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Not yet recruiting NCT06902480

Dairy Choline Bioavailability

No phase Interventional Post-menopausal Women Post-menopausal Status

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WPPC, Whole egg powder.
Who it may be relevant to
Registry conditions: Post-menopausal Women, Post-menopausal Status. Basic parameters: 51 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Dietary supplement WPPC
    A chocolate-flavored drink with WPPC added
  • Dietary supplement Whole egg powder
    A chocolate-flavored drink with whole egg powder added

Primary outcome measures

  • Change in circulating choline [Time frame: Baseline to 10 days]
Secondary outcome measures (7)
  • 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]

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 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Wisconsin - Madison — Madison

Identifiers

NCT: NCT06902480 · 2024-1661 · A074000 · CALS/FOOD SCIENCE · Protocol Version 8/21/25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗