60 Participants Needed

Milk Nutrient Absorption for Nutrition

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Clinical Nutrition Research Center, Illinois Institute of Technology
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications and supplements that could interfere with the study, such as multivitamins, vitamin D, and other dietary supplements. There is a specific 'washout' period (time without taking certain medications) of three weeks for multivitamins and three months for vitamin D supplements before starting the study.

What evidence supports the effectiveness of the treatment for improving nutrient absorption from milk?

Research shows that calcium and vitamin D, components of the treatment, can improve calcium absorption, which is important for bone health. Studies indicate that vitamin D enhances calcium absorption, and calcium from milk is readily absorbed, suggesting that the treatment may help improve nutrient absorption from milk.12345

Is the Milk Nutrient Absorption treatment generally safe for humans?

Research shows that calcium and vitamin D, which are part of the Milk Nutrient Absorption treatment, are generally safe for humans when taken in appropriate amounts. Calcium supplements can cause stomach issues, but serious problems like kidney stones are not commonly linked to them. Vitamin D helps with calcium absorption and is important for bone health.678910

How does the milk nutrient absorption treatment differ from other treatments for nutrient absorption?

This treatment is unique because it leverages the natural components of milk, such as lactose and casein, which enhance the absorption of important minerals like magnesium and calcium, unlike soy-based alternatives that may inhibit absorption. Additionally, milk's specific calcium forms and the presence of casein-phosphopeptide contribute to its superior bioavailability compared to other calcium sources.1112131415

What is the purpose of this trial?

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).

Research Team

CP

Chelsea Preiss

Principal Investigator

Illinois Institute of Technology

Eligibility Criteria

Healthy adults with a BMI of 20-40 kg/m2 and weight ≥110 lbs, not on certain medications (like proton pump inhibitors or anti-inflammatory drugs), non-smokers, and not pregnant. Participants must avoid multivitamins and vitamin-D supplements for three weeks prior to the study, as well as vigorous activity, caffeine, and alcohol before visits.

Inclusion Criteria

I can follow the study's requirements, including diet changes, taking treatments, and attending all visits.
I can avoid hard exercise, caffeine, and alcohol for 24 hours before and during the study visit.
I can keep up with my normal physical activities.
See 6 more

Exclusion Criteria

I have been taking Vitamin D supplements regularly for the last 3 months.
Has a known intolerance or sensitivity to any ingredients in the study products
I haven't used prebiotics, probiotics, drugs for gut movement, or laxatives in the last month.
See 24 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Pre-study

Participants learn how to participate in the trial and schedule their study visits

30 minutes
1 visit (in-person)

Treatment

Participants consume assigned milk or PBMA and undergo blood and urine sampling

1 week
3 visits (in-person)

Follow-up

Participants are monitored for nutrient absorption and safety after treatment

1 week
2 visits (in-person)

Treatment Details

Interventions

  • Calcium
  • Magnesium
  • Potassium
  • Vitamin D
Trial Overview The trial is testing how well nutrients like vitamin D, calcium, potassium, and magnesium are absorbed from cow's milk compared to almond, soy, and oat milks in healthy subjects. Blood samples will be taken after consumption over one week to measure nutrient absorption.
Participant Groups
4Treatment groups
Active Control
Group I: Dairy MilkActive Control1 Intervention
Participants will drink 16 oz of dairy milk daily for the duration of the study.
Group II: Soy MilkActive Control1 Intervention
Participants will drink 16 oz of soy milk daily for the duration of the study.
Group III: Oat MilkActive Control1 Intervention
Participants will drink 16 oz of oat milk daily for the duration of the study.
Group IV: Almond MilkActive Control1 Intervention
Participants will drink 16 oz of almond milk daily for the duration of the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Clinical Nutrition Research Center, Illinois Institute of Technology

Lead Sponsor

Trials
55
Recruited
3,000+

Food and Drug Administration (FDA)

Collaborator

Trials
184
Recruited
1,553,000+

Findings from Research

A study comparing calcium absorption in 15 young and 20 elderly women found that soluble calcium citrate and calcium gluconolactate-carbonate are better absorbed than solid calcium citrate, indicating they may be more effective for treating osteoporosis.
Both young and elderly women showed similar absorption patterns, with soluble forms leading to greater increases in plasma calcium and urinary calcium excretion, suggesting that these forms could be beneficial for improving calcium intake in older adults.
Comparative study of the intestinal absorption of three salts of calcium in young and elderly women.Praet, JP., Peretz, A., Mets, T., et al.[2018]

References

Relative bioavailability of calcium from calcium formate, calcium citrate, and calcium carbonate. [2013]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Vitrum osteomag in prevention of osteoporosis in postmenopausal women: results of the comparative open multicenter trial]. [2016]
Bioavailability of calcium: comparison of calcium carbonate and milk and the effect of vitamin D, age, and sex using 24-hour urine calcium as a method. [2013]
Comparative study of the intestinal absorption of three salts of calcium in young and elderly women. [2018]
Calcium in the diet: food sources, recommended intakes, and nutritional bioavailability. [2019]
Absorption of calcium fumarate salts is equivalent to other calcium salts when measured in the rat model. [2019]
Effect of 1,25-dihydroxyvitamin D3 on calcium and magnesium absorption in the healthy human jejunum and ileum. [2019]
Calcium supplementation in clinical practice: a review of forms, doses, and indications. [2022]
Acute effects of calcium carbonate, calcium citrate and potassium citrate on markers of calcium and bone metabolism in young women. [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Calcium absorption from a new calcium delivery system (CCM). [2019]
Bioavailability of magnesium and calcium from cow's milk and soya-bean beverage in rats. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Quantitative prediction of magnesium absorption in dairy cows. [2013]
13.United Statespubmed.ncbi.nlm.nih.gov
Mineral utilization by rats fed various commercially available calcium supplements or milk. [2018]
[Milk, Daily products and Bone health.Characteristics of calcium in milk.] [2019]
15.United Statespubmed.ncbi.nlm.nih.gov
Absorption of calcium and magnesium from fortified human milk by very low birth weight infants. [2013]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security