CClinicalTrials.gg
Active, not recruitingNCT05898217Updated Aug 28, 2026

Vitamin and Mineral Absorption From Milk and PBMAs

An interventional study of Dairy Milk and Soy Milk in Nutrition and Healthy, sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology. Active, not recruiting at 1 site in United States. Open to participants aged 25 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by Clinical Nutrition Research Center, Illinois Institute of Technology · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study summary

Plant-based milk alternatives (PBMAs) are a popular alternative to cow's milk. The different types of PBMAs on the market shelf include almond, oat, soy, coconut, cashew, pea, hemp, and rice. Among these, PBMA made from almonds, oats and soy are the most popular in North America. Though PBMAs are designed to mimic cow's milk in terms of color, they often have a very different nutrition profile. In order to better substitute for cow's milk, PBMAs often have added vitamins and minerals, as well as added sugars and flavorings to improve flavor.

This study will test how well certain nutrients (vitamin D, calcium, potassium, and magnesium) are absorbed by the body after intake of milk and PBMAs. Nutrient absorption will be measured using blood samples after short term intake (from 1 hours to 1 week) of almond, soy, and oat milk, and compare it to cow's milk. Participants in the study will avoid all fluid dairy products and vitamin-D supplemented foods for three weeks and then be asked to consume either almond, soy, oat, or cow's milk for one week.

All participants will visit the Clinical Nutrition Research Center (CNRC) four times over the course of about one month. These visits include a screening and pre-study visit (1.5 hrs), a pick-up visit (30 min), one long study day visit (\~11 hours), and two shorter follow up study day visits (1 hr).

Read the detailed description

The study has several objectives:

  1. The main objective is to conduct a short-term research trial to understand the relative absorption of key micronutrients (Vitamin D, calcium, potassium and magnesium) from select PBMAs.
  2. Develop and validate a method for measuring the amount of Vitamin D in blood.
  3. Develop and validate a method for measuring the amount of magnesium, calcium, and potassium in blood and in urine.
  4. Compare the amount of vitamin D and minerals in blood of people assigned to drink cow's milk to people who those assigned to drink plant-based milk alternatives.

This study will test how well certain nutrients (Vitamin D, calcium, potassium, and magnesium) are absorbed by the body after intake. We will examine nutrient absorption after short term intake (from 1 hour to 1 week) of almond, soy, and oat milk, and compare it to cow's milk. Participants in the study will avoid all fluid dairy products and any dairy or foods fortified with vitamin D for three weeks and then will be asked to consume either almond, soy, oat, or cow's milk for one week. All participants will visit the Clinical Nutrition Research Center (CNRC) at least five times over the course of about one month. The visits will proceed as follows:

  1. Participants will come to IIT Mies campus for a screening visit. Blood pressure, blood sugar via finger prick, and anthropometric measurements (height, weight, body composition) will be taken. Women under age 60 will be asked for urine sample for pregnancy test. Participants who qualify will stay an additional 30 minutes for a prestudy visit where they will learn how to participate in the trial and schedule their study visits.
  2. Standardized dinner pick up visit - participants will come to the IIT Mies campus to pick up a standardized dinner meal to eat before their Study Day 1 visit.
  3. Study Day 1 Visit - Participants will have a catheter placed and a baseline blood draw will be performed. Participants will be randomized to one of four groups (almond milk, soy milk, oat milk, or cow's milk) and will drink 480 mL (16 oz) of that beverage. After the drink, blood will be collected via the catheter after 1 hour, 2 hours and then every 2 hours until hour 10. After 6 hours, participants will be given a light meal to alleviate hunger before the catheter is removed. Every hour, participants will be provided with 150 mL of distilled water to drink and urine will be collected after each blood draw. In total 50 mL of blood will be taken over the course of the day. After completing the study day, participants will be provided with a week's supply of the PBMA or milk and will be asked to drink 8 oz of the beverage 2x per day over the course of the following week while avoiding other dairy products.
  4. Study Day 2 Visit: Participants will return to the IIT Mies campus 24 hours after the start of their Visit 1 and after a 10-12 hour fast. Anthropometric measurements, blood pressure, and blood sugar will be taken again. Then, 6 mL of blood will be drawn and urine collection will be performed.
  5. Study Day 3 Visit: One week after Study Day Visit 1, participants will return to IIT Mies Campus. Anthropometric measurements, blood pressure, and blood sugar will be taken. Then, a fasting blood draw and urine collection will be performed. After fasting blood draw, participants will be given a snack. Total blood drawn will be 6 mL.

The blood and urine samples will be analyzed for specific nutrients and compared between the four randomized groups.

02

Conditions studied

  • Nutrition
  • Healthy

Keywords

  • calcium
  • vitamin D
  • potassium
  • magnesium
  • dairy
  • plant-based
03

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI of 20.0-40.0 kg/m2, inclusive and a weight ≥ 110 lb. at the screening visit.
  • Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 12 months)
  • Judged to be in good health on the basis of the medical history i.e., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
  • Not taking any medications that would interfere with outcomes of the study, i.e. proton pump inhibitors, anti-inflammatory drugs, antibiotics, vitamin D
  • Willing to discontinue any multivitamin, vitamin or mineral supplements for three weeks immediately after date of the screening
  • Able to provide informed consent
  • Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and GI tract questionnaire, sample collection procedures and study visit schedule)
  • Able to maintain usual physical activity pattern
  • Able to avoid vigorous physical activity, caffeine, and alcohol for 24 hours prior to and during study visit

Exclusion criteria

Exclusion Criteria:

  • Men and women who smoke or vape (including marijuana)
  • Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
  • Men and women who have blood pressure >160 mmHg (systolic)/100 mmHg (diastolic) at screening visit
  • Men and women who have fasting blood glucose concentration >125 mg/dL at screening visit
  • Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
  • Men and women with history of weight loss surgery or intestinal surgery which can impact digestion
  • Men and women with osteoporosis
  • Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
  • Women who are known to be pregnant or who are intending to become pregnant over the course of the study
  • Women who are lactating
  • Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g.,multivitamin, B complex supplement. Subjects may choose to go off dietary supplements (requires three week washout for multivitamin, three months for vitamin D supplements) before beginning the study.
  • Men and women who have participated in prebiotics or laxative trial within 3 months prior to enrollment or any other clinical trial within 1 month
  • Men and women who have regularly taken Vitamin D supplements in the past 3 months
  • Major trauma or a surgical event within 2 months or longer depending on trauma or event and after consultation with PI.
  • Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator.
  • Has a known intolerance or sensitivity to any ingredients in the study products
  • Has used antibiotics within the previous 2 months
  • Had colonoscopy within 3 months
  • Has used prebiotics, probiotics, or drugs active on gastrointestinal motility, or a laxative of any class within 1 month
  • History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
  • Substance (alcohol or drug) abuse within the last 2 years
  • Excessive coffee and tea consumers (> 4 cups/d)
  • Donated blood within last 3 months
  • Men and women who do excessive exercise regularly or are an athlete
  • Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
  • Women who are taking unstable dose and brand of hormonal contraceptives and/or stable dose and brand less than 6 months
  • Unusual working hours i.e., working overnight (e.g. 3rd shift
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Dairy Milk

    Participants will drink 16 oz of dairy milk daily for the duration of the study.

    Other: Dairy Milk

  • Active comparator
    Soy Milk

    Participants will drink 16 oz of soy milk daily for the duration of the study.

    Other: Soy Milk

  • Active comparator
    Almond Milk

    Participants will drink 16 oz of almond milk daily for the duration of the study.

    Other: Almond Milk

  • Active comparator
    Oat Milk

    Participants will drink 16 oz of oat milk daily for the duration of the study.

    Other: Oat Milk

Interventions

  • OtherDairy Milk

    Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.

  • OtherSoy Milk

    Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.

  • OtherAlmond Milk

    Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.

  • OtherOat Milk

    Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.

05

What researchers measure

Primary outcomes

  1. Concentration of vitamin D in plasma/serum

    Measure the concentration of blood vitamin D postprandial and after short term (1 week) intake and compare between all arms.

    Time frame: Collect data from 1 hour to 1 week post-consumption

  2. Concentration of calcium, potassium, and magnesium in human serum and urine

    Measure the concentration of blood and urine calcium, potassium, and magnesium postprandial and after short term (1 week) intake and compare between all arms.

    Time frame: Collect data from 1 hour to 1 week post-consumption

06

Study locations

1 site
  • Clinical Nutrition Research Center Illinois Institute of Technology
    Chicago, Illinois 60616, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05898217
Lead sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborators
Food and Drug Administration (FDA)
Responsible party
Sponsor
First posted
Jun 12, 2023
Start date
Jun 1, 2023
Primary completion
Dec 30, 2025
Completion
Dec 30, 2026 (estimated)
Last update
Aug 28, 2026

Study contacts

Chelsea Preiss
study director · Illinois Institute of Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion