NutritionNCT05898217
Vitamin and Mineral Absorption From Milk and PBMAs
A study testing Dairy Milk, Soy Milk and Almond Milk in people with Nutrition and Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Dairy Milk, Soy Milk and Almond Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Nutrition Research Center Illinois Institute of Technology
Chicago, Illinois, 60616
About this study
Official title: Relative Absorption of Fat-soluble Vitamin D and Minerals From Select Plant-based Milks in Human Subjects
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:
- 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.
- Develop and validate a method for measuring the amount of Vitamin D in blood.
- Develop and validate a method for measuring the amount of magnesium, calcium, and potassium in blood and in urine.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- Being tested
- Dairy Milk, Soy Milk, Almond Milk, Oat Milk
- Keywords
- calcium, vitamin D, potassium, magnesium, dairy, plant-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy MilkOther
Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
Soy MilkOther
Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
Almond MilkOther
Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
Oat MilkOther
Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
| Study group | Role | What they receive |
|---|---|---|
| Dairy Milk | Active comparator | Participants will drink 16 oz of dairy milk daily for the duration of the study. Receives: Other: Dairy Milk |
| Soy Milk | Active comparator | Participants will drink 16 oz of soy milk daily for the duration of the study. Receives: Other: Soy Milk |
| Almond Milk | Active comparator | Participants will drink 16 oz of almond milk daily for the duration of the study. Receives: Other: Almond Milk |
| Oat Milk | Active comparator | Participants will drink 16 oz of oat milk daily for the duration of the study. Receives: Other: Oat Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Collect data from 1 hour to 1 week post-consumption
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.
Measured: Collect data from 1 hour to 1 week post-consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Clinical Nutrition Research Center, Illinois Institute of TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 4 groups, each are assigned to one week of drinking fluid milk, almond milk, soy milk, or oat milk.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Chelsea Preiss, Study director, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898217
- Sponsor's protocol ID
- IRB-2023-83
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Absorption of Fat-soluble Vitamin D and Minerals From Select Plant-based Milks in Human Subjects
- ClinicalTrials.gov ID
- NCT05898217
- Acronym / sponsor ID
- IRB-2023-83
- Keywords
- calcium, vitamin D, potassium, magnesium, dairy, plant-based
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinical Nutrition Research Center, Illinois Institute of TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study has several objectives:
- 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.
- Develop and validate a method for measuring the amount of Vitamin D in blood.
- Develop and validate a method for measuring the amount of magnesium, calcium, and potassium in blood and in urine.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4 groups, each are assigned to one week of drinking fluid milk, almond milk, soy milk, or oat milk.
| Arm | Type | Receives |
|---|---|---|
| Dairy Milk | Active comparator | Other: Dairy MilkParticipants will drink 16 oz of dairy milk daily for the duration of the study. |
| Soy Milk | Active comparator | Other: Soy MilkParticipants will drink 16 oz of soy milk daily for the duration of the study. |
| Almond Milk | Active comparator | Other: Almond MilkParticipants will drink 16 oz of almond milk daily for the duration of the study. |
| Oat Milk | Active comparator | Other: Oat MilkParticipants will drink 16 oz of oat milk daily for the duration of the study. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy MilkDaily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized. | Other | Dairy Milk |
| Soy MilkDaily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized. | Other | Soy Milk |
| Almond MilkDaily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized. | Other | Almond Milk |
| Oat MilkDaily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized. | Other | Oat Milk |
Primary outcome
Concentration of vitamin D in plasma/serum
Time frame: Collect data from 1 hour to 1 week post-consumption
Measure the concentration of blood vitamin D postprandial and after short term (1 week) intake and compare between all arms.
Concentration of calcium, potassium, and magnesium in human serum and urine
Time frame: Collect data from 1 hour to 1 week post-consumption
Measure the concentration of blood and urine calcium, potassium, and magnesium postprandial and after short term (1 week) intake and compare between all arms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chelsea Preiss study director
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy Milk, Soy Milk and Almond Milk in people with Nutrition and Healthy, run by Clinical Nutrition Research Center, Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of vitamin D in plasma/serum (time frame: Collect data from 1 hour to 1 week post-consumption). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.