Dolcas Biotech’s ginger extract slashes functional dyspepsia symptoms in digestive health trial

14 Jun 2021 --- Dolcas Biotech’s highly concentrated ginger root extract Ginfort has proven effective in reducing a range of functional dyspepsia (FD)-related symptoms in a clinical trial, which found the ingredient eliminated symptoms in over 60 percent of subjects.  

FD is a disorder characterized by symptoms affecting the upper digestive system, including epigastric pain, burning and bloating. 

Created with life science company Olene’s Aqueosome technology, Ginfort is CO2-extracted from the rhizome and is standardized to 26 percent gingeroids, including gingerols and shogaols. 

The extraction technique avoids the volatility caused by heat and storage, which often reduces ginger’s bioavailability.

Ginfort and gut health 
Speaking to NutritionInsight, Dr. Shavon Jackson-Michel, director of medical and scientific affairs at DolCas Biotech, says that while the company was expecting positive results, the scale of the findings came as a surprise. 

“Knowing how concentrated our extract is – as in alignment with what previous research has suggested – we were pleasantly surprised with the magnitude of the results found in the treated group.” 

The FD was planned following Ginfort’s release last year. 

Ginfort’s ability to completely eliminate top FD symptoms in more than 60 percent of subjects, while seeing statistically-significant differences in responder rate/overall treatment efficacy in as few as 14 days in the Ginfort, over placebo group were “exciting results to observe,” says Jackson-Michel.

The study conducted at Maharaja Agrasen Hospital, New Delhi, India, is now published in the Journal of Dietary Supplements. 

Click to EnlargeFD affects close to 20 percent of the global population, with no clear-cut conventional treatment, says Dolcas.Fighting functional dyspepsia
Researchers enlisted 57 participants suffering from FD. They were allocated either 200 mg of Ginfort, twice daily, or an equivalent dose of a dibasic calcium-inactive placebo. 

Treatment efficacy was rated on a seven-point Likert scale where subjects were asked to complete a weekly questionnaire over four weeks. Nine functional dyspepsia-related symptoms were assessed: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, excessive belching, nausea, vomiting and heartburn.

After two weeks, 41 percent of subjects in the Ginfort group reported a statistically significant positive response, which was maintained throughout the trial period. In addition, Ginfort supplementation was found to be effective in 79 percent of the subjects, whereas the placebo was found to be only 21 percent effective. 

After four weeks, the collective elimination score for three major symptoms – postprandial fullness, upper abdominal bloating, and early satiation was 64 percent for Ginfort subjects. 

In contrast, only 13 percent of the placebo group rated their symptoms as eliminated. Most of the nine individual symptoms also showed statistically significant rates of elimination over the placebo group. Examination of blood labs and vital signs determined Ginfort to be an effective and safe option for the treatment of FD.

Ancient medicine, new evidence
Jackson-Michel asserts that despite ginger’s long-standing use in traditional Chinese and Ayurvedic medicine, its beneficial effects on gut health have only been ascribable to formulation with other actives. 

“Ginger’s clinically substantiated value as an herbal standalone, especially in digestive disorders, have previously led to inconclusive results.” 

“The novel Aqueosome technology and solvent-free processing has, for the first time, resulted in real clinical evidence in FD, at some of the lowest doses found in the industry, and this is something that industry should find very exciting,” she says. 

Dolcas Biotech is now looking to further the findings in new research. 

Limitations of the study – including a small to midsize population sampling and lack of reporting of effect size – warrant a follow up study that would seek to corroborate Ginfort’s utility in a larger population, says Jackson-Michel.

“Additionally, an assessment of post-treatment clinical and refractory effects after Ginfort and placebo is stopped would be nice to see evaluated in future studies. Mechanism studies on Ginfort, potentially to understand its role as a prokinetic, to understand the magnitude of serotonin released by neuroendocrine cells of the gut, or other such mechanisms, would also be of interest.”

By Louis Gore-Langton

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