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Vitamin and Mineral Absorption From Milk and PBMAs

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study completion pushed from Dec 30, 2025 to Dec 30, 2026v5
  2. Notable Primary completion date: Dec 30, 2024 to Dec 30, 2025
    • Study completion date: May 30, 2025 to Dec 30, 2025
    v4
  3. Notable Primary completion date: Apr 30, 2024 to Dec 30, 2024v3
  4. Minor Study description revisedv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05898217
Lead Sponsor Clinical Nutrition Research Center, Illinois Institute of Technology
Collaborators: Food and Drug Administration (FDA)
Conditions
(from sponsor)
Nutrition, Healthy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov