Protein Powders for Nutrition

Overseen By Gwen Duytschaever

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nimble Science Ltd.

Must not be taking: Antidepressants, Antipsychotics, Antihypertensives, others

Disqualifiers: Gastrointestinal disease, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to understand how the Milk Protein Concentrate/Fast Protein (MCP/FP) investigational product (IP) compares to a control the Micellar Casein Isolate/Slow Protein (MCI/SP) product in healthy volunteers. It involves two phases where participants will try both products. The main goal is to measure the type and rate of amino acids quickly in the small intestine after consuming the protein products and how this relates to gastric emptying.

Will I have to stop taking my current medications?

The trial requires that you do not use regular prescription medications that could affect the study's safety or outcome. If you are taking medications that alter gastrointestinal function, you may need to stop them a week before the study, except for laxatives and proton pump inhibitors, which have specific guidelines. Please consult with the study team for more details.

What data supports the effectiveness of the treatment Micellar Casein Isolate, Milk Protein Concentrate for nutrition?

Research shows that milk protein fractions, like those in micellar casein and milk protein concentrate, have bioactive properties, which means they can have beneficial effects on the body. Additionally, studies indicate that these proteins are highly digestible, which suggests they can be effectively used by the body for nutrition. ^{1 2 3 4 5}

Is milk protein concentrate safe for human consumption?

Milk protein concentrates, including micellar casein, are generally considered safe for human consumption as they are derived from milk, a common dietary component. They are used in various food and beverage products, and no specific safety concerns have been highlighted in the research provided. ^{4 6 7 8 9}

How does the treatment with Micellar Casein Isolate and Milk Protein Concentrate differ from other treatments?

This treatment is unique because it uses micellar casein concentrate (MCC), which is a novel dairy ingredient with high protein content and unique functional properties like foaming and emulsifying. It is produced through microfiltration, which enhances its protein concentration and stability, making it a valuable source for nutritional fortification. ^{2 4 10 11 12}

Eligibility Criteria

This trial is for healthy individuals interested in how their bodies digest different protein powders. Participants will try two types of proteins: a fast-digesting milk concentrate and a slow-digesting casein isolate. Specific eligibility details are not provided, but typically participants should have no major health issues.

Inclusion Criteria

Signed Informed Consent; willing & able to comply with study procedures

Willing to maintain their diet and physical activity levels during the study

I can swallow a large capsule.

Exclusion Criteria

Consumption of probiotic or prebiotic supplements within 1 month prior to screening

Colon cleanses/bowel prep for 2 weeks

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Participants ingest the MCI/SP protein product for their first intervention period

4 weeks

Weekly visits for sample collection and monitoring

Intervention Phase 2

Participants ingest the MPC/FP protein product for their second intervention period

4 weeks

Weekly visits for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Micellar Casein Isolate
• Milk Protein Concentrate

Trial Overview The study compares the digestion of two protein supplements: Milk Protein Concentrate (fast-acting) and Micellar Casein Isolate (slow-acting). Healthy volunteers will consume each product during separate phases to assess amino acid levels and gastric emptying rates.

Participant Groups

Group I: MCI/SP to MPC/FP Active Control 2 Interventions

Participants ingest the MCI/SP protein product for their first intervention period, then MPC/FP for their second intervention period.

Group II: MPC/FP to MCI/SP Active Control 2 Interventions

Participants ingest the MPC/FP protein product for their first intervention period, then MCI/SP for their second intervention period.

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials

11

Recruited

570+

References

1. England pubmed.ncbi.nlm.nih.gov

Bioactive properties and clinical safety of a novel milk protein peptide. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Modified water solubility of milk protein concentrate powders through the application of static high pressure treatment. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Heat markers and quality indexes of industrially heat-treated [15N] milk protein measured in rats. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Production of an 18% protein liquid micellar casein concentrate with a long refrigerated shelf life. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of soluble milk protein or casein supplementation on muscle fatigue following resistance training program: a randomized, double-blind, and placebo-controlled study. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

Thermal stability of reconstituted milk protein concentrates: Effect of partial calcium depletion during membrane filtration. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of dipotassium phosphate addition and heat on proteins and minerals in milk protein beverages. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Invited review: Microfiltration-derived casein and whey proteins from milk. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Influence of milk protein concentrates with modified calcium content on enteral dairy beverage formulations: Physicochemical properties. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Progress in micellar casein concentrate: Production and applications. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Particle Size of Milk Protein Concentrate Powder Affects the Texture of High-Protein Nutrition Bars During Storage. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Utilization of milk proteins as starting materials for other foodstuffs. [2019]