scholarly journals Daily intake of Citrus jabara fruit peel powder (Japanese Patent No. 5,323,127) improves allergy-like symptoms: A randomized double-blind parallel-group comparative study

2021 ◽  
Vol 5 (2) ◽  
pp. 21
Author(s):  
Seisho Azuma ◽  
Yoshinobu Murakami ◽  
Masahiko Taniguchi ◽  
Kimiye Baba ◽  
Toru Mima ◽  
...  
Keyword(s):  
Daily Intake ◽  
Safety Evaluation ◽  
Citrus Fruit ◽  
Oral Intake ◽  
High Dose ◽  
Life Questionnaire ◽  
Fruit Peel ◽  
Double Blind ◽  
Japanese Patent ◽  
Parallel Group

Citrus jabara (CJ) is a rare citrus fruit that used to grow naturally only in the southern part of the Kii Peninsula in Japan. Human intervention studies with oral intake of CJ fruit have shown its anti-allergic effects, but the testing method was a pre-post comparison study. In this study, we conducted a randomized, double-blind, parallel-group interventional study to evaluate the volume-dependent effects of oral intake of CJ fruit peel powder (Japanese Patent No. 5,323,127) on nasal and eye allergy-like symptoms. Ninety healthy adults were allocated to three groups and given test foods containing 1,000, 500, and 0 mg of CJ peel powder, with one packet per day for 4 weeks. After excluding those who dropped out or deviated from the study protocol, 73 were included in the efficacy analysis and 86 in the safety analysis. The high-dose group (1,000 mg/day) was significantly lower than the placebo group in the scores of “nasal and eye symptoms” at week 4, and “blocked nose” at weeks 2 and 4 in the evaluation of question I of Japanese Rhino-conjunctivitis Quality of Life Questionnaire (JRQLQ No. 1). The changes in scores (difference from the pre-observation period) on the Nasal and Eye Symptom Questionnaire showed a dose-dependent reduction in rhinorrhea. In the safety evaluation, there were no significant differences in examinations of physiology, hematology, and blood biochemistry between the groups, and no adverse events attributable to the test foods were observed. These results suggest that intake of CJ peel powder can alleviate allergy-like symptoms.

scholarly journals Effect of 12-Week Daily Intake of the High-Lycopene Tomato (Solanum Lycopersicum), a Variety Named “PR-7”, on Lipid Metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Nutrients ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 1177 ◽  
Author(s):  
Mie Nishimura ◽  
Naoki Tominaga ◽  
Yuko Ishikawa-Takano ◽  
Mari Maeda-Yamamoto ◽  
Jun Nishihira
Keyword(s):  
Placebo Group ◽  
Lipid Metabolism ◽  
Solanum Lycopersicum ◽  
Biological Effects ◽  
Daily Intake ◽  
Vital Signs ◽  
Density Lipoprotein ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group

Tomato (Solanum lycopersicum) is a rich source of lycopene, a carotenoid that confers various positive biological effects such as improved lipid metabolism. Here, we conducted a randomized, double-blind, placebo-controlled, parallel-group comparative study to investigate the effects of regular and continuous intake of a new high-lycopene tomato, a variety named PR-7, for 12 weeks, based on 74 healthy Japanese subjects with low-density lipoprotein cholesterol (LDL-C) levels ≥120 to <160 mg/dL. The subjects were randomly assigned to either the high-lycopene tomato or placebo (lycopene-free tomato) group. Each subject in the high-lycopene group ingested 50 g of semidried PR-7 (lycopene, 22.0–27.8 mg/day) each day for 12 weeks, while subjects in the placebo group ingested placebo semidried tomato. Medical interviews were conducted, vital signs were monitored, body composition was determined, and blood and saliva samples were taken at weeks 0 (baseline), 4, 8, and 12. The primary outcome assessed was LDL-C. The intake of high-lycopene tomato increased lycopene levels in this group compared to levels in the placebo group (p < 0.001). In addition, high-lycopene tomato intake improved LDL-C (p = 0.027). The intake of high-lycopene tomato, PR-7, reduced LDL-C and was confirmed to be safe.

scholarly journals High dose saccharin supplementation does not induce gut microbiota dysbiosis or glucose intolerance in healthy humans and mice

2020 ◽  
Author(s):  
Joan Serrano ◽  
Kathleen R Smith ◽  
Audra L Crouch ◽  
Vandana Sharma ◽  
Fanchao Yi ◽  
...  
Keyword(s):  
Glucose Tolerance ◽  
Gut Microbiota ◽  
Glucose Intolerance ◽  
Ex Vivo ◽  
Daily Intake ◽  
Sweet Taste ◽  
High Dose ◽  
Double Blind ◽  
Genetic Ablation ◽  
Healthy Humans

Abstract Background : Non-caloric artificial sweeteners (NCAS) are widely used as a substitute for dietary sugars to control body weight or glycemia. Paradoxically, saccharin and other NCAS have been reported to induce glucose intolerance in mice fed a high-fat diet and in a subset of humans by directly inducing unfavorable changes in gut microbiota. These findings have raised concerns about NCAS and called into question their broad use. Whether these results can be generalized to healthy populations consuming conventional diets is unknown. It is also unclear how different NCAS, that do not share a common chemical structure, can produce identical direct effects on gut microbiota. A common feature of all NCAS is their strong affinity for sweet taste receptors (STRs) which are expressed in the intestine. However, their role in mediating NCAS-induced effects has not been addressed. Results : We conducted a double-blind, placebo-controlled, parallel arm study exploring the effects of saccharin on gut microbiota and glucose tolerance in healthy men and women. Participants were randomized to placebo, saccharin, lactisole (STR inhibitor), or saccharin with lactisole administered in capsules twice daily to achieve the maximum acceptable daily intake for two weeks. In parallel, we performed a ten-week study administering high-dose saccharin in the drinking water of chow-fed mice with genetic ablation of STRs (T1R2-KO) and wild-type (WT) littermate controls. In humans and mice alike, none of the interventions affected glucose or hormonal responses to a glucose tolerance test, nor ex vivo glucose absorption in mice. Similarly, saccharin supplementation did not alter microbial diversity or abundance at any taxonomic level in humans or mice. No treatment effects were also noted in readouts of microbial activity such as fecal metabolites or short chain fatty acids (SCFA). However, compared to WT, T1R2-KO mice were protected from age-dependent increases in fecal SCFA and the development of glucose intolerance.

Abstract 11532: Randomized Trial of the Association Between Low Dose Statins and Nutraceuticals in High intensity Statin. intolerRant patiENts With Very High Risk Coronary Artery disease (ADHERENCE)

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
giuseppe marazzi ◽  
francesco pelliccia ◽  
maurizio volterrani ◽  
giuseppe campolongo ◽  
salvatore rosanio ◽  
...  
Keyword(s):  
High Risk ◽  
Low Dose ◽  
Primary Objective ◽  
High Dose ◽  
Red Yeast Rice ◽  
Atherosclerotic Cardiovascular Disease ◽  
Double Blind ◽  
Parallel Group ◽  
Artery Disease ◽  
Treatment Tolerance

Background: Several trials have shown that in patients (pts) with atherosclerotic cardiovascular disease, reduction of LDL-C level with statin is associated with significant reductions in mortality and cardiovascular events. In clinical practice, however, high dose statin (HDS) treatment is often discontinued by pts due to side effects. Indeed, in statin intolerant pts alternative therapies such as nutraceuticals are available. Purpose: The primary objective of this study is to compare the efficacy and tollerability of low dose statin (LDS) therapy vs the association between a LDS and a nutraceuticals in HDS intollerant pts with CAD deemed to be at high risk. Methods: A randomised, prospective, parallel group, double blind trial was designed. The inclusion criteria were pts with CAD that underwent to PCI and that do not achieved at least a 50% reduction in LDL C and were HDS intolerant in treatment with LDS. These pts were randomized 1:1 in 2 groups: group NS received an association with LDS and a commercially available nutraceutical pill (1 tablet/day containing red yeast rice 200 mg, policosanol 10 mg and berberine 500 mg) and group S continued LDS (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin or 5 mg/day rosuvastatin). At baseline and after 3 months all pts underwent to clinical evaluation and blood exams. Results: 100 pts were consecutively enrolled. Baseline clinical features and lipid profiles were similar between groups. At the 3° month, the 2 groups significantly differed for LDL-C, total cholesterol and triglycerides, with lower levels in the NS group than in the S group; also, the 2 groups differed for HDL-C values but not significantly, with higher levels in the NS group than in the S group (Table 1). Morever, in both group the treatment tolerance was high: in each groups only 3 pts discontinued therapy. Conclusion: In pts with CAD and HDS intolerant, a treatment with LDS and Nutraceuticals can be a reliable treatment option. (clinicaltrials.gov: NCT02001883)

Sumatriptan in the Treatment of Acute Migraine With Aura

Cephalalgia ◽  
1992 ◽  
Vol 12 (1) ◽  
pp. 39-44 ◽  
Author(s):  
M Banerjee ◽  
LJ Findley
Keyword(s):  
Migraine With Aura ◽  
Acute Treatment ◽  
Bitter Taste ◽  
Placebo Response ◽  
High Dose ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group ◽  
Group Randomized Trial ◽  
High Incidence

The efficacy of the selective 5HT1-like agonist sumatriptan in acute treatment of classical migraine (i.e. migraine with aura) was assessed in a double-blind, placebo-controlled, parallel group randomized trial. An oral dose of 200 mg was chosen on the basis of the efficacy rates achieved (70–85%) with 70–280 mg in open studies (1, 2). The dose of 200 mg was also chosen for the study because preliminary data from an oral pilot study indicated that efficacy increased with increasing dose up to 200 mg. Each patient was treated for a maximum of three separate attacks of migraine with aura within a three months' period. Three attacks were treated so that we could examine consistency of response across more than one attack. For attack 1,200 mg sumatriptan was significantly more effective, safe and well tolerated than placebo at relieving headache 2 h after treatment was given ( p = 0.023). In subsequent attacks, i.e. in attacks 2 and 3, there was no such significant effect of sumatriptan compared with placebo in relieving headache. This reduced efficacy of sumatriptan in the second and third attacks may be due to a high incidence of vomiting induced by the high dose of dispersible formulation and also by the bitter taste of the tablets. In addition, there was an increase in placebo response in attacks 2 and 3 compared to the first attack.

scholarly journals Effects of daily intake of Harudori-kombu: A randomized, double-blind, placebo-controlled, parallel-group study

2019 ◽  
Vol 9 (4) ◽  
pp. 205
Author(s):  
Mie Nishimura ◽  
Miwako Sugawara ◽  
Masafumi Kudo ◽  
Yasunori Kinoshita ◽  
Hiroyuki Yoshino ◽  
...  
Keyword(s):  
Body Fat ◽  
Low Density Lipoprotein ◽  
Daily Intake ◽  
Density Lipoprotein ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group Study ◽  
Parallel Group ◽  
Medical Interviews ◽  
Functional Components

Background: Kombu (Laminariaceae) is traditionally consumed in Japan. “Harudori-kombu” is young kombu harvested in spring. Harudori-kombu contains functional components, such as fucoxanthin—a carotenoid—which confer various biological effects.Methods: In this study, we investigated effects of the continuous intake of dried Harudori-kombu (2.0 g/day) for 6 weeks. We conducted a randomized, double-blind, placebo-controlled, parallel-group study including 70 healthy Japanese subjects with body mass index between 22 and 30 kg/m2 and low-density lipoprotein cholesterol levels between 120 and 160 mg/dL. Subjects were randomly assigned to either Harudori-kombu group or placebo group. Subjects ingested 9 capsules per day for 6 weeks. We conducted medical interviews, vital sign examinations, and blood sampling at weeks 0 (baseline), 2, and 6. Moreover, we assessed body composition at weeks 0 and 6.Results: Harudori-kombu intake did not improve the lipid profile but did reduce body fat. In addition, adiponectin levels were significantly improved.Conclusions: Harudori-kombu intake showed beneficial health effects, such as reduction in body fat and improvement of adiponectin levels, and was deemed safe at the dose administered in this study.

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