Background: Dietary fiber is a key component of a health-promoting diet, and it is acknowledged as a short-fall nutrient in most Western diets. Some sources of dietary fiber, such as hemp hull fiber, also include inherent small molecule bioactives that further promote health and well-being. While dietary fiber is a key component that supports digestive health, it also can cause digestive discomfort. Digestive symptoms such as gas, bloating, belly pain, and the resulting decrease in digestive quality of life are common among adults. The aim of this study was to evaluate changes in digestive comfort, in individuals who currently experience digestive discomfort, after consuming either a proprietary dietary fiber supplement from hemp hull, a dietary fiber supplement made from inulin, or a digestible control (maltodextrin). Methods: This study was a completely virtual, double-blind, placebo-controlled, randomized clinical trial of healthy adults. The parallel arm study tested two fiber supplements at a practical dose yielding a “Good Source of Fiber” based on United States Dietary Reference Intakes (2.8 grams of fiber per day) for six weeks. Results Five hundred seventy nine randomized participants provided follow-up outcomes data. Digestion-associated quality of life questionnaire, belly pain, and gas and bloating scores were assessed and found to be superior after hemp hull fiber intake compared to inulin intake at multiple time points in a post-hoc analysis (p<0.05). Conclusion This study demonstrated that a practical dose of bioactive-rich fiber from hemp hull is well-tolerated, provides superior digestive comfort relative to both placebo and inulin fiber, and can aid in reaching total fiber intake goals.

Objective: This clinical trial investigated the effects of 3-week ingestion of a proprietary gut health supplement containing the bioactives N-trans caffeoyltyramine (NCT) and N-trans feruloyltyramine (NFT), on intestinal barrier function and on severity of GI symptoms in individuals with diarrhea predominant-irritable bowel syndrome (IBS-D). Methods: Participants included 29 males and females diagnosed with IBS-D in accordance with the ROME IV criteria, having lipopolysaccharide (LPS) levels >0.21 ng/ml, and experiencing symptoms related to IBS-D. A randomized, double-blind, placebo-controlled, parallel design was used with 3-week supplementation period with a dietary supplement providing 120mg of NCT and NFT. The primary outcome measure was Lactulose/Mannitol (L/M) ratio, a measure of intestinal permeability. Secondary endpoints included changes in other biomarkers of intestinal permeability (serum LPS, LBP, sCD14, Zonulin, LCN2) and subjective changes in stool frequency and consistency using the Bristol Stool Chart and bloating and abdominal pain using the IBS Symptom Severity Scale (IBS-SSS). Results: The NCT/NFT supplementation group showed significant improvements in L/M ratio (p=0.048), lipopolysaccharide-binding protein (LBP) levels (p=0.018), and the IBS-SSS abdominal distention scores (p=0.044) compared to the placebo group, demonstrating improvement in gut barrier integrity and in GI comfort. No between-group differences were found for other endpoints. No adverse events were reported and study compliance was high. Conclusions: NCT/NFT intake for 3 weeks led to a significant improvement in L/M ratio, LBP and IBS-SSS abdominal distention scores, and a trend for a decrease in abdominal pain scores, thereby demonstrating marked improvement in both objective and subjective outcomes supporting gut barrier function. This propriety gut health supplement shows promise for restoring a healthy gut barrier.