- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05820256
The Effects of Milk Protein Versus Soy Protein on Essential Omega-3 Fatty Acid Metabolism
Investigating the Effects of Milk Protein Versus Soy Protein on Essential Omega-3 Fatty Acid Metabolism: A Randomized Parallel-arm Human Trial in Healthy Canadian Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Direct comparisons between dairy and non-dairy plant-based alternatives on metabolic processes in humans are limiting. The study investigators recently completed a cross-sectional analysis in over 1000 young Canadian adult men and women and reported that the consumption of soy beverages/foods was associated with a reduction in estimated fatty acid desaturase pathway activity compared to milk and dairy food consumption (PMID: 34444977). The fatty acid desaturase pathway controls the endogenous synthesis of beneficial long-chain omega-3 polyunsaturated fatty acids (n3-LCPUFA), such as eicosapentaenoic and docosahexaenoic acids (EPA and DHA), from the essential fatty acid, alpha-linolenic acid (ALA). Epidemiological and clinical studies have reported that higher levels of EPA and DHA in the body are associated with reduced CVD risk. Thus, this prior work identified a previously unrecognized cardio-protective role for dairy that could help to counter consumer misconceptions about dairy increasing cardiovascular disease (CVD) risk.
The primary outcome of this research proposal is to determine if the consumption of dairy protein supports n3-LCPUFA synthesis compared to soy protein. The investigators hypothesize that study participants consuming dairy protein will show a greater conversion of ALA into EPA and DHA via the fatty acid desaturase pathway compared to study participants consuming soy protein. To test this hypothesis, the investigators will conduct a randomized, parallel-arm clinical trial in healthy adult men and women who are consuming either a diet containing milk protein isolate (and no soy) or a diet containing soy protein isolate (and no dairy).
Additional secondary outcomes of interest to further advance understanding of how milk and soy proteins affect acute and chronic ALA metabolism will include:
- Whole blood gene expression analysis of fatty acid desaturases and elongases to determine if milk and soy proteins influence n3-LCPUFA synthesis through a transcriptional mechanism.
- Breath sample analysis to determine if milk and soy proteins influence ALA degradation through β-oxidation.
- An oral fat tolerance test (OFTT) to examine if milk and soy proteins modify ALA absorption from the gut.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David M Mutch, PhD
- Phone Number: 53322 5198244120
- Email: dmutch@uoguelph.ca
Study Contact Backup
- Name: Melanie Plourde, PhD
- Phone Number: 45664 8197802220
- Email: melanie.plourde2@usherbrooke.ca
Study Locations
-
-
Ontario
-
Guelph, Ontario, Canada, N1G2W1
- Not yet recruiting
- University of Guelph
-
Contact:
- David M Mutch, PhD
- Phone Number: 53322 519-824-4120
- Email: dmutch@uoguelph.ca
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 4C4
- Recruiting
- Centre de recherche sur le vieillissement
-
Contact:
- Melanie Plourde, PhD
- Phone Number: 45664 819-780-2220
- Email: melanie.plourde2@usherbrooke.ca
-
Contact:
- David M Mutch, PhD
- Phone Number: 53322 519-824-4120
- Email: dmutch@uoguelph.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy adult men and pre-menopausal women
- Must be able to consume soy and dairy beverages and foods
- Sufficient level of education to understand study procedures and be able to communicate with clinical staff
Exclusion Criteria:
- Diabetic
- Body mass index greater than 35 kg/m2
- Pregnant or lactating
- Neuropsychiatric disorders (major depression, schizophrenia)
- Digestive disorders
- Inflammatory disease
- Cardiovascular disease
- Use of omega-3 supplements within the last 3 months
- Regular consumption of oily fish
- Allergies/sensitivities to dairy and/or soy food products
- Use of lipid-lowering or digestive medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Milk Protein Isolate (MPI)
Study participants in the MPI group will consume 2 smoothies per day for 31 days, where each smoothie provides 300 kcal in total, composed of 45% from carbohydrate (maltodextrin), 20% from protein (milk protein isolate) and 35% from fat (a blend of flaxseed, safflower, and coconut oils).
Each smoothie will be mixed with water up to volume of 250mL.
Individuals in this group will not consume soy-containing beverages and foods during the 31-day study.
|
Study participants will consume two smoothies per day containing a milk protein isolate (MPI) for 31 days.
|
Experimental: Soy Protein Isolate (SPI)
Study participants in the SPI group will consume 2 smoothies per day for 31 days, where each smoothie provides 300 kcal in total, composed of 45% from carbohydrate (maltodextrin), 20% from protein (soy protein isolate) and 35% from fat (a blend of flaxseed, safflower, and coconut oils).
Each smoothie will be mixed with water up to volume of 250mL.
Individuals in this group will not consume dairy-containing beverages and foods during the 31-day study.
|
Study participants will consume two smoothies per day containing a soy protein isolate (SPI) for 31 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma EPA and DHA content from baseline
Time Frame: Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
|
The change in plasma EPA and DHA content from baseline will be determined by using gas chromatography at multiple time points during the 31-day dietary intervention in which study participants consume 2 smoothies per day containing either a milk protein isolate (MPI) or a soy protein isolate (SPI).
|
Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in EPA and DHA synthesis from baseline
Time Frame: Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
|
The 13-C isotopic signature of EPA and DHA will be measured at Day 0 (baseline) using isotope ratio mass spectrometry (IRMS) to determine a baseline signature.
After this baseline measurement, study participants will consume 2 smoothies per day for 31 days containing either SPI or MPI.
From days 15 to 31, the smoothies will contain a small amount of an ALA tracer with a defined 13-C isotopic signature.
The change in EPA and DHA isotopic signatures will be analyzed at multiple time points during the 31-day intervention by IRMS.
|
Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
|
Change in whole blood gene expression from baseline
Time Frame: Measured on days: 0 (baseline) and 31
|
Total RNA will be isolated from fasted whole blood samples collected before and after the 31-day dietary intervention from all study participants using a commercially available kit.
Total RNA will be used to measure the change in expression of fatty acid desaturase and elongase genes (from baseline) by reverse transcriptase quantitative real time PCR (RT-qPCR).
|
Measured on days: 0 (baseline) and 31
|
Change in fatty acid oxidation from baseline
Time Frame: Measured on days: 0 (baseline), 15, 30, and 31
|
The 13-C levels in breath samples will be measured at several time point during the dietary intervention to determine the change in ALA oxidation.
Basal levels of 13-C in the breath will be determined at Days 0 (baseline) and 15.
Starting at Day 15, the daily smoothies consumed by study participants will contain a small amount of an ALA tracer with a defined 13-C isotopic signature.
At the end of the intervention, 13-C levels in breath samples will be measured to determine if either the MPI or SPI altered ALA beta-oxidation.
|
Measured on days: 0 (baseline), 15, 30, and 31
|
Change in ALA absorption from balance
Time Frame: Measured on days: 0 (baseline) and 31
|
An oral fat tolerance test (OFTT) will be used to examine if milk and soy proteins change ALA absorption from the gut.
The OFTT will be conducted on Days 0 (baseline) and 31 (end of study).
Briefly, study participants will consume a standardized liquid emulsion meal containing 50 g fat (from flaxseed oil, which is rich in plant-based omega-3) and either MPI or SPI.
Study participants will consume this liquid meal within 15 minutes.
Blood samples will be collected hourly during the OFTT and ALA content in the chylomicron rich fraction will be measured by gas chromatography.
|
Measured on days: 0 (baseline) and 31
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dietary Proteins and Omega-3s
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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