Dairy Choline Bioavailability for Postmenopausal Health

Overseen By Kevin Shih

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must not be taking: Antibiotics, Probiotics, Laxatives, others

Disqualifiers: Fat malabsorption, Kidney diseases, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the body absorbs choline, an important nutrient, from different sources. It compares a milk-based product called Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to determine if WPPC can provide choline as effectively as eggs. Participants will consume a chocolate-flavored drink containing either WPPC or whole egg powder. Postmenopausal women with a stable body weight for six months may be suitable candidates. As an unphased trial, this study allows participants to contribute to significant nutritional research that could influence dietary recommendations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you regularly use antibiotics, probiotics, prebiotics, Orlistat, Cetilistat, or laxatives, or if you are undergoing hormone replacement therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Whey Protein Phospholipid Concentrate (WPPC) is generally safe for healthy individuals. One study found that moderate amounts of whey protein, a component of WPPC, do not affect liver function unless pre-existing liver problems are present. Thus, it is considered safe for most people without liver issues.

Whole egg powder is also well-tolerated and provides choline, a nutrient that the body absorbs easily. No specific evidence indicates harmful effects from whole egg powder, making it a safe choice for most individuals.

These treatments are not new drugs, so they do not undergo the same approval process as new medications. Their general safety suggests suitability for this study. It is always advisable to consult a healthcare provider if there are any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical supplements or hormone therapies for postmenopausal health, these treatments use natural ingredients like WPPC and whole egg powder to boost choline intake. Researchers are excited about these options because choline plays a crucial role in brain and liver health, which are areas of concern for postmenopausal women. The unique delivery method—a tasty chocolate-flavored drink—makes it easy and enjoyable to consume, potentially improving adherence compared to pills or capsules.

What evidence suggests that this trial's treatments could be effective for postmenopausal health?

Studies have shown that whole egg powder is a good source of choline because it contains choline in a natural form that the body can absorb easily. Eating whole eggs has been linked to better choline levels and improved diet quality. In this trial, participants will receive either whole egg powder or Whey Protein Phospholipid Concentrate (WPPC) to assess their choline benefits. Researchers are studying WPPC to determine if it can provide the same choline benefits as eggs. While whey protein, like WPPC, may help meet nutritional needs, its ability to provide choline is still being compared to that of whole eggs. This trial tests both options to determine which better supports health in postmenopausal women. ^{2 3 6 7 8}

Who Is on the Research Team?

Bradley Bolling, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for postmenopausal individuals interested in understanding how their bodies use choline, a nutrient important for liver function, brain development, and muscle movement. Participants should be healthy with no major dietary restrictions that would prevent them from consuming dairy or eggs.

Inclusion Criteria

I do not have chronic kidney disease.

I am willing to drink chocolate-flavored study drinks.

I am between 51 and 70 years old.

Exclusion Criteria

On weight loss/weight gain diets

I have been diagnosed with chronic kidney disease.

I regularly use laxatives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants consume a chocolate-flavored drink mixed with either WPPC or whole egg powder to assess choline bioavailability and metabolism

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whole egg powder
• WPPC

Trial Overview The study is testing the effectiveness of Whey Protein Phospholipid Concentrate (WPPC), a dairy product, against whole egg powder in providing choline to the body. Participants will consume a chocolate-flavored drink containing one of these ingredients to see which one improves choline metabolism better.

How Is the Trial Designed?

Group I: Whey Protein Phospholipid Concentrate (WPPC) Experimental Treatment 1 Intervention

Participants will drink a chocolate-flavored drink with WPPC added

Group II: Pasteurized whole egg powder Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06902480?term=AREA%5BConditionSearch%5D(Choline)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=3

Study Details | NCT06902480 | Dairy Choline Bioavailability The intent of the evaluation is to improve the knowledge of how WPPC contributes to the nutritional needs and health of postmenopausal women. Official Title.

2. withpower.com withpower.com/trial/phase-post-menopausal-women-4-2025-7b200

Dairy Choline Bioavailability for Postmenopausal Health Trial Overview The study is testing the effectiveness of Whey Protein Phospholipid Concentrate (WPPC), a dairy product, against whole egg powder in providing ...

3. ctv.veeva.com ctv.veeva.com/study/dairy-choline-bioavailability

Dairy Choline Bioavailability - ClinicalTrials.Veeva Researchers will compare Whey Protein Phospholipid Concentrate (WPPC) to whole egg powder to see if WPPC is as effective as eggs.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9572824/

Effect of Whey Protein Supplementation in ... In postmenopausal women, WP supplementation only in combination with RT enhances BC and LLLM compared to placebo controls. Without RT, WP has no significant ...

5. clinconnect.io clinconnect.io/trials/NCT06902480

Dairy Choline Bioavailability (NCT06902480) - ClinConnect This clinical trial, called "Dairy Choline Bioavailability," is exploring whether dairy products, specifically a type of whey protein, are as good a source of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06902480?term=EGG%20PHOSPHOLIPIDS&rank=5

Study Details | NCT06902480 | Dairy Choline Bioavailability 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10815430/

Investigating the Health Implications of Whey Protein ... Moderate WP intake does not harm liver function in healthy individuals. Caution advised for pre-existing liver conditions. Generally safe for ...

8. mdpi.com mdpi.com/2624-862X/3/2/22

Glycoproteomic and Lipidomic Characterization of ... This work investigates the composition of whey protein phospholipid concentrate (WPPC), an underutilized dairy stream, and reveals that it is a source of many ...