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What does “clinically proven” mean?

Vanilla shake

Protiva is clinically proven to improve nutritional status. But what does that mean?

Protiva can improve your nutritional status during pregnancy and breastfeeding. How do we know that? Because Protiva is the first and only nutritional shake to have completed a clinical study approved by an institutional review board.

“Clinical study,” you might say, “that sounds impressive! But what does it mean for the product? And why does an institutional review board matter?”

Great questions.

The nutritional and health claims you see on packaging and advertising can be confusing—or outright misleading—and consumers have become rightly skeptical of the scientific-sounding language used in product promotion. So please let us walk you through these terms and explain how Protiva has been proven to be effective.

What’s a clinical study?

A clinical study is a type of research that tests how well a product or treatment works. Clinical studies are structured to isolate testing variables and to reduce or eliminate researcher bias.
For instance, testing may involve a “blind” experiment in which information about the test is masked from the participant or researchers until after the trial is complete, or a “placebo” experiment whereby a control group receives an inactive drug or treatment.

What is an institutional review board?

Clinical studies are reviewed by institutional review boards (IRBs). The purpose of an IRB is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects in a research study. These boards must have at least five members and must reflect a diversity of backgrounds (not just doctors), specialties (not just OB/GYNs), and gender (not exclusively male or female). IRBs must also have at least one member who is not affiliated with the institution directly or through a family member.

So what happened in Protiva’s clinical study?

The IRB approved Protiva clinical study was performed over seven months at multiple sites in California. The study included 120 female patients, including “blinds.” Participants had their blood drawn to monitor protein levels while pregnant, recovering from delivery, and breastfeeding. Dr. Leon J Baginski at Mission Medical Group was the principal investigator.

At the beginning of the study, nearly 85% of the pregnant women had low protein levels or below normal protein levels during their second and third trimester of pregnancy. After taking Protiva, 100% of the women achieved normal protein levels and maintained them while they remained on Protiva.

And what does that mean?

That means that Protiva is clinically proven to improve protein levels during pregnancy and breastfeeding. This is important because maintaining optimal protein levels is critical for the development of your baby, especially in the third trimester. Protiva can also help new moms heal from delivery, while providing the additional protein and vitamins they need when lactating.

We hope this answers all of your questions! Feel free to email us if we missed anything

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