Vitamin and Mineral Absorption From Milk and PBMAs

NCT05898217 | Active Not Recruiting

• 1 other identifier: IRB-2023-83
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Nutrition; Healthy

Keywords

calcium; vitamin D; potassium; magnesium; dairy; plant-based

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Collect data from 1 hour to 1 week post-consumption

Study Arms (4)

Dairy Milk

ACTIVE COMPARATOR

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

Other: Dairy Milk

Soy Milk

ACTIVE COMPARATOR

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

Other: Soy Milk

Almond Milk

ACTIVE COMPARATOR

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

Other: Almond Milk

Oat Milk

ACTIVE COMPARATOR

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

Other: Oat Milk

Interventions

Dairy Milk OTHER

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

Dairy Milk

Soy Milk OTHER

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

Soy Milk

Almond Milk OTHER

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

Almond Milk

Oat Milk OTHER

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

Oat Milk

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Clinical Nutrition Research Center Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Interventions

Milk; Soy Milk

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages; Milk Substitutes; Soy Foods; Vegetable Products; Vegetables

Study Officials

• Chelsea Preiss

  Illinois Institute of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 4 groups, each are assigned to one week of drinking fluid milk, almond milk, soy milk, or oat milk.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 12, 2023
• Study Start: June 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)