Post-menopausal WomenNCT06902480
Dairy Choline Bioavailability
A study testing WPPC and Whole egg powder in people with Post-menopausal Women and Post-menopausal Status, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 51 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-menopausal Women, Post-menopausal Status
- What is being tested?
- WPPC and Whole egg powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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 smoothies
- Willing to provide blood, urine, fecal samples at baseline and after 10 days of intervention
Who cannot join
- 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
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- Regularly using weight-loss drugs (GLP-1, Orlistat, Cetilistat, etc.)
- Regularly using laxatives
- Unable to avoid strenuous exercise during the study (>4 h vigorous exercise per day)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Kevin Shih, sshih22@wisc.edu
Bradley Bolling, PhD
About this study
Official title: 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 smoothie mixed with either WPPC or whole egg powder.
Read the 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.
- Conditions
- Post-menopausal Women, Post-menopausal Status
- Being tested
- WPPC, Whole egg powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WPPCDietary supplement
A chocolate-flavored smoothie with WPPC added
Whole egg powderDietary supplement
A chocolate-flavored smoothie with whole egg powder added
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein Phospholipid Concentrate (WPPC) | Experimental | Participants will drink a chocolate-flavored smoothie with WPPC added Receives: Dietary Supplement: WPPC |
| Pasteurized whole egg powder | Experimental | Participants will drink a chocolate-flavored smoothie with egg powder added Receives: Dietary Supplement: Whole egg powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circulating choline
Circulating choline will be measured by UHPLC-HRMS/MS
Measured: Baseline to 10 days
Secondary outcomes (7)
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).
Measured: Baseline to 10 days
Change in high-sensitivity C-reactive protein (hs-CRP)
Safety biomarker Hs-CRP will be measured using immunoturbidimetry.
Measured: Baseline to 10 days
Change in circulating choline metabolites
Metabolites will be measured by UHPLC-HRMS/MS.
Measured: Baseline to 10 days
Change in 8-hydroxydeoxyguanosine
The safety biomarker 8-hydroxydeoxyguanosine (8-OHDG) will be measured using enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline to 10 days
Change in aspartate transaminase
Aspartate transaminase (AST) will be measured using kinetic methods.
Measured: Baseline to 10 days
Change in alanine transaminase (ALT)
Alanine transaminase will be measured using kinetic methods.
Measured: Baseline to 10 days
Change in creatinine
Creatinine will be measured using kinetic methods
Measured: Baseline to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start18 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-menopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Bolling, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902480
- Sponsor's protocol ID
- 2024-1661
- Other IDs
- A074000, CALS/FOOD SCIENCE, Protocol Version 4/24/2026
- Status last verified
- Aug 2026
- First submitted
- 24 Mar 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Choline Bioavailability and Metabolism From a New Dairy Ingredient for Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT06902480
- Acronym / sponsor ID
- 2024-1661
- Conditions
- Post-menopausal Women, Post-menopausal Status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 smoothie 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein Phospholipid Concentrate (WPPC) | Experimental | Dietary Supplement: WPPCParticipants will drink a chocolate-flavored smoothie with WPPC added |
| Pasteurized whole egg powder | Experimental | Dietary Supplement: Whole egg powderParticipants will drink a chocolate-flavored smoothie with egg powder added |
Who may qualify
- Ages
- 51 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WPPCA chocolate-flavored smoothie with WPPC added | Dietary supplement | Whey Protein Phospholipid Concentrate (WPPC) |
| Whole egg powderA chocolate-flavored smoothie with whole egg powder added | Dietary supplement | Pasteurized whole egg powder |
Primary outcome
Change in circulating choline
Time frame: Baseline to 10 days
Circulating choline will be measured by UHPLC-HRMS/MS
7 secondary outcomes
Change in co-factors in circulating choline
Time frame: Baseline to 10 days
Change in high-sensitivity C-reactive protein (hs-CRP)
Time frame: Baseline to 10 days
Change in circulating choline metabolites
Time frame: Baseline to 10 days
Change in 8-hydroxydeoxyguanosine
Time frame: Baseline to 10 days
Change in aspartate transaminase
Time frame: Baseline to 10 days
Change in alanine transaminase (ALT)
Time frame: Baseline to 10 days
Change in creatinine
Time frame: Baseline to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradley Bolling, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WPPC and Whole egg powder in people with Post-menopausal Women and Post-menopausal Status, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Shih (919-338-9453, sshih22@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating choline (time frame: Baseline to 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.