scholarly journals Comparing the serum TAG response to high-dose supplementation of either DHA or EPA among individuals with increased cardiovascular risk: the ComparED study

2019 ◽  
Vol 121 (11) ◽  
pp. 1223-1234 ◽  
Author(s):  
Janie Allaire ◽  
Cécile Vors ◽  
William S. Harris ◽  
Kristina Harris Jackson ◽  
André Tchernof ◽  
...  
Keyword(s):  
Individual Variation ◽  
Hdl Cholesterol ◽  
High Dose ◽  
Double Blind ◽  
Men And Women ◽  
Predictors Of Response ◽  
Normal Mean ◽  
Secondary Analyses ◽  
The Mean ◽  
Long Chain

AbstractStudies have shown that the reduction in serum TAG concentrations with long-chain n-3 fatty acid supplementation is highly variable among individuals. The objectives of the present study were to compare the proportions of individuals whose TAG concentrations lowered after high-dose DHA and EPA, and to identify the predictors of response to both modalities. In a double-blind, controlled, crossover study, 154 men and women were randomised to three supplemented phases of 10 weeks each: (1) 2·7 g/d of DHA, (2) 2·7 g/d of EPA and (3) 3 g/d of maize oil, separated by 9-week washouts. As secondary analyses, the mean intra-individual variation in TAG was calculated using the standard deviation from the mean of four off-treatment samples. The response remained within the intra-individual variation (±0·25 mmol/l) in 47 and 57 % of participants after DHA and EPA, respectively. Although there was a greater proportion of participants with a reduction >0·25 mmol/l after DHA than after EPA (45 υ. 32 %; P < 0·001), the mean TAG reduction was comparable between groups (–0·59 (sem 0·04) υ. –0·57 (sem 0·05) mmol/l). Participants with a reduction >0·25 mmol/l after both DHA and EPA had higher non-HDL-cholesterol, TAG and insulin concentrations compared with other responders at baseline (all P < 0·05). In conclusion, supplementation with 2·7 g/d DHA or EPA had no meaningful effect on TAG concentrations in a large proportion of individuals with normal mean TAG concentrations at baseline. Although DHA lowered TAG in a greater proportion of individuals compared with EPA, the magnitude of TAG lowering among them was similar.

scholarly journals High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

2003 ◽  
Vol 47 (3) ◽  
pp. 1072-1080 ◽  
Author(s):  
Spotswood L. Spruance ◽  
Terry M. Jones ◽  
Mark M. Blatter ◽  
Mauricio Vargas-Cortes ◽  
Judy Barber ◽  
...  
Keyword(s):  
Day Treatment ◽  
High Dose ◽  
Herpes Labialis ◽  
Lesion Development ◽  
Multicenter Studies ◽  
Double Blind ◽  
Cold Sore ◽  
Treatment Groups ◽  
The Mean ◽  
Cold Sores

ABSTRACT Oral valacyclovir is better absorbed than oral acyclovir, increasing acyclovir bioavailability three- to fivefold. This provides the opportunity to explore whether high systemic acyclovir concentrations are effective in the treatment of cold sores (herpes labialis). Two randomized, double-blind, placebo-controlled studies were conducted. Subjects were provided with 2 g of valacyclovir twice daily for 1 day (1-day treatment), 2 g of valacyclovir twice daily for 1 day and then 1 g of valacyclovir twice daily for 1 day (2-day treatment), or a matching placebo and instructed to initiate treatment upon the first symptoms of a cold sore. In study 1, the median duration of the episode (primary endpoint) was reduced by 1.0 day (P = 0.001) with 1-day treatment and 0.5 days (P = 0.009) with 2-day treatment compared to placebo. Similarly, the mean duration of the episode was statistically significantly reduced by 1.1 days with 1-day treatment and 0.7 days with 2-day treatment compared to placebo. The proportion of subjects in whom cold sore lesion development was prevented and/or blocked was increased by 6.4% (P = 0.096) with 1-day treatment and 8.5% (P = 0.061) with 2-day treatment compared to placebo. The time to lesion healing and time to cessation of pain and/or discomfort were statistically significantly reduced with valacyclovir compared to placebo. In study 2, results similar to those in study 1 were obtained. AEs were similar across treatment groups. These studies provide evidence supporting a simple, 1-day valacyclovir treatment regimen for cold sores that is safe and effective. The 1-day valacyclovir regimen offers patients a unique and convenient dosing alternative compared to available topical therapies.

Antiemetic effect of oral versus intravenous metoclopramide in patients receiving cisplatin: a randomized, double-blind trial.

1986 ◽  
Vol 4 (1) ◽  
pp. 98-103 ◽  
Author(s):  
L B Anthony ◽  
M G Krozely ◽  
N J Woodward ◽  
J D Hainsworth ◽  
K R Hande ◽  
...  
Keyword(s):  
High Performance ◽  
Serum Levels ◽  
Autonomic Arousal ◽  
High Dose ◽  
Tumor Type ◽  
Double Blind ◽  
Antiemetic Effect ◽  
Dose Oral ◽  
The Mean ◽  
To Receive

In a study of the antiemetic effectiveness of high-dose oral metoclopramide, 66 previously untreated patients receiving 60 mg/m2 cisplatin were entered into a double-blind randomized trial. Patients were stratified according to age and tumor type, then randomized to receive either oral or intravenous (IV) high-dose metoclopramide. Patients were evaluated for antiemetic protection, toxicity, affect (anxiety, hostility, and depression), and autonomic arousal (pulse rate and blood pressure) at three-hour intervals on the day of their chemotherapy. Metoclopramide serum levels were measured by high-performance liquid chromatography. Results indicated no significant differences between the oral and IV groups on any measurement of antiemetic protection, affect, or autonomic arousal. There were also no significant differences in side effects except for frequency of stools; patients who received oral metoclopramide had significantly more stools than patients who received IV metoclopramide. The mean (+/- SD) serum metoclopramide level at four hours achieved orally was 1,171 +/- 660 ng/mL; the mean (+/- SD) level achieved IV was 1,030 +/- 392 ng/mL (P = .498). We conclude that high-dose oral and IV regimens of metoclopramide as administered in this study have equivalent antiemetic efficacy in previously untreated patients receiving 60 mg/m2 cisplatin.

Aspirin, Dipyridamole and Platelet Survival in Patients with Diabetes Mellitus

1982 ◽  
Vol 63 (2) ◽  
pp. 205-209 ◽  
Author(s):  
Hilary Tindall ◽  
R. Colin Paton ◽  
George P. McNicol
Keyword(s):  
Diabetic Patients ◽  
High Dose ◽  
Double Blind ◽  
Regeneration Time ◽  
Dose Aspirin ◽  
Platelet Survival ◽  
Group I ◽  
The Mean ◽  
Group Ii ◽  
High Dose Aspirin

1. Platelet survival in 27 insulin-dependent diabetic patients with severe retinopathy was studied in a double-blind cross-over trial using placebo, aspirin (990 mg/day) and a combination of dipyridamole (225 mg/day) with aspirin at two dosage levels (330 mg and 990 mg/day). 2. Twenty patients (group I) had 51Cr-labelled-platelet survival after treatment with placebo and the high-dose-aspirin/dipyridamole combination. The remaining seven patients (group II) had platelet-regeneration times measured after each of the four treatment periods. 3. Treatment of group I patients with the high-dose-aspirin/dipyridamole combination resulted in significant (P < 0·001) prolongation of platelet survival from 7·3 ± 0·2 (mean ± sem) days to 8·4 ± 0·1 days. 4. In group II patients, when compared with the mean placebo result of 7·2 ± 0·2 days, the mean aspirin-labelled-platelet-regeneration time was significantly (P < 0·01) longer only after high-dose-aspirin/dipyridamole (9·8 ± 0·5 days) but not after low-dose-aspirin/dipyridamole (8·3 ± 0·5 days) or aspirin alone (7·3 ± 0·3 days). 5. These results suggest that it may be premature to consider reducing the dose of aspirin in aspirin/dipyridamole combinations below 1 g/day when used as antithrombotic therapy.

scholarly journals Effects of Various Doses of Caffeine Ingestion on Intermittent Exercise Performance and Cognition

2020 ◽  
Vol 10 (9) ◽  
pp. 595 ◽  
Author(s):  
Cuicui Wang ◽  
Yuechuan Zhu ◽  
Cheng Dong ◽  
Zigui Zhou ◽  
Xinyan Zheng
Keyword(s):  
Stroop Task ◽  
Exercise Performance ◽  
Power Output ◽  
Intermittent Exercise ◽  
Peak Power Output ◽  
High Dose ◽  
Double Blind ◽  
Caffeine Ingestion ◽  
Positive Effects ◽  
The Mean

To date, no study has examined the effects of caffeine on prolonged intermittent exercise performance that imitates certain team-sports, and the suitable concentration of caffeine for improved intermittent exercise performance remains elusive. The purpose of the present cross-over, double-blind preliminary study was to investigate effects of low, moderate, and high doses of caffeine ingestion on intermittent exercise performance and cognition. Ten males performed a familiarization session and four experimental trials. Participants ingested capsules of placebo or caffeine (3, 6, or 9 mg/kg) at 1 h before exercise, rested quietly, and then performed cycling for 2 × 30 min. The cycling protocol consisted of maximal power pedaling for 5 s (mass × 0.075 kp) every minute, separated by unloaded pedaling for 25 s and rest for 30 s. At pre-ingestion of capsules, 1 h post-ingestion, and post-exercise, participants completed the Stroop task. The mean power-output (MPO), peak power-output (PPO), and response time (RT) in the Stroop task were measured. Only 3 mg/kg of caffeine had positive effects on the mean PPO and MPO; 3 mg/kg caffeine decreased RTs significantly in the incongruent and congruent conditions. These results indicate that the ingestion of low-dose caffeine had greater positive effects on the participants’ physical strength during prolonged intermittent exercise and cognition than moderate- or high-dose caffeine.

scholarly journals The GH-2004 project: the response of IGF1 and type III pro-collagen to the administration of exogenous GH in non-Caucasian amateur athletes

2010 ◽  
Vol 163 (1) ◽  
pp. 45-54 ◽  
Author(s):  
Richard I G Holt ◽  
Ioulietta Erotokritou-Mulligan ◽  
Cathy McHugh ◽  
E Eryl Bassett ◽  
Christiaan Bartlett ◽  
...  
Keyword(s):  
Predominantly White ◽  
Low Dose ◽  
Maximal Response ◽  
High Dose ◽  
Double Blind ◽  
Men And Women ◽  
Amateur Athletes ◽  
Type Iii ◽  
Southampton General Hospital ◽  
Clinical Research Facility

ContextThe GH-2000 team proposed a method based on IGF1 and type III pro-collagen (P-III-P) to detect exogenously administered GH. As previous studies involved predominantly white European athletes, it is important to assess whether the response of these markers to recombinant human GH (rhGH) differs with ethnicity.ObjectiveTo examine the response of serum IGF1 and P-III-P and GH-2000 score to rhGH in non-Caucasian amateur athletes.DesignDouble-blind placebo-controlled rhGH administration study.SettingWellcome Trust Clinical Research Facility, Southampton General Hospital.SubjectsThe study included 31 male and 14 female amateur athletes of different ethnicities.InterventionThe subjects were assigned to treatment with placebo or 0.1 IU/kg per day (low dose) or 0.2 IU/kg per day (high dose) rhGH for 28 days. Blood was collected weekly during treatment and on days 35, 42 and 84 during the washout period. Serum IGF1 and P-III-P were measured, and GH-2000 score was calculated.ResultsIGF1, P-III-P and GH-2000 score rose in response to both low- and high-dose GH in both men and women. When compared with the Caucasian volunteers of the previous GH-2000 study, mean baseline and placebo-treated P-III-P and GH-2000 score were lower in GH-2004 men and women. Post-GH, however, peak IGF1 or P-III-P did not differ between studies but the peak GH-2000 score was lower in GH-2004 men. There was no difference between studies in the maximal change in IGF1, P-III-P and GH-2000 score in response to GH in either gender.ConclusionsThese data do not support a significant ethnic effect on the peak or maximal response to rhGH.

Lipid Responses in Mildly Hypertriglyceridemic Men and Women to Consumption of Docosahexaenoic Acid-Enriched Eggs

2003 ◽  
Vol 73 (5) ◽  
pp. 357-368 ◽  
Author(s):  
Maki ◽  
Van Elswyk ◽  
McCarthy ◽  
Seeley ◽  
Veith ◽  
...  
Keyword(s):  
Docosahexaenoic Acid ◽  
Density Lipoprotein ◽  
Serum Triglyceride ◽  
Hdl Cholesterol ◽  
Controlled Clinical Trial ◽  
Nuclear Magnetic Resonance Analysis ◽  
Double Blind ◽  
Men And Women ◽  
Cholesterol Levels ◽  
Ldl Particles

This randomized, double-blind, controlled clinical trial assessed lipid responses in mildly hypertriglyceridemic men and women to consumption of docosahexaenoic acid (DHA)-enriched eggs or ordinary chicken eggs. The study included 153 subjects aged 21–80 years, with serum triglyceride concentrations between 140 and 450 mg/dL, inclusive, and serum total cholesterol concentrations < 300 mg/dL. Subjects were randomly assigned to receive either DHA-enriched (147 mg DHA/egg) or ordinary eggs (20 mg DHA/egg), added to their usual diets for six weeks (10 eggs/week). Both treatments significantly lowered triglycerides and increased high-density lipoprotein (HDL) cholesterol levels from baseline; however, these changes were not significantly different between treatments. Low-density lipoprotein (LDL) cholesterol concentrations increased significantly in subjects who consumed DHA-enriched eggs (p = 0.047 vs. control). This increase was significantly higher than that observed with ordinary eggs. However, there was no significant increase in cholesterol carried by small, dense LDL particles, as determined by nuclear magnetic resonance analysis. Results of exploratory analyses suggest favorable effects of the DHA-enriched eggs over ordinary eggs on triglyceride and HDL cholesterol levels in subjects with body mass index ≥ 30 kg/m2; the DHA treatment produced a larger reduction in serum triglyceride concentration vs. ordinary eggs (–12.3 vs. 2.1%; p = 0.027), and there was a greater increase for HDLcholesterol in the DHA-enriched vs. ordinary egg group (5.0 vs. 1.1%; p = 0.040).

scholarly journals Efficacy and Safety of GHX02 in the Treatment of Acute Bronchitis and Acute Exacerbation of Chronic Bronchitis: A Phase Ⅱ, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Su Won Lee ◽  
Yee Ran Lyu ◽  
Si Yeon Kim ◽  
Won Kyung Yang ◽  
Seung Hyung Kim ◽  
...  
Keyword(s):  
Placebo Group ◽  
Standard Dose ◽  
Acute Bronchitis ◽  
Multicenter Trial ◽  
High Dose ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Treatment Groups ◽  
The Mean ◽  
Mean Differences

Acute bronchitis and acute exacerbations of chronic bronchitis (AECB) have cough and sputum as the main symptoms with a high prevalence and substantial economic burden. Although the demand for bronchitis treatment increases due to causes, such as air pollution, the appropriateness of antibiotic prescriptions and the effects of current symptomatic treatments for bronchitis are unclear. GHX02, which is a combined formulation containing four herbs, and has been clinically used for bronchitis in South Korea. We conducted a phase II, randomized, double-blind, and placebo-controlled, multicenter trial to evaluate its efficacy and safety. Patients with acute bronchitis or AECB were recruited and randomized to receive high-dose GHX02 (1920 mg/day), standard-dose GHX02 (960 mg/day), or placebo for 7 days. The primary outcome measure was the change in Bronchitis Severity Score (BSS) from baseline to Day 7. The secondary outcomes were the frequency of coughing fits, Questionnaire of Clinical Symptoms of Cough and Sputum (QCSCS), Leicester Cough Questionnaire (LCQ), Integrative Medicine Outcome Scale (IMOS), and Integrative Medicine Patient Satisfaction Scale (IMPSS). A total of 117 patients were randomized to parallel groups (38 in the high-dose GHX02, 41 in the standard-dose GHX02 group, and 38 in the placebo group). The mean differences in BSS from baseline to Day 7 in the treatment groups (4.2 ± 2.0 and 4.5 ± 1.8 in the high-dose GHX02 and standard-dose GHX02 groups, respectively) were higher than the placebo group (3.8 ± 2.1), p = 0.028. The mean differences in the frequency of coughing fits from baseline to Day 7 and IMPSS were better in the GHX02 treatment group than in the placebo group (standard-dose GHX02 group vs placebo group, p = 0.036). The QCSCS, LCQ, IMOS, and GHX02 of the treatment groups also showed more improvement than the placebo group, but there were no statistically significant differences between the groups. There were no severe adverse effects during the trial. This study supports that GHX02 is effective and safe for patients with bronchitis and provides the basis for progression to a phase III study.Clinical Trial Registration: [https://cris.nih.go.kr] WHO International Clinical Trials Registry Platform, Clinical Research Information Service [KCT0003665].

scholarly journals Effects of Grape Seed Proanthocyanidin Extract on Vascular Endothelial Function in Participants with Prehypertension: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2844 ◽  
Author(s):  
Tamami Odai ◽  
Masakazu Terauchi ◽  
Kiyoko Kato ◽  
Asuka Hirose ◽  
Naoyuki Miyasaka
Keyword(s):  
Dose Group ◽  
Grape Seed ◽  
High Dose Group ◽  
Controlled Study ◽  
High Dose ◽  
Vascular Endothelial ◽  
Vascular Endothelial Function ◽  
Double Blind ◽  
Grape Seed Proanthocyanidin ◽  
The Mean

This study aimed to investigate the effects of grape seed proanthocyanidin extract (GSPE) on blood pressure and vascular endothelial function in middle-aged Japanese adults with prehypertension. We conducted a randomized, double-blind, placebo-controlled study on 6 men and 24 women aged 40–64 years old. The participants were randomized to receive tablets containing either low-dose (200 mg/day) or high-dose (400 mg/day) GSPE, or placebo, for 12 weeks. Systolic and diastolic blood pressures (SBP and DBP, respectively), brachial flow-mediated dilation (FMD), and other cardiovascular parameters were measured before and after 4, 8, and 12 weeks of treatment. The mean SBP in the high-dose group significantly decreased by 13 mmHg after 12 weeks (P = 0.028), although FMD did not change. In an ad hoc analysis of non-smoking participants (n = 21), the mean SBP, DBP, stiffness parameter β, distensibility, incremental elastic modulus (Einc), and pulse wave velocity (PWV) also significantly improved in the high-dose group after 12 weeks. Changes in Einc and PWV from baseline to 12 weeks were significantly greater in the high-dose group than in the placebo group (Einc, P = 0.023; PWV, P = 0.03). GSPE consumption could help maintain vascular elasticity and normal blood pressure in this population.

The Effectiveness of Glycosaminoglycans in Peripheral Vascular Disease Therapy: A Clinical and Experimental Trial

1985 ◽  
Vol 13 (1) ◽  
pp. 40-47 ◽  
Author(s):  
C Corsi ◽  
L Bocci ◽  
C Cipriani ◽  
A Gazzini ◽  
E Marrapodi
Keyword(s):  
Vascular Disease ◽  
Peripheral Vascular Disease ◽  
Hdl Cholesterol ◽  
Disease Stage ◽  
High Dose ◽  
Double Blind Study ◽  
Peripheral Vascular ◽  
Double Blind ◽  
End Of Treatment ◽  
Disease Therapy

Thirty patients suffering from peripheral vascular disease (stage–II according to Fontaine) were included in a double-blind study aimed at assessing the efficacy of a high-dose glycosaminoglycan (GAG) (Sulodexide) both in terms of laboratory parameters, such as lipid metabolism and blood coagulation components, and instrumental procedures (strain-gauge plethysmography). Compared with the fifteen control patients (treated with placebo), the fifteen patients treated with Sulodexide showed a signficant decrease in blood triglycerides and fibrinogen as well as a significantly increased HDL-cholesterol, and positive instrumental changes: at the end of treatment Peak and Rest Flow values – and consequently also Winsor's index – were significantly increased only in patients treated with Sulodexide.

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