Carol A Morris

Tear Glucose Dynamics in Diabetes Mellitus

This study compares tear glucose dynamic differences between 121 diabetic and nondiabetic subjects after the administration of a carbohydrate load. A quantitative chromatographic analysis of tear glucose was used and the values correlated to blood glucose values. Diabetic and nondiabetic tear glucose mean values were 0.35 ± 0.04 mmol/L and 0.16 ± 0.03 mmol/L, respectively. Significant differences were observed among the subject groups in both the tear and capillary blood glucose values. A correlation between tear glucose and capillary blood glucose was observed. The concentration of glucose in the tear fluid changes proportionately with respect to capillary blood glucose after a carbohydrate challenge. Although it is possible to determine the diabetic status of a subject using tear glucose values alone, in the clinical setting this may not prove to be practical due to technical limitations.

Bovine lactoferrin supplementation supports immune and antioxidant status in healthy human males

Dietary supplements of bovine lactoferrin are purported in consumer literature to enhance and support the immune system response through their antioxidant, antibacterial, and antiviral properties. Our aim was to investigate more fully the potential immune modulating properties and antioxidant activity of an oral supplementation of bovine lactoferrin in humans. Using an intraindividual repeated measure design, 8 healthy males aged 30 to 55 years, self-administered daily for 21 days, one capsule of placebo for 7 days, followed by 100 mg of lactoferrin for 7 days, followed by 200 mg of lactoferrin for 7 days. Peripheral blood lymphocyte subset counts, T-cell activation, natural killer (NK) cell cytotoxicity, serum cytokine levels (tumor necrosis factor [TNF]-alpha, interferon [IFN]-gamma, interleukin [IL]-2, IL-4, IL-6, and IL-10), and serum hydrophilic, lipophilic, and total antioxidant capacity were repeatedly measured before and after each progressive supplementation. Statistically significant increases were found between presupplementation levels and levels after 200 mg of supplementation in total T-cell activation (as measure by CD3(+)) (P < .001), helper T-cell activation (as measure by CD4(+)) (P < .001), cytotoxic T-cell activation (as measured by CD8(+)) (P < .001), and hydrophilic antioxidant capacity (P < .05). No significant changes were seen in the other parameters measured. These results support the proposal that oral supplements of bovine lactoferrin may be a useful adjunct toward modulation of immune activity, in particular T-cell activation and antioxidant status.

A combined phase I and II open label study on the effects of a seaweed extract nutrient complex on osteoarthritis

Background: Isolated fucoidans from brown marine algae have been shown to have a range of anti-inflammatory effects. Purpose: This present study tested a Maritech® extract formulation, containing a blend of extracts from three different species of brown algae, plus nutrients in an open label combined phase I and II pilot scale study to determine both acute safety and efficacy in osteoarthritis of the knee. Patients and methods: Participants (n = 12, five females [mean age, 62 ± 11.06 years] and seven males [mean age, 57.14 ± 9.20 years]) with a confirmed diagnosis of osteoarthritis of the knee were randomized to either 100 mg (n = 5) or 1000 mg (n = 7) of a Maritech® extract formulation per day. The formulation contained Maritech® seaweed extract containing Fucus vesiculosis (85% w/w), Macrocystis pyrifera (10% w/w) and Laminaria japonica (5% w/w) plus vitamin B6, zinc and manganese. Primary outcome was the average comprehensive arthritis test (COAT) score which is comprised of four sub-scales: pain, stiffness, difficulty with physical activity and overall symptom severity measured weekly. Safety measures included full blood count, serum lipids, liver function tests, urea, creatinine and electrolytes determined at baseline and week 12. All adverse events were recorded. Results: Eleven participants completed 12 weeks and one completed 10 weeks of the study. Using a multilevel linear model, the average COAT score was reduced by 18% for the 100 mg treatment and 52% for the 1000 mg dose at the end of the study. There was a clear dose response effect seen between the two treatments (P ≤ 0.0005) on the average COAT score and each of the four COAT subscales (pain, stiffness, difficulty with physical activity and overall symptom severity) (P ≤ 0.05). The preparation was well tolerated and the few adverse events were unlikely to be related to the study medication. There were no changes in blood parameters measured over the course of the study with the exception of an increase in serum albumin which was not clinically significant. Conclusion: The seaweed extract nutrient complex when taken orally over twelve weeks decreased the symptoms of osteoarthritis in a dose-dependent manner. It was demonstrated to be safe to use over the study period at the doses tested. The efficacy of the preparation now needs to be demonstrated in a phase III randomized controlled trial (RCT). Australian and New Zealand Clinical Trials Register: ACTRN12607000229471.

A combined Phase I and II open-label study on the immunomodulatory effects of seaweed extract nutrient complex

Background: Isolated fucoidans from brown marine algae have been shown to have a range of immune-modulating effects. This exploratory study aimed to determine whether a seaweed nutrient complex containing a blend of extracts from three different species of brown algae plus nutrients is safe to administer and has biological potential as an immune modulator. The study was undertaken as an open-label combined Phase I and II study. Methods: Participants (n = 10) were randomized to receive the study medication at either a 100 mg (n = 5) or 1000 mg (n = 5) dose over 4 weeks. The primary outcome measurement was in vivo changes in lymphocyte subsets. The secondary outcome measures were ex vivo changes in T-lymphocyte (CD4 and CD8) activation, phagocytosis of granulocytes and monocytes, T helper 1/T helper 2 cytokines, and serum oxygen radical absorbance capacity. Results: The preparation was found to be safe over the 4 weeks at both doses tested. There were no clinically relevant changes to blood measurements of hemopoietic, hepatic, or renal function. Immunomodulatory measurements showed no dose response between the two doses. The combined results from the two doses demonstrated a significant increase in cytotoxic T cell numbers and phagocytic capacity in monocytes, and a significant decrease in levels of the inflammatory cytokine interleukin 6. A separate analysis of the 100 mg dose (n = 5) alone showed a significant linear component over time (P < 0.05) for phagocytosis by both granulocytes and monocytes. Conclusion: The seaweed nutrient complex was safe to use when taken orally over 4 weeks. The preparation was demonstrated to have potential as an immune modulator, and this bioactivity deserves further exploration.

Improvement of penile erection, sperm count and seminal fructose levels in vivo and nitric oxide release in vitro by ayurvedic herbs

In the present study, the effect of four Vajikaran Rasayana herbs on penile erection, sperm count, seminal fructose content in vivo and nitric oxide (NO) release in vitro was assessed. Lyophilised aqueous extracts of Asparagus racemosus Willd. (AR), Chlorophytum borivilianum Sant. F. (CB), Curculigo orchioides Gaertn. (CO), and Dactylorhiza hatagirea (D. Don) Soo (DH) were orally administered at 100 mg/kg body weight to Wistar strain male albino rats. Penile erection index and sperm count were determined by visual observation; the seminal fructose concentration was measured spectrophotometrically using resorcinol reagent; and NO release was assessed in a mouse macrophage cell line (RAW264) spectrophotometrically using a commercial Griess reagent kit. Penile erection index, sperm count, seminal fructose concentration and in vitro NO release were the parameters measured. A significant effect on the sperm count, seminal fructose content and penile erection index was observed upon treatment with the extracts. The effect of extracts on inducible NO release in vitro directly correlated with the enhanced erectile function in vivo. The aphrodisiac claims attributed to the four Vajikaran Rasayana herbs were tested and a distinctive effect of all extracts tested was observed, with C. borivilianum showing a highly significant response for all parameters measured in vivo and in vitro. The present study also provides a good correlation between the in vivo improvement of penile erection and in vitro NO releasing activity of the extracts. Increase in seminal fructose levels and sperm count further validates the role of these herbs in improving reproductive function.

Immunomodulatory Polysaccharide from Chlorophytum borivilianum Roots

Chlorophytum borivilianum Santapau & Fernandes (Liliaceae) is an ayurvedic Rasayana herb with immunostimulating properties. The polysaccharide fraction (CBP) derived from hot water extraction of C. borivilianum (CB), comprising of ∼31% inulin-type fructans and ∼25% acetylated mannans (of hot water-soluble extract), was evaluated for its effect on natural killer (NK) cell activity (in vitro). Human peripheral blood mononuclear cells (PBMCs), isolated from whole blood on a Ficoll-Hypaque density gradient, were tested in the presence or absence of varying concentrations of each C. borivilianum fraction for modulation of NK cell cytotoxic activity toward K562 cells. Preliminary cytotoxicity evaluation against P388 cells was performed to establish non-cytotoxic concentrations of the different fractions. Testing showed the observed significant stimulation of NK cell activity to be due to the CBP of C. borivilianum. Furthermore, in vivo evaluation carried out on Wistar strain albino rats for humoral response to sheep red blood cells (SRBCs) and immunoglobulin-level determination using enzyme-linked immunosorbent assay (ELISA), exhibited an effectiveness of C. borivilianum aqueous extract in improving immune function. Present results provide useful information for understanding the role of CBP in modulating immune function.

A forced titration study of the antioxidant and immunomodulatory effects of Ambrotose AO supplement

BackgroundOxidative stress plays a role in acute and chronic inflammatory disease and antioxidant supplementation has demonstrated beneficial effects in the treatment of these conditions. This study was designed to determine the optimal dose of an antioxidant supplement in healthy volunteers to inform a Phase 3 clinical trial.MethodsThe study was designed as a combined Phase 1 and 2 open label, forced titration dose response study in healthy volunteers (n = 21) to determine both acute safety and efficacy. Participants received a dietary supplement in a forced titration over five weeks commencing with a no treatment baseline through 1, 2, 4 and 8 capsules. The primary outcome measurement was ex vivo changes in serum oxygen radical absorbance capacity (ORAC). The secondary outcome measures were undertaken as an exploratory investigation of immune function.ResultsA significant increase in antioxidant activity (serum ORAC) was observed between baseline (no capsules) and the highest dose of 8 capsules per day (p = 0.040) representing a change of 36.6%. A quadratic function for dose levels was fitted in order to estimate a dose response curve for estimating the optimal dose. The quadratic component of the curve was significant (p = 0.047), with predicted serum ORAC scores increasing from the zero dose to a maximum at a predicted dose of 4.7 capsules per day and decreasing for higher doses. Among the secondary outcome measures, a significant dose effect was observed on phagocytosis of granulocytes, and a significant increase was also observed on Cox 2 expression.ConclusionThis study suggests that Ambrotose AO® capsules appear to be safe and most effective at a dosage of 4 capsules/day. It is important that this study is not over interpreted; it aimed to find an optimal dose to assess the dietary supplement using a more rigorous clinical trial design. The study achieved this aim and demonstrated that the dietary supplement has the potential to increase antioxidant activity. The most significant limitation of this study was that it was open label Phase 1/Phase 2 trial and is subject to potential bias that is reduced with the use of randomization and blinding. To confirm the benefits of this dietary supplement these effects now need to be demonstrated in a Phase 3 randomised controlled trial (RCT).Trial RegistrationAustralian and New Zealand Clinical Trials Register: ACTRN12605000258651

Combined Neem oil 6% w/w and eucalyptus oil 16% w/w lotion for treating head lice: In vitro and in vivo efficacy studies

To test a combined neem oil 6% w/w and eucalyptus oil 16% w/w lotion for the whole‐of‐life cycle treatment of human head lice (Pediculus humanus var. capitis) infestation.

Lactoferrin in Immune Function, Cancer and Disease Resistance

Lactoferrin (Lf) is a glycoprotein found in milk and other body fluids. Supplements of Lf are isolated from cow’s milk. Lf possesses immune-modulating, antioxidant and anti-inflammatory properties which together support its anticancer activity. Lf also possesses strong antimicrobial activity against a diverse range of bacteria, fungi, parasites and viruses.