NCT04040543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

July 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

July 24, 2019

Last Update Submit

January 7, 2021

Conditions

Adherence, Treatment

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

Daily

EXPERIMENTAL

Daily supplementation with product containing markers

Dietary Supplement: lipid-based nutrient supplement containing adherence markers

Intermittent

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Daily supplementation with product not containing markers

Dietary Supplement: lipid-based nutrient supplement not containing adherence markers

Interventions

lipid-based nutrient supplement containing adherence markersDIETARY_SUPPLEMENT

The supplement will be provided once daily for 10 days

Daily
lipid-based nutrient supplement containing or not containing adherence markersDIETARY_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.

Intermittent
lipid-based nutrient supplement not containing adherence markersDIETARY_SUPPLEMENT

The supplement will be provided once daily for 10 days

Control

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • non-pregnant, non-lactating women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Marjorie Haskell, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 31, 2019

Study Start

July 26, 2019

Primary Completion

December 13, 2019

Study Completion

November 30, 2020

Last Updated

January 8, 2021

Record last verified: 2021-01

Locations

US(1)