Intake of Commercially Produced Fermented Soy Powder Q CAN PLUS® Favorably Changes Cholesterol and Isoflavone Intake in Individuals at High Risk of Cardiovascular Disease

Objectives Q CAN PLUS® is a fermented soy powder currently marketed in the US as a food product. We conducted a feeding trial to examine the effects of Q CAN PLUS® on the nutrient composition of the habitual diets of individuals at high risk of cardiovascular diseases. We hypothesized that the nutrient profile, particularly nutrients associated with CVD risk, differs among individuals in the Q CAN PLUS® phase compared to the placebo phase. Methods Study design was a randomized, controlled crossover intervention with twenty-four free living adults (29–75 years old; 80% female; 8% normal BMI, 45% overweight, 47% obese) at high risk of cardiovascular diseases. Subjects were randomized to receive either Q CAN PLUS® (fermented soy) powder or placebo powder for twelve weeks and switched over to the placebo treatment after two weeks of wash out period. Two 24-hour dietary recalls were collected during each phase which included one weekday and one weekend dietary recall. The nutrient consumption per day (mean ± SD) were based on a synthetic week by using the following formula: ((weekday * 5) +(weekday * 2))/7. Results On average, intake of cholesterol (211 ± 169 mg) was 13% lower (P = 0.05) in the Q CAN PLUS® phase compared to placebo (243 ± 179 mg). Total soy isoflavones (444 ± 210 mg) was 12 times higher (P < 0.0001) during Q CAN PLUS® phase than the placebo phase (33 ± 93 mg). Dietary total carbohydrate, total protein, vegetable protein, animal protein during Q CAN PLUS® phase were not statistically different from placebo phase. Conclusions The differences in the intake of cholesterol and total soy isoflavones may have implications on risk of cardiovascular diseases. Funding Sources BESO Biological Research Inc Diamond Bar, CA, USA.

Lathosterol in plasma measures cholesterol synthesis and identifies the efficiency of dietary phytosterols in reducing the plasma cholesterol concentration

Background Because the plasma campesterol/cholesterol ratio does not differ between groups that absorb different amounts of cholesterol measured by the gold standard isotopic procedure we investigated whether the intestinal absorption of phytosterols (PS) depends on the body's cholesterol synthesis rate. Methods 38 volunteers (58 ± 12 years; low-density lipoprotein cholesterol (LDL-C) ≥ 130 mg/dL) were randomly assigned to consume 400 mL/day of soy milk or soy milk + PS (1.6 g/day) for 4 weeks in a double-blind, placebo-controlled, cross-over study. Blood samples were collected and markers of phytosterol (PS) absorption and non-cholesterol sterol synthesis precursors measured. Results PS treatment reduced plasma total cholesterol concentration (-5,5%, p < 0.001), LDL-C (-7.6%, p < 0.001), triglycerides (-13.6%, p < 0.0085), and apolipoprotein B (apo B) (-6.3%, p < 0.008), without changing high density lipoprotein cholesterol (HDL-C concentration). The lathosterol-to-cholesterol ratio in serum predicted the serum cholesterol response to PS feeding where high basal cholesterol synthesis was associated with lack of response of plasma cholesterol to PS in the diet. Cholesterol synthesis being elevated in the placebo phase in non-responders to dietary PS indicated they were resistant to further synthesis rise, whereas responders, because they have lower synthesis rate than non-responders in the placebo phase, are capable expanding synthesis under the effect of alimentary PS. Conclusions responders absorbed more PS than non-responders likely resulting from responders delivering less endogenous cholesterol than non-responders into the intestinal lumen that facilitates greater absorption of PS by the intestine.

Randomized, controlled crossover study of IVIg for demyelinating polyneuropathy and diabetes

ObjectiveTo determine whether IV immunoglobulin (IVIg) is more effective than placebo at reducing disability in patients with diabetes and demyelinating polyneuropathy features.MethodsThis is a double-blinded, single-center, randomized, controlled crossover trial of IVIg treatment vs placebo. The primary outcome measure was the mean change in Overall Neuropathy Limitation Scale (ONLS) scores during the IVIg phasecompared with the placebo phase. Secondary outcomes include changes in the Rasch-built Overall Disability Scale, Medical Research Council sum scores, grip strength, electrophysiologic measurements, quality of life, and adverse effects.ResultsTwenty-five subjects were recruited between March 2015 and April 2017. The mean change in ONLS scores was −0.2 points during the IVIg phase and 0.0 points during the placebo phase (p = 0.23). Secondary outcomes did not show significant differences between IVIg and placebo.ConclusionsIVIg did not reduce disability, improve strength, or quality of life in patients with demyelinating polyneuropathy features and diabetes after 3 months of treatment in comparison with placebo. Therefore, careful consideration of the primary diagnosis is required before immunomodulatory therapy.Classification of evidenceThis study provides Class I evidence that for patients with diabetes and demyelinating polyneuropathy features, IVIg did not significantly reduce disability.

Effect of Repeated Sodium Phosphate Loading on Cycling Time-Trial Performance and VO2peak

Research into supplementation with sodium phosphate has not investigated the effects of a repeated supplementation phase. Therefore, this study examined the potential additive effects of repeated sodium phosphate (SP) supplementation on cycling time-trial performance and peak oxygen uptake (VO2peak). Trained male cyclists (N = 9, M ± SD VO2peak = 65.2 ± 4.8 ml · kg−1 · min−1) completed baseline 1,000-kJ time-trial and VO2peak tests separated by 48 hr, then ingested either 50 mg · kg fat-free mass−1 · d−1 of tribasic SP or a combined glucose and NaCl placebo for 6 d before performing these tests again. A 14-d washout period separated the end of one loading phase and the start of the next, with 2 SP and 1 placebo phase completed in a counterbalanced order. Although time-trial performance (55.3–56.5 min) was shorter in SP1 and SP2 (~60–70 s), effect sizes and smallest-worthwhile-change values did not differ in comparison with baseline and placebo. However, mean power output was greater than placebo during time-trial performance at the 250-kJ and 500-kJ time points (p < .05) after the second SP phase. Furthermore, mean VO2peak values (p < .01) were greater after the SP1 (3.5–4.3%), with further improvements (p < .01) found in SP2 (7.1–7.7%), compared with baseline and placebo. In summary, repeated SP supplementation, ingested either 15 or 35 d after initial loading, can have an additive effect on VO2peak and possibly time-trial performance.

Cardiovascular Effects of Spinal Cord Stimulation in Hypertensive Patients

Background: Several animal and clinical studies have shown that thoracic spinal cord stimulation (SCS) may decrease mean arterial pressure (MAP). A previous study in normotensive participants demonstrated a small reduction in MAP during SCS at the T5-T6 spinal level. It has also been demonstrated that chronic SCS at the subthreshold stimulation level significantly improved angina attacks and 6 minute hall walk distance in drug refractory angina patients. Objectives: To determine if thoracic SCS at 2 different stimulation strengths would decrease blood pressure (BP) and heart rate (HR) during baseline conditions and during activation of the sympathetic system by the cold pressor test (CPT). Methods: Six hypertensive participants and 9 normotensive participants were evaluated. The SCS leads were implanted under sedation (midazolam and fentanyl) 3 days prior to the study. The SCS device was not implanted at the time of lead implantation; the exteriorized leads were connected to an external programmer at the time of the study. MAP was measured at the finger using beat-to-beat photoplethysmographic recordings at rest and during CPT with a Finometer (Model 1, Finapress Medical Systems, Amsterdam, The Netherlands). SCS at threshold (100%, SCS100) and subthreshold (80%, SCS80) intensities were randomly performed in the T5-T6 region of the spinal cord during normal conditions as well as during CPT. Each participant had 3 CPTs with the placebo (control, no SCS) CPT always performed first. CPT was performed by immersing the right hand into ice water for 90 seconds. Thirty seconds of beat-to-beat data prior to starting each CPT (baseline) was analyzed. During the 90 second CPT, the median values of the last 30 seconds of data were used for analysis. Heart rate variability (HRV) during baseline and SCS was computed using Kubios HRV Version 2.0 software (University of Kuopio, Kuopio, Finland). Since the median values of HR, MAP and their changes did not follow a normal distribution, groups were compared with a non-parametric Friedman’s or Wilcoxon’s signed rank test. The HRV data were normally distributed and a repeated measures analysis of variance (ANOVA) was used. Results: SCS did not significantly alter MAP or HR at baseline nor did it appear to blunt changes in MAP or HR in response to CPT. In the normotensive group, MAP was significantly elevated by a median value of 16 mmHg (P<0.001) during the placebo phase, and by 18 and 10.5 mmHg during the SCS80 and SCS100 phases, respectively. In the hypertensive group, an enhanced response to the CPT was observed. In these participants, the MAP was significantly elevated by a median value of 26.8 mmHg (P<0.001) during the placebo phase, and by 20 and 17 mmHg during the SCS80 and SCS100 phases, respectively. There was a non-significant trend for the CPT-induced increase in BP to be attenuated during SCS80. HRV tended to decrease in both the time and frequency domain in hypertensive participants, although this decrease was not statistically significant. Limitations: This was a pilot study including a limited number of participants Conclusions: Acute SCS at the T5-T6 region did not significantly alter MAP or HR compared to baseline (no SCS) in participants without sedation, supporting our previous findings in sedated patients. Hypertensive participants had a heightened response to transient cold stress, consistent with the literature. The observation of the tendency for a reduction in HRV in both the time and frequency domain in hypertensive participants is also consistent with the literature. In contrast to acute SCS, the hemodynamic effects of chronic SCS should be explored in the future. Key words: Spinal cord stimulation, hemodynamics, cold pressor test, heart rate variability, hypertension

Medium-dose riboflavin as a prophylactic agent in children with migraine: A preliminary placebo-controlled, randomised, double-blind, cross-over trial

Background: Riboflavin seems to have a promising effect on migraine in adults. The present study examines whether riboflavin has a prophylactic effect on migraine in children. Objective: To investigate whether riboflavin in a dosage of 50 mg/day has a prophylactic effect on migraine attacks in young children. Subjects and methods: This randomised, placebo-controlled, double-blind, cross-over trial included 42 children (aged 6–13 years) with migraine of whom 14 children were also suffering from tension-type headache. Following a 4-week baseline period, all children received placebo for 16 weeks then riboflavin for 16 weeks (or vice versa) with a washout period of 4 weeks in between. The primary outcome measure was reduction in mean frequency of migraine attacks and tension-type headache in the last 4 weeks at the end of the riboflavin and placebo phase, compared with the preceding baseline or wash-out period. Secondary outcome measures were mean severity and mean duration of migraine and tension-type headaches in the last 4 weeks at the end of the riboflavin and placebo phase, compared with the preceding baseline or wash-out period. Results: No significant difference in the reduction of mean frequency of migraine attacks in the last month of treatment was found between placebo and riboflavin ( P = 0.44). However, a significant difference in reduction of mean frequency of headaches with a tension-type phenotype was found in favour of the riboflavin treatment ( P = 0.04). Conclusions: In this group of children with migraine, there is no evidence that 50 mg riboflavin has a prophylactic effect on migraine attacks. We found some evidence that 50 mg riboflavin may have a prophylactic effect on interval headaches that may correspond to mild migraine attacks or tension-type headache attacks in children with migraine.