The Orange Pill Podcast

Episode 32: Efficacy of Probiotic Supplementation for Constipation and Well-being in Older Adults

In this episode, we explore the findings of a newly published clinical trial investigating the impact of an 84-day probiotic regimen on gut and mental health in older adults aged 50–85 who experience occasional constipation. The probiotic blend—Lactiplantibacillus plantarum strains KABP031 and KABP032 (marketed as INNERIM™)—was tested in a randomized, double-blind, placebo-controlled study to evaluate its efficacy and safety.
The results are significant:- Participants taking the probiotic showed increased bowel movement frequency and improved stool consistency as early as Day 42.- By Day 84, they also reported a significant reduction in perceived stress, highlighting a promising link between gut health and emotional well-being.- The probiotic was well-tolerated, with no major side effects, supporting its use as a safe, non-pharmacological option for improving quality of life in older adults.
Join us as we unpack the study’s methodology, key outcomes, and what this means for the future of digestive health, aging, and microbiome-focused interventions. Whether you’re a clinician, researcher, or just curious about how the gut-brain connection works, this episode offers meaningful insights.

Episode 31: Determining Whether Human Research Studies Can Be Conducted Without an IND

 
The FDA’s guidelines on when human research studies require an Investigational New Drug (IND) application can be a maze for researchers and sponsors. In this episode, we break it all down for you: from the broad definition of "drugs" under the FD&C Act to exemptions in clinical investigations. We discuss the core criteria that help you determine if your research falls under the IND requirements and how to avoid common pitfalls.
Whether you’re working with new compounds, marketed drugs, or even live organisms, understanding IND requirements is crucial for safety and regulatory compliance. Tune in now to learn more!

Episode 30: Review of the FDA Bioresearch Monitoring (BIMO) Program

The FDA’s Bioresearch Monitoring (BIMO) program is more than just inspections—it's a regulatory safeguard for the rights and welfare of clinical trial participants and the integrity of data used to support FDA submissions. In this episode, we break down the scope and function of the BIMO program, explore common findings during inspections, and discuss practical strategies for maintaining continuous inspection readiness.
Learn how sponsors, CROs, investigators, IRBs, and testing labs can stay ahead of the curve with proper documentation, monitoring, and mock audits. Ignoring BIMO findings isn’t just risky—it can delay or derail product approval. Listen in for expert insights and actionable tips to help you navigate the BIMO landscape with confidence.

Episode 29: A GOOD IDEA for Better Blood Sugar

In today's episode, we explore a clinically studied nutritional supplement drink made with five amino acids and chromium — shown to reduce post-meal blood sugar levels by up to 25%. We break down the research, the claims, and what it could mean for metabolic health, diabetes prevention, and the supplement industry as a whole. 

Episode 28: Natural Relief- The Science Behind Relieve-R and Its Role in Pain Management

In this episode, we unpack a fascinating clinical trial conducted by KGK Science for LifeSeasons Inc., evaluating the natural health product Relieve-R (formerly Pain Bloc-R) as an alternative for occasional pain relief and inflammation.
Published in the journal Nutrients, this randomized, double-blind, placebo-controlled crossover study compared Relieve-R to acetaminophen and placebo across three 7-day supplementation periods.
The results? Relieve-R significantly reduced pain severity and musculoskeletal discomfort, showing comparable—and in some areas, superior—effectiveness to acetaminophen, all with a favorable safety profile.
We explore what this means for the future of natural pain relief, how the study was designed, and why clinical validation matters in the nutraceutical space.
 

Episode 27: A Novel trial design by KGK Science on Unigen’s UP446 Ingredient to Demonstrate a Positive Immune Defense Response

In this episode, we explore an innovative clinical trial by KGK Science evaluating Unigen’s UP446, a natural health ingredient composed of Acacia catechu and Scutellaria baicalensis. Designed as a randomized, triple-blind, placebo-controlled study, this trial used a human vaccine model to assess immune response following influenza vaccination. 
We discuss the implications of this design, the significance of the findings, and how UP446 may play a vital role in supporting respiratory health—particularly during flu season. Join us as we speak about what this research means for the future of natural health products. 

Episode 26- FDA Continues to Allow Companies to Use NDIs Submitted by Competitors - the Practice of Piggybacking

In this episode on the Orange Pill Podcast, we tackle a long-standing regulatory loophole: piggybacking on NDI submissions. While companies like Natural Alternatives International (NAI) invest in proper safety and regulatory filings, like their recent successful NDI notification for CarnoSyn® beta-alanine, authored by the regulatory team at KGK Science, others sidestep the process entirely.
The FDA’s lack of enforcement has allowed un-notified, and in many cases counterfeit or imported ingredients, to remain on the market, undermining consumer safety and disincentivizing compliance.
We break down:
What piggybacking is and why it’s problematic
The implications of the CarnoSyn® beta-alanine NDI success
NAI’s push for stronger FDA enforcement
How this issue reflects broader weaknesses in DSHEA enforcement
A must-listen for industry professionals, regulatory stakeholders, and anyone invested in the future of dietary supplement safety.

Episode 25: MAHA Commission Report – Big Beautiful (FDA) Blueprint

The MAHA Commission Report is expected to be released today—and it’s already making waves. In this special pre-release episode, we explore what to expect from the report, and how it could reshape conversations around policy, governance, and the future.
As the noise ramps up, we give you the context and clarity you’ll need to navigate the headlines. From structural insights to potential implications, we break it all down before the official release lands.
Get ahead of the narrative. Tune in now.

Episode 24: Nestle Launches Salmon Oil Supplement with Hofseth's OmeGo

In this episode, we explore Nestlé’s U.S. debut of a salmon oil supplement under the Garden of Life brand, featuring OmeGo — a unique whole fish extract by Hofseth Biocare. We break down what makes this omega-3 product stand out in a crowded market, the role of sustainability and full-spectrum benefits, and how KGK Science supported Hofseth in obtaining the crucial NDI status that paved the way for this launch. 
Tune in for an inside look at the intersection of innovation, regulatory success, and industry impact. 

Episode 23: Sustainability: The Future of the Dietary Supplement Industry

As consumer demand grows for clean, conscious products, the supplement industry is being called to evolve.
In this episode, we explore the many ways companies can engage in sustainable sourcing and production—from eco-friendly packaging and ethical ingredient procurement to promoting responsible consumer practices.
Learn how reducing plastic waste, sourcing local or organic ingredients, and embracing circularity can help your brand lead the change—and why it’s no longer optional.