The ingredient, which is branded BioMetaControl, consists of n-trans-Caffeoyl Tyramine (NCT) and n-trans-Feruloyl Tyramine (NFT). Both are potent HNF4-alpha agonists, which Brightseed’s proprietary AI platform, Forager, had identified as a ‘master metabolic switch’ that plays a pivotal role in blood glucose regulation.
NCT and NFT have been tested in vivo and validated for their role in HNF4-alpha agonism, Brightseed said.
Building on those pre-clinical data, the company has also conducted a randomized, double-blind, parallel-arm, clinical study with 126 participants, which it says showed that NCT and NFT administered as BioMetaControl (120 mg per day) demonstrated a statistically significant improvement in fasting blood glucose, fasting insulin and post-meal glucose levels in prediabetic subjects in just 30 days.
The study results have reportedly been submitted to a peer-reviewed journal and are expected to be published in Q4 2025
Swati Kalgaonkar, PhD, head of medical and scientific affairs and clinical research at Brightseed, told NutraIngredients that although the study was designed with the intent of finding statistically significant results, the primary endpoint or biomarker of fasting blood glucose also helps determine if the change was clinically relevant. A clinically relevant change in the biomarkers involves causing an improvement that helps revert from prediabetic state to a normoglycemic state, she explained.
“Our study used a prediabetic population based on that premise, and although we can’t claim that the study subjects reverted to normoglycemia (normal blood glucose levels) given the short study duration, we did show statistically significant improvement in not only FBG, but other related parameters of glucose regulation (fasting insulin, post-meal blood glucose levels and other aspect of continuous blood glucose monitoring),” she said. “Taken together, we can certainly state that the improvements were clinically relevant.”
NCT and NFT
BioMetaControl is built on NCT and NFT, compounds that were previously identified in black pepper but more recently were found in hemp hulls.
The compounds are also used in Brightseed’s Bio Gut Core ingredient, which was previously shown to confer digestive relief benefits emerging in under three weeks at the same 120 mg dose.
Dr. Kalgaonkar said that NCT and NFT are “indeed the same bioactives in Bio Gut Core and BioMetaControl and each ingredient is effective at a dose of 120 mg/d, but the formulation of each ingredient is different. BioMetaControl comes with a sustained release formula, whereas Bio Gut Core does not. The sustained release formula was important for BioMetaControl to allow for the ingredients to be released into circulation at the proper times, enabling these important outcomes.”
According to Brightseed, the sustained-release solution facilitates the ingredient’s inclusion in a range of delivery formats, including capsules, tablets, soft gels or functional beverages.
“BioMetaControl is a pivotal milestone for Brightseed as we expand into metabolic health, building on our foundation in digestive wellness and further proving Forager’s discovery capabilities,” Lee Chae, co-founder and CEO of Brightseed, shared in a press release. “We are excited to provide brands with a clinically proven, nature-powered solution that supports blood glucose control and complements the use of GLP-1 therapies.”
