Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898217
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-31
First Post:
2023-06-01
Brief Title:
Vitamin and Mineral Absorption From Milk and PBMAs
Sponsor:
Clinical Nutrition Research Center Illinois Institute of Technology
Organization:
Clinical Nutrition Research Center Illinois Institute of Technology
Study Overview
Official Title:
Relative Absorption of Fat-soluble Vitamin D and Minerals From Select Plant-based Milks in Human Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Plant-based milk alternatives PBMAs are a popular alternative to cows 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 cows milk in terms of color they often have a very different nutrition profile In order to better substitute for cows 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 cows 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 cows 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 15 hrs a pick-up visit 30 min one long study day visit 11 hours and two shorter follow up study day visits 1 hr
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 cows 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 cows 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 15 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 cows 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 cows 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 cows 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 cows 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 weeks 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
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 cows 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 cows 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 cows 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 cows 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 weeks 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None