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Protein Supplement

Soy Protein Isolate (SPI) for Healthy Nutrition

N/A
Recruiting
Research Sponsored by University of Guelph
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
Awards & highlights

Study Summary

This trial will compare the effects of dairy vs. soy protein on health. It'll look at fatty acid metabolism, omega-3 fat absorption and blood levels of EPA/DHA to determine whether dairy can improve health.

Who is the study for?
This trial is for healthy adult men and pre-menopausal women who can eat soy and dairy products. Participants should be able to understand the study procedures and communicate with clinical staff.Check my eligibility
What is being tested?
The study is testing whether milk protein (MPI) or soy protein (SPI) affects how our bodies handle omega-3 fatty acids, which are important for health. It will look at blood levels of EPA and DHA, their synthesis, fat oxidation, and absorption from the gut.See study design
What are the potential side effects?
Since this trial involves common foods like milk and soy proteins, side effects may include typical food intolerance symptoms such as digestive discomfort if participants have unknown sensitivities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in plasma EPA and DHA content from baseline
Secondary outcome measures
Change in ALA absorption from balance
Change in EPA and DHA synthesis from baseline
Change in fatty acid oxidation from baseline
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Soy Protein Isolate (SPI)Experimental Treatment1 Intervention
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.
Group II: Milk Protein Isolate (MPI)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Université de SherbrookeOTHER
293 Previous Clinical Trials
69,483 Total Patients Enrolled
University of GuelphLead Sponsor
80 Previous Clinical Trials
9,944 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for this medical trial permitting individuals aged 35 and up?

"At this time, the study is open to participants aged 18 or over and below 45."

Answered by AI

Are any additional participants being accepted into this inquiry?

"The research trial is actively seeking out participants, as per information published on clinicaltrials.gov. It was initially posted on September 1st of 2023 and the details were recently updated December 2nd of 2023."

Answered by AI

How many individuals are enlisted in this research venture?

"Affirmative. Clinicaltrials.gov data suggests that this trial, first posted on September 1st 2023, is now recruiting participants. Currently there are 32 slots open at 2 medical centres."

Answered by AI

Is it possible to take part in this research project?

"32 healthy, educated adults between 18 and 45 years old are being admitted to this medical experiment. These applicants must possess the capability of comprehending procedures involved in the trial as well as conversing with clinical staff; additionally, they should be able to consume soy products and dairy-based edibles."

Answered by AI
~12 spots leftby Aug 2024