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Bill and Melinda Gates Foundation

Registry information

Official study title

Development of a Biomarker to Assess Adherence to Nutrients Supplements

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 31, 2019
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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