Dairy Choline Bioavailability | NCT06902480

Studies
Dairy Choline Bioavailability

NCT06902480

Sponsor

University of Wisconsin, Madison

Status

Not yet recruiting

Last Update Posted

Jun 1, 2026Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Post-menopausal Women
Post-menopausal Status

Interventions

WPPC
Whole egg powder

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
A074000	Other Identifier	UW Madison
CALS/FOOD SCIENCE	Other Identifier	UW Madison
Protocol Version 8/21/25	Other Identifier	UW Madison

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2026Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Mar 24, 2025

First Submission Date that Met QC Criteria

Mar 24, 2025

First Posted Date

Mar 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to find out if dairy is a good source of choline compared to eggs. The main questions it aims to answer are:

How the body uses choline; and,
What effect WPPC has on choline metabolism.

Researchers will compare Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to see if WPPC is as effective as eggs.

Participants will drink a chocolate-flavored drink mixed with either WPPC or whole egg powder.

Detailed Description

This study is intended to evaluate the bioavailability and metabolism of choline in WPPC compared to the most commonly -used food for bioavailable choline, whole egg. The intent of the evaluation is to improve the knowledge of how WPPC contributes to the nutritional needs and health of postmenopausal women.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Whey Protein Phospholipid Concentrate (WPPC)	Experimental	Participants will drink a chocolate-flavored drink with WPPC added	Dietary Supplement: WPPC
Pasteurized whole egg powder	Experimental	Participants will drink a chocolate-flavored drink with egg powder added	Dietary Supplement: Whole egg powder

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WPPC	Dietary Supplement	A chocolate-flavored drink with WPPC added	Whey Protein Phospholipid Concentrate (WPPC)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in circulating choline	Circulating choline will be measured by UHPLC-HRMS/MS	Baseline to 10 days

Secondary Outcomes

Measure	Description	Time Frame
Change in co-factors in circulating choline	Co-factors in the circulation will be measured by ultrahigh performance liquid chromatography coupled with high resolution tandem mass spectrometry (UHPLC-HRMS/MS).	Baseline to 10 days
Change in high-sensitivity C-reactive protein (hs-CRP)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ages between 51 and 70
Is currently post-menopausal (Post-menopausal is a term used to describe the time in a woman's life after she has gone through menopause. This usually happens between the ages of 45 and 55. Menopause is when a woman's menstrual periods stop permanently (at least 12 months))
Not allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)
Had stable body weight (± 5%) for the past 6 months
Free from cancer
Did not have weight loss surgery, colon surgery
Do not have chronic kidney diseases
Do not have malabsorption towards fat and dairy products
Willing to complete health surveys
Willing to complete two 4-day food diaries
Willing to consume the intervention beverages
Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention

Exclusion Criteria:

On weight loss/weight gain diets
Diagnosed with fat malabsorption
Undergoing weight loss surgery
Diagnosed with chronic kidney diseases
Allergic to the intervention foods and allergens that are related to the production of intervention foods (e.g. dairy products, egg, chocolate, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds, banana, strawberry, raspberry, blackberry, blueberry.)
Regularly using antibiotics or probiotics or prebiotics
Regularly using Orlistat or Cetilistat
Regularly using laxatives
Undergoing hormone replacement therapy, or receiving hormones in any forms
Unable to avoid strenuous exercise during the study (>4 h intense exercise per day)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

51 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Kevin Shih	Contact	919-338-9453		sshih22@wisc.edu

Name	Affiliation	Role
Bradley Bolling, PhD	University of Wisconsin, Madison	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin - Madison		Madison	Wisconsin	53705	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The research team will share the individual participant data collected during the trial after deidentification. Deidentified data will be stored and shared with DryAd and in accordance with all applicable regulations.

Types

Not provided

Time Frame

Anticipated data availability will be immediately following publication. No end date.

Access Criteria

Data will be shared with DryAd. The data generated in this study will be housed in DryAd.

URL

https://datadryad.org/