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Clinical Trials in the USA / NCT05898217
Active, not recruiting Not applicable

Vitamin and Mineral Absorption From Milk and PBMAs

NCT05898217 · tracked via the Priya Life Science USA tracker
Sponsor
Clinical Nutrition Research Center, Illinois Institute of Technology
Phase
Not applicable
Started
2023-06-01
Last updated
2026-08-28

Condition(s) studied

NutritionHealthy

Investigational drug(s) / intervention(s)

Dairy MilkSoy MilkAlmond MilkOat Milk

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

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

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

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

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).

Eligibility

Sex
ALL
Min age
25 Years
Max age
70 Years
Healthy volunteers
Accepted
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: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Clinical Nutrition Research Center Illinois Institute of Technology Chicago Illinois

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05898217 on ClinicalTrials.gov ↗ ← All trials in the USA