Dairy Choline Bioavailability
Assessing Choline Bioavailability and Metabolism From a New Dairy Ingredient for Post-Menopausal Women
4 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
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
March 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 30, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
March 27, 2026
October 1, 2025
9 months
March 24, 2025
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in circulating choline
Circulating choline will be measured by UHPLC-HRMS/MS
Baseline to 10 days
Secondary Outcomes (7)
Change in co-factors in circulating choline
Baseline to 10 days
Change in high-sensitivity C-reactive protein (hs-CRP)
Baseline to 10 days
Change in circulating choline metabolites
Baseline to 10 days
Change in 8-hydroxydeoxyguanosine
Baseline to 10 days
Change in aspartate transaminase
Baseline to 10 days
- +2 more secondary outcomes
Study Arms (2)
Whey Protein Phospholipid Concentrate (WPPC)
EXPERIMENTALParticipants will drink a chocolate-flavored drink with WPPC added
Pasteurized whole egg powder
EXPERIMENTALParticipants will drink a chocolate-flavored drink with egg powder added
Interventions
A chocolate-flavored drink with WPPC added
A chocolate-flavored drink with whole egg powder added
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley Bolling, PhD
University of Wisconsin, Madison
Central Study Contacts
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
March 24, 2025
First Posted
March 30, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
March 27, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- 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.
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.