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Starting in 2018, Braini has been working with UNCA, an independent state university to conduct human clinical trials testing Braini supplement formulations. There are severalhuman clinical trials under the control of the Principal Investigator with the aim of publicly reporting the results based onthe online validated CNS Vital Signs cognitive performance testing suite. Currently, there are additional studies underway that are IRB reviewed, double-blinded, andplacebo-controlled and which progress logically from the preceding studies.
With respect to the Principal Investigator, we have not influenced when and how these studies are to be presented and published -- that is at the discretion of the Principal Investigator.
Further, Braini has been tested in open-label (physician observational) trials.
As of October 2020, the controlled clinical trial results are being prepared by the Principal Investigator for peer-reviewed publication which is expected in 2021. People interested in receiving notice of the clinical trial results upon publication should contact us at support@braini.com
Executive Function, correct response reaction time
Healthy subjects aged 50 to 80 years old taking Braini in a University randomized double-blinded placebo-controlled clinical trial improved their executive function correct response reaction time by 66.8 milliseconds in 28 days.
Executive Function, correct response reaction time
Healthy subjects aged 18 to 30 years old taking Braini in a University randomized double-blinded placebo controlled clinical trial improved their executive function scores an average 7.8% over placebo in 28 days.
Physician Observational Trial Data
In a physician’s observational trial healthy subjects who took Braini for 30 to 60 days improved their CNS Vital Signs scores as follows. Individual scores may vary based on individual circumstances.
Braini, the dietary supplement product we make and sell in the USA, was reviewed by FDA's Center for Food Safety and Nutrition. Braini LLC received a letter of no objection from FDA on February 27th, 2020 with a registration #1137 reported into FDA's New Dietary Ingredient Notification (NDIN) database. In the United States, FDA's regulation of the dietary supplement category was originally defined by Congress under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Prior to that, all dietary supplements were regulated as food. The effect of DSHEA was to establish a detailed body of Good Manufacturing Practices (GMPs) by which dietary supplements must be manufactured, packaged, labeled, and stored in order to comply with the law and not be considered adulterated or misbranded. These practices are codified under 21 CFR 111 and includes rules governing structure/function benefit claims that a dietary supplement product may bear on product packaging and advertising.
By the same token, FDA makes it clear that they do not "approve" dietary supplements in the same manner that FDA "approves" drugs. In essence, except for NDIN reviewed submissions, FDA does not "approve" any dietary supplements, however they do aggressively enforce compliance to GMPs and related food safety standards. Here is an excerpt from the online FDA guidance statement on their authority to regulate dietary supplements:
"A firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products." See:https://www.fda.gov/food/
Braini LLC followed FDA's proper procedures for providing evidence to FDA of Braini's safety and effectiveness. That is why Braini LLC received the recent letter of no objection to sell Braini products into commerce.