A Pilot Study: Effects of Kombu Intake on Lifestyle-related Diseases -Possibility that Kombu Intake is Effective in Individuals with Abnormally High Serum Triglyceride Levels-

2019 ◽  
Vol 25 (6) ◽  
pp. 827-834 ◽  
Author(s):  
Shin Nishiumi ◽  
Yoshihiro Izumi ◽  
Takashi Kobayashi ◽  
Masaru Yoshida
Keyword(s):  
Pilot Study ◽  
Serum Triglyceride ◽  
High Serum ◽  
Lifestyle Related Diseases

scholarly journals The Effects of a Co-design Based Invitation Strategy on Participation in a Preventive Health Check Program: A Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Trine Thilsing ◽  
Lars Bruun Larsen ◽  
Anders Larrabee Sonderlund ◽  
Signe Skaarup Andreassen ◽  
Jeanette Reffstrup Christensen ◽  
...  
Keyword(s):  
Primary Care ◽  
At Risk ◽  
Pilot Study ◽  
Educational Attainment ◽  
Design Process ◽  
Family Income ◽  
Target Group ◽  
Control Group ◽  
Participation Rates ◽  
Lifestyle Related Diseases

BACKGROUND Primary-care-based preventive programs that aim to reduce morbidity and mortality from lifestyle-related diseases often suffer from low to moderate participation rates. Improving participation rates is essential to clinical effect and cost effectiveness. In 2016-2017 we conducted the first pilot study (TOF pilot1) testing a primary-care-based preventive program (the TOF intervention) comprising systematic identification of individuals at risk of lifestyle-related diseases, and subsequent targeted preventive services offered to the at-risk population. A total of 40.2% of the invited patients consented to take part in the study with the highest participation rates obtained among women and patients with higher income, education, and employment. OBJECTIVE The aim of this study was to evaluate the effect of a revised invitation strategy targeting men and patients of low educational attainment on overall participation rate and participant demography. METHODS This study was embedded in the second pilot study (initiated in October 2018) testing an adjusted TOF intervention (TOF pilot2). The revised invitation strategy comprised a pre-notification postcard and a new invitation targeting men and patients of low educational attainment. The new invitation was developed in a co-design process involving communication professionals and target group representatives. The study sample consisted of 4633 patients aged 29-59 years and residing in two municipalitites in the Region of Southern Denmark. Eligible patients were randomly assigned to four invitation groups receiving either 1) The original invitation used in TOF pilot1 (Control group), 2) The original invitation and the pre-notification postcard, 3) The new, revised invitation and the pre-notification postcard, or 4) The new invitation only. RESULTS Overall, 2171 (46.9%) patients consented to participate. Compared to receiving the original invitation alone, participation rates increased significantly for those groups who received the new revised invitation alone (p<.001), the new invitation with the pre-notification postcard (p<.001), and the original invitation with the pre-notification postcard (p<.001). Participation across the three intervention groups was increased among women as well as men, patients of high as well as low educational attainment and patients of low as well as higher family income. The largest relative increase in participation was seen among males, patients with low educational attainment, and patients with low family income. No significant increase in participation was detected among unemployed patients and patients of non-Danish origin. CONCLUSIONS The results showed that significant improvements in participation rates can be obtained from pre-notification postcards and invitations that have undergone a co-design process, involving communication professionals and target group representatives. Although firm conclusions can not be made from the present study, the apparent increased effect on participation among men and patients of low socioeconomic status may be relevant in programs that aim to reduce inequality in health. In order to reach the most socioeconomically disadvantaged groups, the invitation strategy should probably be combined with other more individual-oriented recruitment approaches. CLINICALTRIAL Clinical Trial Gov (NCT03913585)

scholarly journals A Dietary Intervention of Bioactive Enriched Foods Aimed at Adults at Risk of Metabolic Syndrome: Protocol and Results from PATHWAY-27 Pilot Study

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1814 ◽  
Author(s):  
Achim Bub ◽  
Corinne Malpuech-Brugère ◽  
Caroline Orfila ◽  
Julien Amat ◽  
Alice Arianna ◽  
...  
Keyword(s):  
Risk Factors ◽  
Metabolic Syndrome ◽  
Pilot Study ◽  
Dietary Intervention ◽  
Adult Population ◽  
Serum Triglyceride ◽  
Beta Glucan ◽  
Double Blind ◽  
Pilot Studies ◽  
Increased Risk

Around a quarter of the global adult population have metabolic syndrome (MetS) and therefore increased risk of cardiovascular mortality and diabetes. Docosahexaenoic acid, oat beta-glucan and grape anthocyanins have been shown to be effective in reducing MetS risk factors when administered as isolated compounds, but their effect when administered as bioactive-enriched foods has not been evaluated. Objective: The overall aim of the PATHWAY-27 project was to evaluate the effectiveness of bioactive-enriched food consumption on improving risk factors of MetS. A pilot study was conducted to assess which of five bioactive combinations provided within three different food matrices (bakery, dairy or egg) were the most effective in adult volunteers. The trial also evaluated the feasibility of production, consumer acceptability and gastrointestinal tolerance of the bioactive-enriched food. Method: The study included three monocentric, parallel-arm, double-blind, randomised, dietary intervention trials without a placebo. Each recruiting centre tested the five bioactive combinations within a single food matrix. Results: The study was completed by 167 participants (74 male, 93 female). The results indicated that specific bioactive/matrix combinations have effects on serum triglyceride or HDL-cholesterol level without adverse effects. Conclusion: The study evidenced that bioactive-enriched food offers a promising food-based strategy for MetS prevention, and highlighted the importance of conducting pilot studies.

scholarly journals Marked effects of novel selective peroxisome proliferator-activated receptor α modulator, pemafibrate in severe hypertriglyceridemia: preliminary report

2020 ◽  
Vol 19 (1) ◽  
Author(s):  
Chie Iitake ◽  
Daisaku Masuda ◽  
Masahiro Koseki ◽  
Shizuya Yamashita
Keyword(s):  
Acute Pancreatitis ◽  
Serum Triglyceride ◽  
High Serum ◽  
Peroxisome Proliferator ◽  
Serious Adverse Events ◽  
Serum Triglycerides ◽  
Oral Tablet ◽  
Peroxisome Proliferator Activated Receptor ◽  
Severe Hypertriglyceridemia ◽  
Potential Efficacy

Abstract Background Currently available treatments have only been partly successful in patients with severe hypertriglyceridemia, including those with high serum triglycerides above 1,000 mg/dL (11.3 mmol/L), who often suffer from acute pancreatitis. Pemafibrate is a novel selective peroxisome proliferator-activated receptor α modulator (SPPARMα) which has been developed as an affordable oral tablet in Japan. We herein report the first three patients with severe hypertriglyceridemia who were successfully treated with pemafibrate. Methods Three patients with fasting serum triglyceride (TG) levels above 1,000 mg/dL (11.3 mmol/L) were treated with pemafibrate (0.2–0.4 mg/day, 0.1–0.2 mg BID). Results Serum TGs decreased from 2,000–3,000 mg/dL (22.6–33.9 mmol/L) to < 250 mg/dL (2.8 mmol/L) without adverse effects in all three patients. Serum TGs in Patient 1 and 2 decreased from 1,326 mg/dL (15.0 mmol/L) to 164 mg/dL (1.9 mmol/L) and from 2,040 mg/dL (23.1 mmol/L) to 234 mg/dL (2.6 mmol/L), respectively. Patient 3 with type 2 diabetes and 12.1% (109 mmol/mol) hemoglobin A1c had a TG level of 2,300 mg/dL (26.0 mmol/L). Even after glycemic control improved, TG remained high. After pemafibrate administration, TG decreased to 200 mg/dL (2.3 mmol/L). All patients showed no serious adverse events. Conclusions Pemafibrate demonstrated potential efficacy and safety for severe hypertriglyceridemia which may contribute to the prevention of acute pancreatitis, in a manner that can be easily prescribed and used as an oral tablet.

Can a Mediterranean diet reduce the effects of lipodystrophy syndrome in people living with HIV? A pilot randomised controlled trial

Sexual Health ◽  
2011 ◽  
Vol 8 (1) ◽  
pp. 43 ◽  
Author(s):  
Geraldine Wai Bik Ng ◽  
Una Man Shu Chan ◽  
Patrick Chung Ki Li ◽  
William C. W. Wong
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Mediterranean Diet ◽  
Controlled Trial ◽  
Serum Triglyceride ◽  
Fat Distribution ◽  
Diet Group ◽  
Low Fat ◽  
Low Fat Diet ◽  
Randomised Controlled

Background: HIV and highly active antiretroviral therapies have been associated with changes in individuals’ lipid profiles and fat distribution (lipodystrophy). A pilot study was conducted for a randomised controlled trial to evaluate whether lipodystrophy in HIV patients can be controlled by adopting the low-fat and low-cholesterol diet or the modified Mediterranean diet. Methods: Forty-eight HIV patients were randomised into two diet groups. Thirty-six (75%) completed the 1-year pilot study with regular dietetic consultations, during which time lipid levels, weight, body mass index and fat distribution were recorded. Differences between and within groups were determined. Results: Undesirable body fat changes in the low-fat diet group included decreases in tricep skinfold (from 19.9 mm to 15.4 mm (P = 0.03)), hip circumference (from 93.6 cm to 91.7 cm (P = 0.01)) but a significant increase in waist-to-hip ratio (from 0.87 to 0.89 (P = 0.003)). Serum cholesterol increased significantly in the Mediterranean diet group at 9 and 12 months (from 4.6 to 5.06 mmol L−1 (P = 0.03) and 5.12 mmol L−1 (P = 0.01)) with no obvious change in the low-fat diet group. Serum triglyceride levels remained the same in the Mediterranean diet group, whereas it increased from 1.9 to 3.22 mmol L−1 (P = 0.07) in the low-fat diet group. Conclusions: A Mediterranean diet seems to have an advantage over the low-fat diet in maintaining serum triglyceride levels and avoiding lipodystrophy, but this advantage was offset by a rise in cholesterol level. Several procedural and methodological issues were identified which must be rectified before a similar large-scale trial taking place.

A pilot study of liposomal irinotecan plus 5-FU/LV combined with paricalcitol in patients with advanced pancreatic cancer progressed on gemcitabine-based therapy.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. TPS793-TPS793
Author(s):  
Patrick Grierson ◽  
Andrea Wang-Gillam ◽  
Haeseong Park ◽  
Katrina Pedersen ◽  
Benjamin R. Tan ◽  
...  
Keyword(s):  
Vitamin D ◽  
Pilot Study ◽  
Tumor Microenvironment ◽  
Advanced Pancreatic Cancer ◽  
Primary Objective ◽  
High Serum ◽  
Ductal Adenocarcinoma ◽  
Combination Regimen ◽  
Second Line ◽  
Liposomal Irinotecan

TPS793 Background: Pancreatic ductal adenocarcinoma (PDAC) is predicted to be the second leading cause of cancer-related death by 2030, and is characterized by resistance to chemo- and radiotherapy and a highly fibrotic tumor microenvironment. Front-line therapies for advanced PDAC include FOLFIRINOX and gemcitabine/nab-paclitaxel with median overall survival ranging from 8.5 to 11 months. After progression on gemcitabine-containing therapy, 5-FU/LV/liposomal irinotecan is a standard second-line option, however outcomes are still poor. Retrospective studies demonstrate superior survival of advanced PDAC in patients with high serum levels of 25(OH) vitamin D. Notably, the PDAC tumor microenvironment is enriched in cancer-associated fibroblasts that favorably respond to vitamin D, prolonging survival in combination with chemotherapy in mouse models. Furthermore, vitamin D suppresses catabolism of irinotecan in gastrointestinal cancer cells, potentiating its efficacy. Therefore, we are conducing an investigator-initiated study of 5FU/LV/liposomal irinotecan with paricalcitol as second-line therapy in advanced PDAC. Methods: This is a pilot study of 5FU/LV/liposomal irinotecan combined with paricalcitol in patients with advanced PDAC progressed on gemcitabine-based therapy. All patients receive liposomal irinotecan, LV, 5-FU and paricalcitol. Liposomal irinotecan is given at 70 mg/m2 IV over 90 minutes, LV at 400 mg/m2 IV over 30 minutes, and 5-FU at 2400 mg/m2 continuous IV infusion over 46 hours, on Day 1 of each 14-day cycle. Paricalcitol IV infusion will precede the above, given according to assigned cohort (75 mcg weekly or 7 mcg/kg weekly). The primary objective of this study is to determine the tolerability between two different dose levels of paricalcitol added to the combination regimen of 5-FU/LV/liposomal irinotecan in patients with advanced PDAC. Secondary objectives are measures of efficacy (ORR, PFS, OS, CA19-9 biochemical response rate). Clinical trial information: NCT03883919.

Abstract W MP78: Intravascular Volume Delpetion in Hypertensive ED Stroke Patients

Stroke ◽  
2015 ◽  
Vol 46 (suppl_1) ◽  
Author(s):  
Christopher Lewandowski ◽  
Joseph Miller ◽  
Lauren Rodriquez ◽  
Julian Suszanski ◽  
Jessica Levely
Keyword(s):  
Pilot Study ◽  
Volume Expansion ◽  
Clinical Information ◽  
High Serum ◽  
Volume Status ◽  
Stroke Patients ◽  
Volume Depletion ◽  
Clinical Indicators ◽  
Laboratory Markers ◽  
The Mean

Objective: The hypertensive response in acute stroke may mask patients who could be volume depleted. Our objective was to determine the incidence of stroke patients that are volume depleted despite hypertension. This is a pilot study using sonographic markers of volume status as compared to common clinical indicators of volume status. Methods: This was a prospective cohort study of suspected ischemic stroke patients with a NIHSS ≥ 4 and symptoms onset < 24 hours. Exclusion criteria were pregnancy, age < 18, or ICH. Trained investigators performed a sonographic assessment of volume status. An IVC collapsibility index (IVC-CI) > 50% was used to define volume depletion. Investigators collected demographic and clinical information, and laboratory markers of dehydration (elevated blood urea nitrogen to creatinine ratio, hemoconcentration or high serum osmolality). A standardized questionnaire was given to treating clinicians who were blinded to the IVC-CI. They indicated their assessment of the patient's volume status. The analysis excluded subjects ultimately diagnosed with a stroke mimic. Analysis incorporated descriptive and regression statistics using SAS 9.3. The local IRB approved the study. Results: 23 subjects were enrolled, 4 had stroke mimics and were excluded from analysis. Mimics consisted of psychogenic disorders and myelopathy. The mean age was 64 years, 89% were Black, 68% female, and 95% had preexisting HTN. The mean NIHSS was 9.2, the mean time from symptom onset 309 minutes and the mean presenting SBP 170 ± 31 mmHg. 68% of subjects had a cortical infarct on MRI and the remaining had lacunar infarcts. The mean IVC-CI was 70 ± 21% and 84% (95% CI 68 - 100%) of subjects had IVC-CI > 50%. Laboratory markers of dehydration were present in 5% of subjects. Treating physicians classified 29% as subjects as hypovolemic. There was no correlation between IVC-CI and SBP, NIHSS, infarct location or laboratory markers of dehydration (r = 0.04 - 0.29, p > 0.23). Conclusions: This pilot study suggests that despite being hypertensive, the majority of ED stroke patients have US indications of volume depletion and may be able to tolerate volume expansion. Future studies may identify which patients have improvement in cerebral perfusion with volume expansion.

High serum coenzyme Q10, positively correlated with age, selenium and cholesterol, in Inuit of Greenland. A pilot study

BioFactors ◽  
1999 ◽  
Vol 9 (2-4) ◽  
pp. 319-323 ◽  
Author(s):  
H. S. Pedersen ◽  
S. A. Mortensen ◽  
M. Rohde ◽  
Y. Deguchi ◽  
G. Mulvad ◽  
...  
Keyword(s):  
Pilot Study ◽  
Coenzyme Q10 ◽  
High Serum

scholarly journals Association of Low Serum Adiponectin Levels with Aortic Arterial Stiffness in Patients with Type 2 Diabetes

2019 ◽  
Vol 8 (6) ◽  
pp. 887 ◽  
Author(s):  
Cian-Huei Shih ◽  
Bang-Gee Hsu ◽  
Jia-Sian Hou ◽  
Du-An Wu ◽  
Yi-Maun Subeq
Keyword(s):  
Arterial Stiffness ◽  
Independent Predictor ◽  
Serum Triglyceride ◽  
High Serum ◽  
Serum Adiponectin ◽  
Multivariable Logistic Regression Analysis ◽  
Model Assessment ◽  
Type 2 Dm ◽  
Estimated Glomerular Filtration Rates

Adiponectin, an anti-inflammatory and anti-atherogenic protein, affects glucose metabolism. High serum adiponectin levels are associated with decreased diabetes mellitus (DM) risks. Aortic arterial stiffness (AS) is associated with cardiovascular disease and mortality in type 2 DM patients. We assessed the association between adiponectin levels and aortic AS in type 2 DM patients. We measured serum adiponectin levels in 140 volunteers with type 2 DM and assigned patients with carotid–femoral pulse wave velocity (cfPWV) >10 m/s to the aortic AS group (n = 54, 38.6%). These patients had higher systolic (p = 0.001) and diastolic (p = 0.010) blood pressures; body fat masses (p = 0.041); serum triglyceride (p = 0.026), phosphorus (p = 0.037), and insulin (p = 0.040) levels; and homeostasis model assessment of insulin resistance values (p = 0.029) and lower estimated glomerular filtration rates (p = 0.009) and serum adiponectin levels (p = 0.001) than controls. Multivariable logistic regression analysis adjusted for confounders showed serum adiponectin levels (OR 0.922; 95% CI, 0.876–0.970; p = 0.002) as an independent predictor of aortic AS. Multivariable forward stepwise linear regression analyses showed that serum adiponectin levels (β = −0.283, adjusted R2 change: 0.054, p < 0.001) were negatively associated with cfPWV. Thus, serum adiponectin level is an independent predictor of aortic AS in type 2 DM patients.

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