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NCT Number: NCT06902480

Dairy Choline Bioavailability

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.

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Key information

Age range

51 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location contact

Bradley Bolling, PhD

PRINCIPAL_INVESTIGATOR

Kevin Shih

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

WPPC

Dietary Supplement

A chocolate-flavored drink with WPPC added

Whole egg powder

Dietary Supplement

A chocolate-flavored drink with whole egg powder added

Primary outcomes

  1. Change in circulating choline

    Time frame: Baseline to 10 days

    Circulating choline will be measured by UHPLC-HRMS/MS

Secondary outcomes

  1. Change in co-factors in circulating choline

    Time frame: Baseline to 10 days

    Co-factors in the circulation will be measured by ultrahigh performance liquid chromatography coupled with high resolution tandem mass spectrometry (UHPLC-HRMS/MS).

  2. Change in high-sensitivity C-reactive protein (hs-CRP)

    Time frame: Baseline to 10 days

    Safety biomarker Hs-CRP will be measured using immunoturbidimetry.

  3. Change in circulating choline metabolites

    Time frame: Baseline to 10 days

    Metabolites will be measured by UHPLC-HRMS/MS.

  4. Change in 8-hydroxydeoxyguanosine

    Time frame: Baseline to 10 days

    The safety biomarker 8-hydroxydeoxyguanosine (8-OHDG) will be measured using enzyme-linked immunosorbent assay (ELISA).

  5. Change in aspartate transaminase

    Time frame: Baseline to 10 days

    Aspartate transaminase (AST) will be measured using kinetic methods.

  6. Change in alanine transaminase (ALT)

    Time frame: Baseline to 10 days

    Alanine transaminase will be measured using kinetic methods.

  7. Change in creatinine

    Time frame: Baseline to 10 days

    Creatinine will be measured using kinetic methods

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Shih

CONTACT

[email protected]

919-338-9453

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2025
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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