Research Capsule

Studies on Lonza’s wax-matrix extended-release niacin (vitamin B3), and Lorand Laboratories’ BiAloe

Lonza’s wax-matrix extended-release niacin (vitamin B3)

Vital Stats: Lonza’s wax-matrix extended-release niacin (vitamin B3) supports healthy cholesterol levels and reduces flushing, a common side effect of niacin supplements.

Study claim: Wax-matrix extended-release niacin demonstrates good tolerance, efficacy and extended-release kinetics in people with mild to moderate dyslipidemia – in contrast to inositol hexanicotinate (IHN), another extended-release niacin that is well tolerated but no better than placebo in lipid improvement and shows no evidence of bioavailability.

Published: Keenan, JM. Wax-matrix extended-release niacin vs inositol hexanicotinate: A comparison of wax-matrix, extended-release niacin to inositol hexanicotinate "no-flush" niacin in persons with mild to moderate dyslipidemia. J Clin Lipidol 2013 Jan;7(1):14-23.

Abstract: Nicotinic acid (NA), long used to treat dyslipidemia, has shown problems with undesirable side effects and safety issues. Wax-matrix, extended-release niacin (WMER) and inositol hexanicotinate (IHN) have both been formulated to increase patient tolerability. Several trials of WMER demonstrated good efficacy in improving dyslipidemia; however, there are few scientific data on the use of IHN. This study was designed to compare the efficacy and tolerability of WMER and IHN to each other and placebo to help clinicians make an informed choice of NA agents.

Methods: This was a 6-week blinded, placebo-controlled trial comparing 1,500 mg/d of WMER with 1,500 mg/d IHN. Subjects with mild-to-moderate dyslipidemia (low-density lipoprotein = 130-190/dL) were randomized, after a 4-week diet lead-in period, to three parallel study arms (40 subjects/arm). Diet, pill compliance, and side effects were monitored as well as lipid and blood chemistry profiles (baseline, 6 weeks). A dose-reduction protocol was included for subjects who did not tolerate the 1,500-mg dose of NA. A pharmacokinetic substudy was conducted on subjects from the WMER (n = 5) and IHN (n = 5) groups.

Results: WMER demonstrated significant improvements in total cholesterol = -11%, low-density lipoprotein = -18%, high-density lipoprotein = +12%, and non-high-density lipoprotein = -15% (P < .001), whereas IHN and placebo showed no significant improvement in lipids. All groups had good medication compliance and treatment tolerance with only one dropout in the WMER group as the result of flushing. Blood chemistries showed small (24%-27%) mean increases in hepatic transaminases; six subjects completed the study at reduced dosage protocol with good lipid results. Pharmacokinetics demonstrated an intermediate release and absorption rate for WMER over 6 hours and IHN showed no evidence of bioavailability.

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Lorand Laboratories’ BiAloe

Vital Stats: Lorand Laboratories’ BiAloe, an aloe poly-mannose multi-nutrient complex containing acetylated polymannose, stabilized rice bran, larch tree fiber, and larch tree soluble extract.

Study Claim: Supplementing with BiAloe over 12 months produced improvements in cognitive and immune function in 46 percent of study subjects with moderate-to-severe Alzheimer’s Disease (AD).

Published: Lewis, JE, et. al. The effect of an aloe polymannose multinutrient complex on cognitive and immune functioning in Alzheimer's disease. J Alzheimers Dis 2013;33(2):393-406.

Abstract: Alzheimer's disease (AD), a leading killer of Americans, imparts a significant toll on the quality of life of the patient and primary caregiver, and results in inordinate costs in an already overburdened medical system. Prior studies on cholinesterase inhibitors among AD patients have shown minimal amelioration of disease symptoms and/or restoration of lost cognitive functioning. The effect of improved nutrition, particularly with dietary supplements, on cognitive functioning may offer an alternative strategy compared to standard treatment.

The present pilot study investigated the effect of an aloe polymannose multinutrient complex (APMC) formula on cognitive and immune functioning over 12 months among adults diagnosed with AD. Subjects participated in an open-label trial and consumed 4 teaspoons per day of the APMC. The ADAS-cog, MMSE, ADCS-ADL, and SIB were administered at baseline and 3, 6, 9, and 12 months follow-up. Cytokines and lymphocyte and monocyte subsets were assessed at baseline and 12 months. The mean ADAS-cog cognition score significantly improved at 9 and 12 months from baseline, and 46% of the sample showed clinically significant improvement (≥4-point change) from baseline to 12 months. Participants showed significant decreases in tumor necrosis factor-alpha, vascular endothelial growth factor, and interleukins-2 and-4. Signifncant decreases were observed in CD90+, CD95+CD3+, CD95+CD34+, CD95+CD90+, CD14+CD34+, CD14+CD90+, and CD14+CD95+, whereas CD14+ significantly increased. Participants tolerated the APMC supplement with few, temporary adverse reactions. Our results showed improvements in both clinical and physiological outcomes for a disease that otherwise has no standard ameliorative remedy.

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