Data published in the Journal of Ethnopharmacology indicated that two weeks of supplementation with the botanical blend led to significant improvements in stress levels, gastrointestinal function, and sleep quality in people with constipation.
The study used the branded ingredient Digexin, commercialized by NXT USA. The ingredient was launched at SupplySide West in 2022, and is distributed available in the US and Europe through Freeman Nutra. Digexin is manufactured in India by Laila Nutraceuticals.
Commenting on the new findings, Eric Anderson, Managing Director, NXT USA, said: “We were confident going into this study as historic use and open-label research showed the natural combination that comprises Digexin afforded users tangible benefits of regularity and mood support.
“The mechanism of the product helps support serotonin production, which works to improve mood while promoting speed of digestion, resulting in people feeling more physically and emotionally comfortable.”
Digestive health market
The market for digestive health has been growing impressively in recent years, with several data sources agreeing that the compound annual growth rate (CAGR) for the category is about 7%. Estimates for the global market vary from $8 billion to $10 billion, depending on the data source.
The market is dominated by probiotics, and Anderson told NutraIngredients-USA that NXT USA appreciates all the research around probiotics and their benefits. “Clearly this is a robust category,” he said. “However, we are specialists in herbal extracts so we took an herbal approach to the Gut-Brain Axis, finding ingredients that stimulate serotonin and peristalsis and also soothe the tissues in the gut and help hold onto moisture, promoting regular and complete bowel movements.
“This is a unique approach, one that should complement probiotics - and offer additional support for those who are not finding solutions for their digestive needs from current offerings.”
Commenting on the origin of the name, Anderson told us that Digexin resonated with participants of a focus group with their target audience.
“It’s definitely a nod to the digestive benefits but it also hints at the mood benefits (relaxing the worries of constipation and irregularity). Digexin works on the Gut-Brain Axis and that’s what we are trying to convey,” he said.
The first step in establishing the ingredient for digestive health is to build the science, and the new study offers a proof-of-concept for the safety and efficacy of the blend of Ashwagandha (Withania somnifera (L.) Dunal) and Okra (Abelmoschus esculentus (L.) Moench). Both ingredients are sourced from plants grown in India.
Ashwagandha is an adaptogen that is reported to offer stress management, anti-anxiety, and sleep support benefits. Okra is traditionally used as an herbal medicine for gastrointestinal issues, such as stomach ulcers (the plant’s rhamnogalacturonan polysaccharides reportedly disrupt the adhesion of Helicobacter pylori bacteria in the stomach), as well as for blood sugar and blood lipid management. There are also reports that it offers liver health benefits. HerbalGram has an extensive article on the botanical HERE.
Researchers from Aditya Multi Speciality Hospital in India recruited 48 men and women aged between 25 and 60 to participate in their clinical trial. All participants had functional constipation, according to the established Rome-III criteria. The volunteers were randomly assigned to receive either into placebo, 300 or 500 mg of Digexin for 14 days.
Using a series of questionnaires, including the Patient Assessment of Constipation-Symptoms (PAC-SYM), Patient Assessment of Constipation-Quality of Life (PAC-QOL), and Gastrointestinal Symptom Rating Scale (GSRS), the researchers found that both doses led to improvements in these measures.
Both doses were also associated with improved sleep quality and reduced stress.
Further, supplementation with the higher dose was found to significantly improve serum levels of serotonin, gastrin, IL-6, IL-10, and cortisol.
"These findings demonstrate Digexin’s physical and emotional benefits," said NXT USA’s Anderson. "We just completed the clinical phase of a second human trial affirming these benefits, and which also showed improvements in the speed of transit. After eating a muffin with a special blue dye, study participants noted that transit time was nearly four hours faster in the Digexin group versus the placebo group."
The researchers concluded: “Our trial demonstrates that Digexin supplementation safely and effectively relieved constipation and improved several associated symptoms, such as gastrointestinal function, bowel clearance, stress, sleep, and quality of life of the study volunteers.”
Source: Journal of Ethnopharmacology
Volume 318, Part B, 116997, doi: 10.1016/j.jep.2023.116997
“A blend of Withania somnifera (L.) Dunal root and Abelmoschus esculentus (L.) Moench fruit extracts relieves constipation and improves bowel function: A proof-of-concept clinical investigation”
Authors: R.S. Punukollu et al.