Clinical trial NCT06902480: Dairy Choline Bioavailability
Official title: Assessing Choline Bioavailability and Metabolism From a New Dairy Ingredient for Post-Menopausal Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post-menopausal Women
Post-menopausal Status
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 24
Sex: FEMALE
Minimum age (years): 51
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in circulating choline
timeFrame: Baseline to 10 days
Secondary outcomes:
measure: Change in co-factors in circulating choline
timeFrame: Baseline to 10 days
measure: Change in high-sensitivity C-reactive protein (hs-CRP)
timeFrame: Baseline to 10 days
measure: Change in circulating choline metabolites
timeFrame: Baseline to 10 days
measure: Change in 8-hydroxydeoxyguanosine
timeFrame: Baseline to 10 days
measure: Change in aspartate transaminase
timeFrame: Baseline to 10 days
measure: Change in alanine transaminase (ALT)
timeFrame: Baseline to 10 days
measure: Change in creatinine
timeFrame: Baseline to 10 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Bradley Bolling, PhD
role: PRINCIPAL_INVESTIGATOR
References: