Beyond herbal medicines: Standardised black seed oil approved for use in dietary supplements in Thailand
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TriNutra announced recently that its cold-pressed black seed (Nigella sativa) oil marketed as ThymoQuin, has received approval from the Thailand Food and Drug Administration as a novel food to be sold in dietary supplements.
The ingredient is standardised to three per cent thymoquinone with less than 1.25 per cent of free fatty acids. The higher the free fatty acids, the higher the acid value, which is an indication of the rancidity of the oil.
“We found that for most of the oil, I would say 90 per cent of the black seed oil cold-pressed, have a very high acid value.
“Acid value is an indication of the rancidity of the oil. A high acid value is in the level of 8 per cent free fatty acid, this is equivalent to about 16 per cent acid value,” said Morris Zelkah, CEO of TriNutra.
He explained that the company had kept the free fatty acids low by controlling the cultivation and the processing condition.
“With this, we can have about 1.25 free fatty acid, which is below 2.5 acid value.”
The ingredient is now available in Thailand via its exclusive distributor Aumento Chemical Ltd.
Black seed oil is traditionally used in Thai herbal medicine for its benefits in digestive health and blood circulation, said Watcharee Saponowong, managing director of Aumento Chemical.
“Black seed oil is one of the recipes in Thai herb medicine formulas. Thai people who are interested in herbal medicine and Thai traditional medicine know it very well.
“Thai tradition mentions that black seed oil is used to improve the digestive system and blood circulation; it can also act as an antimicrobial and antibacterial, and help with dizziness, nausea, faintness, and more,” she said, in response to queries from NutraIngredients-Asia.
The approval of ThymoQuin for use in dietary supplements could help open doors to new product innovation, such as using the ingredient for immune and cardiovascular health supplements, said Zelkah.
“It can maintain a healthy blood pressure in the normal range and for people who are taking medications for blood pressure by supplementation of thymoquinone, they can minimise the dosage of the drugs,” he said, adding that ThymoQuin has a higher bioavailability and thymoquinone levels.
“The other thing is supporting respiration. People who are suffering from asthma can improve their respiration and it also supporting immune and antiviral activity.”
Scientific evidence
The benefits of ThymoQuin in these areas have been demonstrated in human clinical studies.
One of which was a study published in Food Science & Nutrition Research in year 2020.
In the study, 20 middle-aged with normal blood pressure took 500mg of ThymoQuin daily for six weeks. They had a mean systolic blood pressure (SBP) of 143.5mm Hg and diastolic blood pressure (DBP) of 90.7mm Hg at baseline.
Following a three-week washout period, they were then given placebo for another six weeks and blood pressure was measured daily throughout the study.
A significant decrease in blood pressure could be observed after the first six weeks, where their mean SBP decreased 11.2 per cent to 127.3 mm Hg, while mean DBP decreased 12.2 per cent to 79.6 mm Hg.
However, following the three-week washout period and six weeks of placebo use, the mean SBP was slightly elevated back to baseline levels to 131.0 mm Hg, and mean DBP was 77.9 mm Hg.
Another study, also published in Food Science & Nutrition Research last year, showed that marathon runners who consumed 500mg of ThymoQuin daily for four weeks reported significantly fewer upper-respiratory tract complaints, such as cough, sore throat, and sinus congestion, than those who took placebo.
They also had lower cortisol, the stress hormone, and improved microbiome diversity, suggesting that ThymoQuin could improve immune system vigilance and overall well-being following the stress of endurance training and competition.
He added that ThymoQuin could support healthy blood glucose level and promote healthy fats.
“It can support glucose level, support fatty liver, it can bring inflammatory fats to healthy fats. This is very important for people who are suffering from obesity.”
Combination with synergistic ingredients
Other ways of developing new supplement products with ThymoQuin, is to combine it with ingredients such as omega-3 and astaxanthin to produce synergistic effects.
“You can combine black seed oil with a wide range of products. You can combine it with omega-3, lycopene, beta-carotene, lutein, and astaxanthin.
“There is a study that we have for combining Thymoquine with omega-3 and a study where we combine it with astaxanthin,” he said, adding that black seed oil could improve mitochondrial functionality.
Last year, a study published in EC Nutrition showed that male and female runners who took ThymoQuin reported significantly fewer upper-respiratory tract complaints, better overall wellbeing, and higher omega-3 blood levels.
The study involved 35 runners, where they took 500 mg of ThymoQuin and 1,500 mg of fish oil or placebo for four weeks.
“These results demonstrate a significant and meaningful benefit of supplementation with a combination of black cumin seed oil plus fish oil for the immune system as both a “shield” (protection from upper-respiratory complaints) and as a “communication organ” (signalling well-being between body and mind and resulting in superior psychological mood state),” said the researchers.
Another study published in Scholarly Journal of Food and Nutrition last year looked at the use of 500mg ThymoQuin and 8mg astaxanthin versus placebo for four weeks among runners.
Again, those who took ThymoQuin and astaxanthin reported significantly fewer upper respiratory tract complaints and better overall wellbeing.