Supporting

Research

Supporting Research

^The following were extracted from clinical studies and are for referencing purpose only. This does not imply that the product is claimed to treat, cure or prevent any disease.

^The following were extracted from clinical studies and are for referencing purpose only. This does not imply that the product is claimed to treat, cure or prevent any disease.

1.) Support healthy blood glucose levels

Mulberry leaves have been used widely in Asia to treat various diseases including high blood glucose level. Many studies have showed that mulberry leaf extract is effective in supporting healthy fasting blood glucose and reducing fluctuating post-meal blood glucose level.

High fasting blood glucose levels suggest that the body has been unable to reduce the levels of glucose in the blood. If left untreated, high glucose levels in the blood for prolonged period can lead to serious health problems such as damage to the blood vessels. This would in turn increase the risk of heart disease, stroke, kidney disease, vision and nerve problems.

Study 1:

In this study, a total of 17 type-2 diabetic patients on single or combined therapy were orally administered either standardised 1000 mg of mulberry leaf extract (MLE) or placebo, 3 times daily with meal for 3 months. The change in the A1c and self-monitoring blood glucose (SMBG) were assessed. A significant reduction of the postprandial SMBG was observed at 3 months in the MLE group compared to the baseline (16.1%, p< 0.05). When compared to placebo, the MLE has a significant improvement in the post-prandial SMBG (18.2%, p< 0.05). A decrease of A1c was observed from 7.30% at baseline to 6.94% in the MLE-treated group (p= 0.079). No difference in A1c was observed between the MLE and placebo groups. Hence, this suggests that mulberry leaf could reduce the post-meal glucose level in diabetic patients.Mulberry leaves reduce the post-prandial blood glucose levels.

Study 2:

In a clinical study, 37 healthy adults with normal blood glucose levels were orally administered either 3 doses of mulberry-extract (ME) or placebo while being co-administered with 50g maltodextrin. The 3 doses of mulberry-extract include normal dose (12.5mg DNJ), half dose (6.75mg DNJ) and double dose (25mg DNJ). The blood glucose and insulin levels of both groups were then determined.

Compared to the placebo group, the difference in the positive incremental Area Under the Curve (pIAUC) (glucose (mmol/L x h)) were observed for half dose ME was -6.1% (-18.2%, 5.9%; p= 0.316), normal dose ME was -14.0% (-26.0%, -2.0%; p = 0.022) and double dose ME was -22.0% (-33.9%, – 10.0%; p<0.001).

Meanwhile, the difference in the pIAUC (insulin (mIU/L x h) when compared to placebo for half dose ME was -9.7% (-25.8%, 6.3%; p = 0.234), for normal dose ME was -23.8% (-39.9%, -7.8%; p = 0.004) and double dose ME was -24.7% (-40.8%, -8.6%; p = 0.003). Hence, this study suggests that mulberry leaf extract is able to reduce the total blood glucose increment after the ingestion of maltodextrin 120 minutes later.

Study 3:

In this animal test, mice were made to fast for 24 hours before their blood glucose levels were measured at different time points. Results showed that LactoSpore® Bacillus coagulans significantly reduced fasting blood glucose levels.

Study 4:

Recent clinical trials demonstrated that α-glucosidase inhibitor helps reduce the progression of impaired glucose tolerance to type 2 diabetes, suggesting the potential application of α-glucosidase inhibitor as a preventive and therapeutic agent for type 2 diabetes and its complications. Mulberry leaf has been shown to have strong α-glucosidase inhibitory activity, attributed to its bioactive compound known as 1-deoxynojirimycin (DNJ).

In a 38-day clinical trial, the effect of DNJ-enriched (1.5%) mulberry leaf extract on postprandial glycemic control was evaluated by oral sucrose tolerance test. Administration of 0.8 g of the powder, which corresponds to 12 mg DNJ per day, resulted in significant suppression of postprandial blood glucose elevation and insulin secretion. No adverse events, including hypoglycemia, abnormal lipid profiles were observed during and after the study period. These findings suggest the potential use of DNJ-enriched mulberry leaf extract in improving postprandial glycemic control in pre-diabetic as well as mild diabetic individuals.

2.) Support cardiovascular health

Cardiovascular disease (CVD) is the result of higher than normal serum cholesterol levels. Medicines such as statins have been widely used for the treatment of high cholesterol levels by the inhibition of de novo cholesterol synthesis. Despite being an effective medicine for hyperlipidemia, it is costly and associated with many negative side effects.

Mulberry was found to improve the heart health by the reduction of cholesterol and blood pressure levels in some research. It helps to prevent atherosclerosis, one of the main conditions that contributes to health diseases. Atherosclerosis is the build-up of plaque in the arteries, causing blood flow in the blood vessels to be disrupted and subsequently develop into heart diseases.

Study 1:

In this study, 23 non-diabetic patients with mild dyslipidaemia were orally administered with 3 tablets of 280mg of mulberry leaf tablet 3 times daily before meals over 12 weeks. Their blood lipid parameters and liver function tests were taken routinely every 4 weeks. Significant reductions of triglycerides from baseline were observed at week 4 was 10.2% (p<0.05) and week 8 was 12.5% (p<0.05) respectively after the mulberry leaf tablet therapy. At the end of the 12-week therapy, there was significant decrease in total cholesterol, triglyceride and LDL from the baseline by 4.9% (p<0.05), 14.1% (p<0.05) and 5.6% (p<0.05), respectively. Meanwhile, for HDL, a significant increase by 19.7% (p<0.05) from the baseline was observed. Thus, the findings from this study suggest that mulberry leaf is capable of reducing the (bad) cholesterol but increase the HDL levels in patients with mild dyslipidaemia.

Study 2:

In this animal test, animals were fed a cholesterol-rich diet and cholesterol measurement taken after 14 days of feeding was used as positive control. Subsequently, LactoSpore® Bacillus coagulans was administered for 40 days and the cholesterol levels were measured at various time points. Administration of LactoSpore(R) reduced blood cholesterol levels.This suggests that LactoSpore® helps mitigate the diet-induced hypercholesterolemia.

Study 3:

To evaluate the in vitro cholesterol-lowering activity of LactoSpore® Bacillus coagulans, the probiotics were cultured in a media supplemented with cholesterol. The remaining cholesterol levels were assessed after 24 hours. LactoSpore® B. coagulans significantly reduced cholesterol levels in the culture media regardless whether they were in growing, resting and even heat-killed states. In addition, this probiotic also significantly reduced the cholesterol levels in cholesterol-rich foods – egg yolk, chicken liver and butter, when incubated for 24 hours in conditions mimicking the in vivo environment. It is worth noting that B. coagulans also produced significant amounts of propionic acid and butyric acid, while fermenting the cholesterol-rich foods. These major short-chain fatty acids provide colon cells with energy, enhance mineral absorption, reduce inflammation and improve intestinal health.

3.) Support gastrointestinal health

a) Manage diarrhoea 
Diarrhoea refers to a condition of passing loose or watery stools 3 or more times in a day, or more frequently than usual. It can cause one to lose fluids quickly and increase the risk of dehydration and fatigue. A chronic bout of diarrhoea could be attributed to an imbalanced gut flora. When bad bacteria outnumber the good bacteria in the gut, the digestive tract is no longer able to function normally, this could result in diarrhoea. Research has shown that taking probiotics may help prevent and treat diarrhoea, by repopulating good bacteria in the gut and modulating an imbalanced gut microbiota. Diarrhoea could also be due to rapid movement of food through the intestines (hypermotility), resulting in inadequate time for sufficient nutrients and water to be absorbed. LactoSpore® Bacillus coagulans has been research proven to have anti-diarrhoeal activity and reduce intestinal motility in subjects experiencing diarrhoea.

In this animal test, male rats were orally given castor oil (1 ml / animal) to induce diarrhoea, followed by oral administration of 40, 80 and 160 x 106 cfu / kg body weight of LactoSpore® B. coagulans spores respectively. The weight of faecal samples collected from the castor-oil induced diarrhoea was recorded at 4, 8 and 12 hours and gastrointestinal motility of fasting rats was assessed by calculating the distance covered by the charcoal meal in the intestine. LactoSpore® B. coagulans demonstrated dose-dependent anti-diarrhoeal activity and suppression of gastrointestinal motility in the rats. This suggests that LactoSpore® B. coagulans could be a potential agent in the management of diarrhoea.

b) Manage diarrhoea-predominant IBS

Irritable bowel syndrome (IBS) is a common disorder that affects the digestive tract. The symptoms include diarrhoea, constipation and stomach cramps which recur over time and can last for days, weeks or even months at a time. IBS is a lifelong problem without any cure but it can be managed with a healthy, balanced diet. Restoring balance of gut flora via probiotic supplementation helps relieve IBS symptoms by suppressing the growth of harmful bacteria and reducing inflammation. LactoSpore® B. coagulans is a versatile probiotic strain which can withstand acidity in the stomach and is activated in the intestines to modulate the gut microbiota.

In this clinical trial, patients receiving standard care of treatment for diarrhoea-predominant irritable bowel syndrome (IBS) were orally administered with a placebo or LactoSpore® (containing 2 x 109 cfu B. coagulans) as a dietary supplement in addition to standard treatment for 90 days. An interval of at least 4 hours was kept between the placebo or LactoSpore® and standard care of treatment. Clinical symptoms of IBS were evaluated using Physician Global Assessment and IBS-Quality of Life (IBS-QOL) questionnaires. Visual Analog Scale (VAS) was used to evaluate abdominal pain.

The group which was administered LactoSpore® showed a significant decrease in the clinical symptoms, including diarrhoea, bloating, abdominal pain, vomiting and stool frequency compared to the placebo group. The LactoSpore® group also showed a decrease in severity of IBS via Physician Global Assessment and better quality of life via IBS-QOL. Both placebo and LactoSpore® groups showed normal clinical range of laboratory parameters, anthropometric and vital signs, suggesting that LactoSpore® is safe for human consumption as a dietary supplement. It also demonstrates significant efficacy in the management of diarrhoea-predominant IBS.

c) Manage depression associated with irritable bowel syndrome (IBS)

The symptoms of IBS include abdominal pain, diarrhoea, constipation, bloating or gas, these can cause distress that is similar to depression. Some patients are worried about a flare-up of diarrhoea or constipation and would avoid going to work, school or socialising with friends and gradually lose interest in activities they once enjoyed. They also tend to feel irritable and restless. These emotional distress could worsen the IBS symptoms as patients may feel it is hopeless to improve their diet to ease gastrointestinal symptoms.

In a clinical trial, 40 patients diagnosed with major depressive disorder (MDD) with IBS were orally administered either a placebo or LactoSpore® B. coagulans, at a daily dose of 2 x 109 cfu (2 billion spores) for 90 days. The changes from baseline in clinical symptoms of MDD and IBS were evaluated using questionnaire which includes Hamilton Rating Scale for Depression (HAM-D), Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) and Gastrointestinal Discomfort Questionnaire (GI-DQ).

Oral administration of LactoSpore® B. coagulans resulted in significant improvement to HAM-D, IBS- QQL and GI-DQ sores in the group which were administered LactoSpore® B. coagulans, compared to the placebo group. In addition, it was also observed that the serum myeloperoxidase, an inflammatory biomarker for inflammatory bowel disease also significantly decreased at the end of the study, compared to baseline. All the safety parameters are within normal clinical range and there is no clinically significant difference between baseline and at the end of the study. These findings suggest the safety and efficacy of LactoSpore® B. coagulans for major depressive disorder in IBS patients.

d) Reduce colon inflammation (colitis)

Colitis refers to inflammation of the inner lining of the colon, which is typically manifested as abdominal pain, cramping and diarrhoea with or without blood in the stool. There is no known cure to date. Colitis is believed to be caused by an imbalance between intestinal microbiota and mucosal immunity, which results in excessive intestinal inflammation.

In this animal test, mice were given Dextran Sulfate Sodium (DSS) (3.5%) in drinking water for 20 days to induce colitis. Oral administration of LactoSpore® Bacillus coagulans reducing colonic shortening. This is shown by longer colon length in the LactoSpore® group, compared to the Control group. Shortening of colon length in DSS-induced mice is one of the biological markers in the assessment of colonic inflammation. In addition, administration of LactoSpore® also increased the survival rate of the mice with DSS-induced colitis. These findings suggest the beneficial effects of LactoSpore® on individuals suffering from colitis or colon inflammation.

4.) Support healthy weight management

4) Support healthy weight management

According to World Health Organisation (WHO), worldwide obesity rate has approximately tripled since 1975. In 2016, 39% of adults aged 18 years and above were overweight and 13% were obese. In obesity, triglycerides and LDL (bad) cholesterol tend to be high and HDL (good) cholesterol tends to be low. This would increase the risk of cardiovascular diseases, including heart attack and stroke.

Obesity is preventable, restricting carbohydrate intake is an option for persons seeking to lose weight and reduce cardiovascular risk factors. A study has shown that a low-carbohydrate diet was more effective than low-fat diet in lowering body weight and cardiovascular risk. In addition to dietary modifications, probiotics also has significant beneficial effects on lipid metabolism and weight loss. LactoSpore®, a resilient probiotic has been research proven to support healthy weight and lipid profile.

Study 1:
In this clinical trial, 49 participants received freshly prepared mostly vegan meals (breakfast, lunch, and dinner) that included 1200 to 1400 daily calories for women and 1600 to 1800 (daily calories for men. In this 21-day weight loss programme, nutritional supplements containing enzymes and cleanse supplementation and probiotic supplementation with LactoSpore® Bacillus coagulans were orally administered to the participants. It was observed that post-intervention resulted in clinically meaningful reductions in body weight, total cholesterol and LDL (bad) cholesterol, suggesting LactoSpore® Bacillus coagulans’ potential to be included into weight loss regimen.

Study 2:
In this study, high-fat-diet-induced obese (DIO) mice were treated with mulberry leaves for over 13 weeks. Six mice respectively were fed a low-fat diet (LFD consisting of 10% calories from fat), high fat diet (HFD consisting of 60% calories from fat) and mulberry leaf diet (M + HFD consisting of 20%
mulberry leaf powder (w/w) added into a balanced HFD with 60% calories from fat). Over 13 weeks, significant weight loss (p<0.01) was observed in the DIO mice with mulberry leaves from the 8th week. However, no significant difference in the energy intake was observed between the HFD group and the M + HFD groups. Mulberry leaves were also found to reduce the fat accumulation and fat/body weight ratio (p < 0.05) significantly. Thus, it can be said that mulberry leaves can effectively reduce weight.

5.) Support strong immunity

4) Support healthy weight management

Probiotics protect against pathogens by inducing their direct killing, improving gut barrier function that keeps out harmful microorganisms and stimulating the response of the gut-associated immune repertoire. Phagocytosis, a process by which immune cells ingest or engulf pathogens, is a major
mechanism used to remove pathogens.

In this in vitro study, the phagocytic activity was determined by adopting a model of synthetic microspheres based on 2-hydroxyethyl methacrylate using peripheral blood cells. LactoSpore® Bacillus coagulans demonstrates a higher percentage of phagocytosis cells, suggesting its beneficial effect in enhancing immune system. LactoSpore® B. coagulans supports healthy immune system.