Dairy Choline Bioavailability

Assessing Choline Bioavailability and Metabolism From a New Dairy Ingredient for Post-Menopausal Women

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-menopausal Status; Post-menopausal Women
• Intervention / Treatment: Dietary supplement: WPPC; Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kevin Shih; Phone Number: 919-338-9453; Email: sshih22@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin - Madison
      • Principal Investigator: Bradley Bolling, PhD
      • Contact: Kevin Shih; Email: sshih22@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Whey Protein Phospholipid Concentrate (WPPC); Participants will drink a chocolate-flavored drink with WPPC added	Dietary supplement: WPPC; A chocolate-flavored drink with WPPC added
Experimental: Pasteurized whole egg powder; Participants will drink a chocolate-flavored drink with egg powder added	Dietary supplement: Whole egg powder; A chocolate-flavored drink with whole egg powder added

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	Safety biomarker Hs-CRP will be measured using immunoturbidimetry.	Baseline to 10 days
Change in circulating choline metabolites	Metabolites will be measured by UHPLC-HRMS/MS.	Baseline to 10 days
Change in 8-hydroxydeoxyguanosine	The safety biomarker 8-hydroxydeoxyguanosine (8-OHDG) will be measured using enzyme-linked immunosorbent assay (ELISA).	Baseline to 10 days
Change in aspartate transaminase	Aspartate transaminase (AST) will be measured using kinetic methods.	Baseline to 10 days
Change in alanine transaminase (ALT)	Alanine transaminase will be measured using kinetic methods.	Baseline to 10 days
Change in creatinine	Creatinine will be measured using kinetic methods	Baseline to 10 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Bradley Bolling, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-1661; A074000 (Other Identifier: UW Madison); CALS/FOOD SCIENCE (Other Identifier: UW Madison); Protocol Version 8/21/25 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing Time Frame: Anticipated data availability will be immediately following publication. No end date.
• IPD Sharing Access Criteria: Data will be shared with DryAd. The data generated in this study will be housed in DryAd.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No