Dairy Choline Bioavailability

University of Wisconsin (UW)

Status: Begins enrollment this month

Conditions: Post-menopausal Status; Post-menopausal Women

Treatments: Dietary Supplement: Whole egg powder; Dietary Supplement: WPPC

Study type: Interventional

Funder types: Other

Identifiers

NCT06902480

2024-1661

CALS/FOOD SCIENCE (Other Identifier)

A074000 (Other Identifier)

Protocol Version 2/24/25 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 51 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Whey Protein Phospholipid Concentrate (WPPC)

Experimental group

Description:

Participants will drink a chocolate-flavored drink with WPPC added

Treatment:

Dietary Supplement: WPPC

Pasteurized whole egg powder

Experimental group

Description:

Participants will drink a chocolate-flavored drink with egg powder added

Treatment:

Dietary Supplement: Whole egg powder