Dairy Choline Bioavailability

Not Applicable

Not yet recruiting

• Conditions: Post-menopausal Women; Post-menopausal Status

• Registration Number: NCT06902480
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-30
• Study Start: 2025-06
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

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 records
• Willing to consume the chocolate-flavored 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, fish, peanut, shellfish, soy, tree nuts, wheat, crustaceans, gluten, mollusks, mustard, sesame seeds.)
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in circulating choline	Baseline to 10 days	Circulating choline will be measured by UHPLC-HRMS/MS

Secondary Outcome Measures

Name	Time	Method
Change in co-factors in circulating choline	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).
Change in high-sensitivity C-reactive protein (hs-CRP)	Baseline to 10 days	Safety biomarker Hs-CRP will be measured using immunoturbidimetry.
Change in circulating choline metabolites	Baseline to 10 days	Metabolites will be measured by UHPLC-HRMS/MS.
Change in 8-hydroxydeoxyguanosine	Baseline to 10 days	The safety biomarker 8-hydroxydeoxyguanosine (8-OHDG) will be measured using enzyme-linked immunosorbent assay (ELISA).
Change in aspartate transaminase	Baseline to 10 days	Aspartate transaminase (AST) will be measured using kinetic methods.
Change in alanine transaminase (ALT)	Baseline to 10 days	Alanine transaminase will be measured using kinetic methods.
Change in creatinine	Baseline to 10 days	Creatinine will be measured using kinetic methods

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States