Scientific Studies

A clinical trial describes how supplementation with a herbal and vitamin formulation for 12 weeks may improve the symptoms of hyperglycemia.

The nutraceutical, in the form used in the study, contained a combination of three medicinal herb extracts – including bitter melon, fenugreek, cinnamon, along with the micronutrients zinc, biotin, chromium, cholecalciferol and alpha-lipoic acid.

In this randomized, double-blind, placebo-controlled clinical trial, researchers at Mahidol University evaluated the efficacy of the product in a total of 110 recruited adults (20-70 yrs), who were allocated to receive either the test nutraceutical or a placebo (microcrystalline cellulose) without the active ingredients for 12 weeks.

The investigators evaluated the effects of the formula on fasting blood glucose (FBG), hemoglobin A1c (HbA1C), blood lipid and cholesterol levels, the homeostatic model assessment of insulin resistance (HOMA-IR) scoring system, oxidative stress and inflammation biomarkers at weeks 0, 6 and 12 of intervention.

At the end of the study, the outcome analysis revealed that subjects who had taken the test formula showed a significant decrease in FBG and HOMA-IR (P<0.001) at 6-weeks and a significant decrease in HbA1C (P<0.001) by week 12.

In addition, low density lipoprotein cholesterol (LDL-C) levels, and oxidative stress markers, oxidized LDL-C and MDA, had also declined, in comparison to the placebo group. Although not statistically significant, there was also a trend towards a decline in blood lipids and the inflammatory marker, hsCRP (P = 0.072 and P = 0.062).

There were no significant differences between the two groups in relation to adverse effects, however, 6% of the nutraceutical group experienced an improvement in bowel movements, which may be an effect of the actions of cinnamon and fenugreek.

In summary, the research outcomes suggest that supplementing with the test formula may alleviate biomarkers of hyperglycemia and may contribute to a progressive improvement in cardiovascular health status and general wellbeing.

Reference: Bumrungpert A, et al. Natural Product Communications. April 2020. Volume 15(4): 1–11.

Financial sponsor of study: Max Biocare Pty Ltd.

Full text available at: https://journals.sagepub.com/doi/full/10.1177/1934578X20918687

A clinical trial, published in the Journal of Dietary Supplements in 2020, describes how supplementation with a multi-herbal formula for 12 weeks may improve the symptoms of menopause.

The nutraceutical is a botanical product comprising of four medicinal herb extracts – soy isoflavones, black cohosh, chaste-berry and evening primrose oil.

In this randomized, double-blind, placebo-controlled clinical trial, researchers in Dhurakij Pundit University evaluated the efficacy of the product in post-menopausal women.

A total of 110 Thai women (45-60 yrs) were recruited, including those who had stopped their menstrual period for at least 12 months and reported menstrual symptoms.

The group was split into two, with the test group given one capsule of the product, and the other given a soybean capsule as a placebo control.

Symptoms were measured using the clinically validated 11-point menopause rating scale (MRS) questionnaire, and blood samples were taken to determine safety and hormone status.

The outcomes showed a significant decrease in hot flushes and sweating (p<0.0001), irritability symptoms (p<0.0003), depressed mood (p<0.0004) and sleep problems (p<0.0005) in the test group, compared to the placebo.

The women reported no significant differences in heart discomfort, joint/muscular discomfort, or physical/mental exhaustion. Vaginal dryness was decreased in severity at 12 weeks, compared to baseline (p=0.05).

Regarding cardiovascular health, women within the test group showed reductions from the start of the trial in their low-density lipoprotein cholesterol (LDL-C) after 6 weeks (p<0.024) and 12 weeks (p<0.0015), as well as a decrease in their blood lipids after 6 weeks and 12 weeks, with no change in total cholesterol.

Additionally, the treatment group showed a marked reduction in their blood levels of high sensitivity C-reactive protein (hsCRP) (p<0.0002), compared to the placebo, which is a globally used marker of inflammation status.

The outcomes suggest that supplementing with the nutraceutical may improve menopause symptoms, cardiovascular health status and general wellbeing in post-menopausal women, in support of previous evidence for the individual herbal ingredients.

Reference: Rattanatantikul et al. Journal of Dietary Supplements 2020, 19(2), 168-183

Full text available at: https://www.tandfonline.com/doi/full/10.1080/19390211.2020.1853648

Financial sponsor of study: Max Biocare Pty Ltd.

The present study looked at one of our botanical products comprising four medicinal herb extracts – soy isoflavones, black cohosh, chasteberry and evening primrose oil.

In this second part of a randomized, double-blind, placebo-controlled clinical trial, published in the Journal of Cosmetic Dermatology in 2021, researchers in Dhurakij Pundit University evaluated the effects of the nutraceutical skin health and aging indicators in post-menopausal women.

A total of 110 Thai women (45-60 yrs) were recruited, including those who had stopped their menstrual period for at least 12 months and reported menstrual symptoms, and who showed type II and III fine lines and wrinkles.

Participants were randomly allocated to receive either a test product or a soybean extract (as a placebo control) capsule for 12 weeks while maintaining their usual diet and lifestyle.

Dermatologists measured a range of skin parameters at baseline, weeks 6 and 12, including wrinkles, texture, moisture level, and melanin levels in facial skin areas on the sides of both eyes.

Blood samples were also taken to determine the level of glutathione (GSH) as an indicator of antioxidant production, and malondialdehyde (MDA), a marker of lipid-based oxidative stress.

After 6 weeks, test formula users showed significant improvements in skin roughness compared to placebo. After 12 weeks, the test group also showed significant improvements in skin elasticity, roughness, smoothness, scaliness and wrinkle density.

Surprisingly, after 12 weeks, MDA levels in the blood of the test formula users were significantly decreased, while the levels of GSH were elevated, indicating an internal improvement in oxidative stress status.

There were no changes in trans-epithelial water loss (TEWL), melanin, skin gloss level or hydration levels between the two groups.

Some of the ways that the ingredients in the test formula may have induced these effects are through a combination of estrogen receptor (ER) binding effects of soy isoflavones, the barrier promoting effects of evening primrose oil fatty acids, and the antioxidant effects of chaste-berry and black cohosh polyphenols.

In summary, these results suggest that the test formula has a beneficial effect externally on aging skin while acting internally on the underlying mechanisms of oxidative stress, amongst others, that drive the aging process. This is more pronounced in post-menopausal women who no longer produce estrogen, an important regulator of skin turnover and integrity.

Reference: Tumsutti et al. J Cosmet Dermatol. 2021 Jul 14 (ahead of print)

Full text available at: https://onlinelibrary.wiley.com/doi/epdf/10.1111/jocd.14345

Financial sponsor of study: Max Biocare Pty Ltd.

This clinical trial was aimed at evaluating the efficacy of Belmarama™ Rejuvenating Capsules, a unique encapsulated cosmetic serum, on facial skin characteristics.

The capsule design was chosen because it represents a unique, highly stable form of application that is resistant to degradation of ingredients with antioxidant properties, particularly in countries with hotter climates.

The trial was conducted by researcher and clinicians at the College of Integrative Medicine, Dhurakij Pundit University, and Siriraj Hospital, Mahidol University in Bangkok, Thailand, and the results were later published in the Journal of Cosmetic Dermatology in 2020.

A total of 50 Thai women (aged 30-65 yrs) were recruited to participate in the trial, for which they were allocated one capsule to be applied on one side of the face for 8 months, The other side of their face represented the untreated (control) side, and subjects maintaining their normally daily facial skin routine for both sides.

Dermatologists measured a range of skin parameters at baseline, weeks 4 and 8, including elasticity, elasticity, radiance, moisture, water evaporation, color and surface texture.

By 4 weeks, a significant difference was observed in skin gloss value, smoothness, scaliness and wrinkle density. By the 8-week mark, these differences were maintained, along with improvements in elasticity, melanin index (lighter pigment). There were no differences in moisture level, water loss or skin lifting around the eyes.

In summary, the present evaluation revealed improvements in skin integrity and pigmentation that indicated an anti-aging effect on Asian skin types. These effects are possibly related to the anti-oxidant actions of the serum ingredients.

Reference: Rattanawiwatpong et al. J Cosmet Dermatol. 2020 Mar;19(3):671-676

Full text available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7027822/pdf/JOCD-19-671.pdf

Financial sponsor of study: Max Biocare Pty Ltd.

A clinical pilot study describes how supplementation with a naturally derived formula may improve the symptoms of gout.

The nutraceutical, in the form used in the study, contained a combination of medicinal herb extracts – including Tart cherry (Prunus cerasus), Devil’s Claw (Harpagophytum procumbens), Celery seed (Apium graveolens), along with the micronutrients, potassium citrate, vitamin C and folic acid.

In this single arm study, researchers at the National Hospital of Traditional Medicine, Hanoi, Vietnam,  evaluated the efficacy, safety and tolerability of the product in a total of 35 recruited adults (mean age 54 yrs) diagnosed with chronic gout. The subjects were allocated 4 tablets of the test product daily for a period of 45 days.

The investigators evaluated the effects of the formula on self-rated pain severity, swelling, redness and warmth in joints affected by gout. These include finger joints, ankle, knee or elbow, as well as their heel. Ratings were recorded on day 0 (baseline), 15, 30 and 45 of the intervention.

Clinical evaluations also included monitoring for blood indicators of liver or kidney toxicity, inflammation and changes in their general vital signs, including blood pressure.

Regarding efficacy, as soon as 15 days after product use, subjects observed an almost complete reduction in global joint pain, which was sustained until the end of the trial. By day 30, subjects also reported a complete reduction in joint swelling, which was also sustained until completion.

The average blood uric acid level had also declined significantly by 5% (p=0.024) by the end of the trial, compared to baseline.

In relation to safety, there were no significant differences in serum markers of liver function, blood cell counts or vital signs throughout the treatment.

In summary, the outcomes of the study suggest that the herbal/micronutrient formula can result in a measurable improvement in symptoms of gout as an alternative to standard medications. This is encouraging, given the subjects did not use other medications or supplements during the study.

Reference: Vu et al. J Complement Integr Med. 2020 May 19;18(1):113-121.

Full text available at: https://www.degruyter.com/document/doi/10.1515/jcim-2019-0074/html

Financial sponsor of study: Max Biocare Pty Ltd.

A clinical trial published in the journal, Nutrients, in 2022, describes how supplementation with an Iron bisglycinate multi performed comparably to standard management for women with iron deficiency.

The iron supplement is a multi-nutrient soft-gel formula comprising of iron in the form of iron bisglycinate (equivalent to 24mg of elemental iron), folinic acid, and vitamins B1, B2, B6, B9 and B12.

In this randomized, double-blind, placebo-controlled clinical trial, researchers at the Antenatal Care Clinical of the Health Promotion Hospital in Ratchaburi, Thailand, evaluated the efficacy of the product in post-menopausal women.

A total of 120 women at 12-16 weeks of pregnancy were recruited for the trial, and randomly allocated to the test group (Iron Up®, 24mg iron, with folinic acid) or the control group (66mg iron) with identical levels of the other ingredients in either group.

Blood samples were taken at baseline, 3- and 6-months, for the measurement of iron absorption, hemoglobin, immature and mature red blood cell counts, ferrtin and high sensitivity C-reactive protein (hsCRP, a marker of inflammation). Additionally, the recruited subjects were surveyed about their quality of life, adverse effects and newborn weight.

Results showed that both test and control groups experienced an increase in serum iron, however the Iron Up® group showed a more marked increase per timepoint. Similarly, both groups showed increases in serum hemoglobin, red cell counts and ferritin, but the test group again showed a more pronounced improvement. Furthermore, instantaneous iron absorption was higher for the test group compared to the control group.

Subjects who took the test nutraceutical reported fewer instances of metallic taste, bloating, abdominal pain, nausea or constipation, and reported an improvement in their quality of life at 3 and 6 months, despite quality of life showing a decrease in all groups as pregnancy progressed. In terms of birth outcome, children born to women in the test group had a small but statistically significant birthweight compared to control babies.

In summary, the results of this study suggest that supplementation with the test formula improves short-term iron absorption and progressive iron levels across pregnancy, along with improved hematological outcomes, quality of life and newborn weight, with fewer side effects, in women with iron deficiency. This is despite the test formula having 66% lower iron than the control and highlights the importance of considering the type of iron used, rather than simply the dosage given.

Reference: Bumrungpert et al. Nutrients. 2022 Jan 20;14(3):452

Financial sponsor of study: Max Biocare Pty Ltd.

Full text available at: https://www.mdpi.com/2072-6643/14/3/452