Post-menopausal Women, Post-menopausal Status
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWPPC
A chocolate-flavored drink with WPPC added
DIETARY_SUPPLEMENTWhole egg powder
A chocolate-flavored drink with whole egg powder added
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
51 Years to 70 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in circulating choline | Baseline to 10 days | Circulating choline will be measured by UHPLC-HRMS/MS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTKevin Shih
PRINCIPAL_INVESTIGATORBradley Bolling, PhD
University of Wisconsin, Madison
Outcome results
None listed