Vitamin and Mineral Absorption From Milk and PBMAs

Running, not enrolling · Not applicable

Conditions studied: Nutrition, Healthy

In brief

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).

Key facts

Study ID: NCT05898217
Run by: Clinical Nutrition Research Center, Illinois Institute of Technology
People needed: 60
Starts: 2023-06-01
Expected to finish: 2025-12-30
Last updated by the study team: 2025-05-08

Who can join

Age: 25 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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.
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

Where it is running

Clinical Nutrition Research Center Illinois Institute of Technology — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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