NCT05898217

Vitamin and Mineral Absorption From Milk and PBMAs

Relative Absorption of Fat-soluble Vitamin D and Minerals From Select Plant-based Milks in Human Subjects

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Nutrition
• Healthy

Interventions

Type	Name	Description
OTHER	Dairy Milk	Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
OTHER	Soy Milk	Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
OTHER	Almond Milk	Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.
OTHER	Oat Milk	Daily, each participant will consume 16 oz of the type of milk (plant based or dairy) two which they are randomized.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-06-12
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States