Nutrition, HealthyNCT05820256
The Effects of Milk Protein Versus Soy Protein on Essential Omega-3 Fatty Acid Metabolism
A study testing Milk Protein Isolate (MPI) and Soy Protein Isolate (SPI) in people with Nutrition, Healthy, run by University of Guelph at 2 sites in Canada.
Trial summary
Dairy products provide macronutrients, vitamins, and minerals that are important for health and development. Despite this, many Canadians now eat fewer dairy products and are instead consuming more non-dairy alternatives, such as soy. Some of this is because of misconceptions about the effects of dairy on health. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Milk Protein Isolate (MPI) and Soy Protein Isolate (SPI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Diabetic
- Body mass index greater than 35 kg/m2
- Pregnant or lactating
- Neuropsychiatric disorders (major depression, schizophrenia)
- Digestive disorders
- Inflammatory disease
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Guelph
Guelph, Ontario, N1G2W1
Centre de recherche sur le vieillissement
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: 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
Dairy products provide macronutrients, vitamins, and minerals that are important for health and development. Despite this, many Canadians now eat fewer dairy products and are instead consuming more non-dairy alternatives, such as soy. Some of this is because of misconceptions about the effects of dairy on health. However, the study investigators hypothesize that, compared to soy, dairy may actually improve a person's health due to its effects on the enzymes in the body that make omega-3 fatty acids, such as EPA and DHA. The goal of this study is to examine omega-3 metabolism in men and women consuming either milk or soy protein. Briefly, this study will determine if the consumption of milk or soy protein differentially impacts blood EPA and DHA levels, the synthesis of EPA and DHA, fatty acid oxidation, and omega-3 fat absorption from the gut. It is anticipated that the findings from this novel and innovative research project will provide high quality evidence to support a previously unappreciated protective effect of dairy for human health and development.
Read the 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.
- Conditions
- Nutrition, Healthy
- Being tested
- Milk Protein Isolate (MPI), Soy Protein Isolate (SPI)
- Keywords
- omega-3 metabolism, ALA, EPA, DHA, fatty acid desaturase, fat oxidation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk Protein Isolate (MPI)Dietary supplement
Study participants will consume two smoothies per day containing a milk protein isolate (MPI) for 31 days.
Soy Protein Isolate (SPI)Dietary supplement
Study participants will consume two smoothies per day containing a soy protein isolate (SPI) for 31 days.
| Study group | Role | What they receive |
|---|---|---|
| Milk Protein Isolate (MPI) | Experimental | 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. Receives: Dietary Supplement: Milk Protein Isolate (MPI) |
| Soy Protein Isolate (SPI) | Experimental | 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. Receives: Dietary Supplement: Soy Protein Isolate (SPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma EPA and DHA content from baseline
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: Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
Secondary outcomes (4)
Change in EPA and DHA synthesis from baseline
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: Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
Change in whole blood gene expression from baseline
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: Measured on days: 0 (baseline) and 31
Change in fatty acid oxidation from baseline
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: Measured on days: 0 (baseline), 15, 30, and 31
Change in ALA absorption from balance
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: Measured on days: 0 (baseline) and 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 Sep 2023
- Primary completion18 Sep 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be block randomized by gender into one of two groups for a parallel-arm trial.
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke
- Responsible party
- Principal investigator, David M Mutch, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820256
- Sponsor's protocol ID
- Dietary Proteins and Omega-3s
- Status last verified
- Dec 2024
- First submitted
- 3 Apr 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be anonymized.
Publications
Gonzalez-Soto M, Abdelmagid SA, Ma DWL, El-Sohemy A, Mutch DM. Soy Consumption, but Not Dairy Consumption, Is Inversely Associated with Fatty Acid Desaturase Activity in Young Adults. Nutrients. 2021 Aug 17;13(8):2817. doi: 10.3390/nu13082817.
PubMed 34444977
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05820256
- Acronym / sponsor ID
- Dietary Proteins and Omega-3s
- Conditions
- Nutrition, Healthy
- Keywords
- omega-3 metabolism, ALA, EPA, DHA, fatty acid desaturase, fat oxidation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- Université de Sherbrooke
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dairy products provide macronutrients, vitamins, and minerals that are important for health and development. Despite this, many Canadians now eat fewer dairy products and are instead consuming more non-dairy alternatives, such as soy. Some of this is because of misconceptions about the effects of dairy on health. However, the study investigators hypothesize that, compared to soy, dairy may actually improve a person's health due to its effects on the enzymes in the body that make omega-3 fatty acids, such as EPA and DHA. The goal of this study is to examine omega-3 metabolism in men and women consuming either milk or soy protein. Briefly, this study will determine if the consumption of milk or soy protein differentially impacts blood EPA and DHA levels, the synthesis of EPA and DHA, fatty acid oxidation, and omega-3 fat absorption from the gut. It is anticipated that the findings from this novel and innovative research project will provide high quality evidence to support a previously unappreciated protective effect of dairy for human health and development.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be block randomized by gender into one of two groups for a parallel-arm trial.
| Arm | Type | Receives |
|---|---|---|
| Milk Protein Isolate (MPI) | Experimental | Dietary Supplement: 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. |
| Soy Protein Isolate (SPI) | Experimental | Dietary Supplement: 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Diabetic
- Body mass index greater than 35 kg/m2
- Pregnant or lactating
- Neuropsychiatric disorders (major depression, schizophrenia)
- Digestive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk Protein Isolate (MPI)Study participants will consume two smoothies per day containing a milk protein isolate (MPI) for 31 days. | Dietary supplement | Milk Protein Isolate (MPI) |
| Soy Protein Isolate (SPI)Study participants will consume two smoothies per day containing a soy protein isolate (SPI) for 31 days. | Dietary supplement | Soy Protein Isolate (SPI) |
Primary outcome
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).
4 secondary outcomes
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
Change in whole blood gene expression from baseline
Time frame: 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
Change in ALA absorption from balance
Time frame: Measured on days: 0 (baseline) and 31
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Background: PubMed 34444977Gonzalez-Soto M, Abdelmagid SA, Ma DWL, El-Sohemy A, Mutch DM. Soy Consumption, but Not Dairy Consumption, Is Inversely Associated with Fatty Acid Desaturase Activity in Young Adults. Nutrients. 2021 Aug 17;13(8):2817. doi: 10.3390/nu13082817.
- Individual participant dataSharing planned: No. Individual participant data will be anonymized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk Protein Isolate (MPI) and Soy Protein Isolate (SPI) in people with Nutrition, Healthy, run by University of Guelph at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.