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Efficacy and Safety of Peppermint Oil in a Randomized, Double-Blind Trial of Patients With Irritable Bowel Syndrome.
Weerts, ZZRM, Masclee, AAM, Witteman, BJM, Clemens, CHM, Winkens, B, Brouwers, JRBJ, Frijlink, HW, Muris, JWM, De Wit, NJ, Essers, BAB, et al
Gastroenterology. 2020;(1):123-136
Abstract
BACKGROUND & AIMS Peppermint oil is frequently used to treat irritable bowel syndrome (IBS), despite a lack of evidence for efficacy from high-quality controlled trials. We studied the efficacy and safety of small-intestinal-release peppermint oil in patients with IBS and explored the effects of targeted ileocolonic-release peppermint oil. METHODS We performed a double-blind trial of 190 patients with IBS (according to Rome IV criteria) at 4 hospitals in The Netherlands from August 2016 through March 2018; 189 patients were included in the intent-to-treat analysis (mean age, 34.0 years; 77.8% female; 57.7% in primary care), and 178 completed the study. Patients were randomly assigned to groups given 182 mg small-intestinal-release peppermint oil, 182 mg ileocolonic-release peppermint oil, or placebo for 8 weeks. The primary endpoint was abdominal pain response, as defined by the US Food and Drug Administration: at least a 30% decrease in the weekly average of worst daily abdominal pain compared with baseline in at least 4 weeks. The co-primary endpoint was overall relief of IBS symptoms, as defined by the European Medicines Agency. Secondary endpoints included abdominal pain, discomfort, symptom severity, and adverse events. RESULTS Abdominal pain response did not differ significantly between the peppermint oil and placebo groups: 29 of 62 patients in the small-intestinal-release peppermint oil group had a response (46.8%, P = .170 vs placebo), 26 of 63 patients in the ileocolonic-release peppermint oil group had a response (41.3%, P = .385 vs placebo), and 22 of 64 patients in the placebo group had a response (34.4%). We did not find differences among the groups in overall relief (9.7%, P = .317 and 1.6%, P = .351 vs 4.7% for placebo). The small intestinal peppermint oil did, however, produce greater improvements than placebo in secondary outcomes of abdominal pain (P = .016), discomfort (P = .020), and IBS severity (P = .020). Adverse events, although mild, were more common in both peppermint oil groups (P < .005). CONCLUSIONS In a randomized trial of patients with IBS, we found that neither small-intestinal-release nor ileocolonic-release peppermint oil (8 weeks) produced statistically significant reductions in abdominal pain response or overall symptom relief, when using US Food and Drug Administration/European Medicines Agency recommended endpoints. The small-intestinal-release peppermint oil did, however, significantly reduce abdominal pain, discomfort, and IBS severity. These findings do not support further development of ileocolonic-release peppermint oil for treatment of IBS. Clinicaltrials.gov, Number: NCT02716285.
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Is the metabolic syndrome inversely associates with butter, non-hydrogenated- and hydrogenated-vegetable oils consumption: Tehran lipid and glucose study.
Hosseinpour-Niazi, S, Mirmiran, P, Hosseini-Esfahani, F, Azizi, F
Diabetes research and clinical practice. 2016;:20-29
Abstract
AIM: The aim of this study was to investigate the association between hydrogenated- (HVOs) and non-hydrogenated vegetable oils (non-HVOs) and butter and the metabolic syndrome (MetS) after 3-years of follow-up in adults. METHODS This study was conducted between 2006-2008 and 2009-2011 within the framework of the Tehran Lipid and Glucose Study, on 1582 adults, aged 19-84 years. Intakes of HVOs, non-HVOs and butter were assessed by a validated semi-quantitative food frequency questionnaire. Based on the consumption of food rich in fat including HVOs, non-HVOs and butter, participants were categorized to consumers and non-consumers. RESULTS Of 1582 participants during a 3-year follow-up, 15.2% developed MetS. Non-consumption of butter was associated with lower MetS risk compared with its consumption. Among consumers of food rich in fat, intake of HVOs and butter were associated with an increased risk of MetS; ORs in the final multivariate model were 2.70 (95% CI: 1.52-4.78) for HVOs and 2.03 (95% CI: 1.20-3.41) for butter, in the highest, compared to the lowest category of dietary intakes. Intake of non-HVOs was not associated with risk of MetS. CONCLUSIONS Consumption of HVOs and butter were positively associated with an increase risk of MetS.
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Malian children with moderate acute malnutrition who are treated with lipid-based dietary supplements have greater weight gains and recovery rates than those treated with locally produced cereal-legume products: a community-based, cluster-randomized trial.
Ackatia-Armah, RS, McDonald, CM, Doumbia, S, Erhardt, JG, Hamer, DH, Brown, KH
The American journal of clinical nutrition. 2015;(3):632-45
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BACKGROUND Moderate acute malnutrition (MAM), defined as weight-for-length z score between -3 and -2 or midupper arm circumference between 11.5 and 12.5 cm, affects ∼33 million children aged <5 y worldwide. OBJECTIVE The objective was to compare the effects of 4 dietary supplements for the treatment of MAM. DESIGN Twelve community health centers in rural Mali were randomly assigned to provide to 1264 MAM children aged 6-35 mo one of 4 dietary supplements containing ∼500 kcal/d for 12 wk: 1) ready-to-use, lipid-based supplementary food (RUSF); 2) special corn-soy blend (CSB++); 3) locally processed, fortified flour (Misola); or 4) locally milled flours plus oil, sugar, and micronutrient powder (LMF). RESULTS In total, 1178 children (93.2%) completed the study. The adjusted mean (95% CI) change in weight (kg) from baseline was greater with RUSF than with the locally processed blends and was intermediate with CSB++ [1.16 (1.08, 1.24) for RUSF, 1.04 (0.96, 1.13) for CSB++, 0.91 (0.82, 0.99) for Misola, and 0.83 (0.74, 0.92) for LMF; P < 0.001]. For length change, RUSF and CSB++ differed significantly from LMF. Sustained recovery rates were higher with RUSF (73%) than with Misola (61%) and LMF (58%), P < 0.0001; CSB++ recovery rates (68%) did not differ from any of the other groups. CONCLUSIONS RUSF was more effective, but more costly, than other dietary supplements for the treatment of MAM; CSB++ yielded intermediate results. The benefits of treatment should be considered in relation to product costs and availability.
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Olive Oil Polyphenols Decrease LDL Concentrations and LDL Atherogenicity in Men in a Randomized Controlled Trial.
Hernáez, Á, Remaley, AT, Farràs, M, Fernández-Castillejo, S, Subirana, I, Schröder, H, Fernández-Mampel, M, Muñoz-Aguayo, D, Sampson, M, Solà, R, et al
The Journal of nutrition. 2015;(8):1692-7
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BACKGROUND Olive oil polyphenols have shown protective effects on cardiovascular risk factors. Their consumption decreased oxidative stress biomarkers and improved some features of the lipid profile. However, their effects on LDL concentrations in plasma and LDL atherogenicity have not yet been elucidated. OBJECTIVE Our objective was to assess whether the consumption of olive oil polyphenols could decrease LDL concentrations [measured as apolipoprotein B-100 (apo B-100) concentrations and the total number of LDL particles] and atherogenicity (the number of small LDL particles and LDL oxidizability) in humans. METHODS The study was a randomized, cross-over controlled trial in 25 healthy European men, aged 20-59 y, in the context of the EUROLIVE (Effect of Olive Oil Consumption on Oxidative Damage in European Populations) study. Volunteers ingested 25 mL/d raw low-polyphenol-content olive oil (LPCOO; 366 mg/kg) or high-polyphenol-content olive oil (HPCOO; 2.7 mg/kg) for 3 wk. Interventions were preceded by 2-wk washout periods. Effects of olive oil polyphenols on plasma LDL concentrations and atherogenicity were determined in the sample of 25 men. Effects on lipoprotein lipase (LPL) gene expression were assessed in another sample of 18 men from the EUROLIVE study. RESULTS Plasma apo B-100 concentrations and the number of total and small LDL particles decreased (mean ± SD: by 5.94% ± 16.6%, 11.9% ± 12.0%, and 15.3% ± 35.1%, respectively) from baseline after the HPCOO intervention. These changes differed significantly from those after the LPCOO intervention, which resulted in significant increases of 6.39% ± 16.6%, 4.73% ± 22.0%, and 13.6% ± 36.4% from baseline (P < 0.03). LDL oxidation lag time increased by 5.0% ± 10.3% from baseline after the HPCOO intervention, which was significantly different only relative to preintervention values (P = 0.038). LPL gene expression tended to increase by 26% from baseline after the HPCOO intervention (P = 0.08) and did not change after the LPCOO intervention. CONCLUSION The consumption of olive oil polyphenols decreased plasma LDL concentrations and LDL atherogenicity in healthy young men. This trial was registered at www.controlled-trials.com as ISRCTN09220811.
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Olive oil intake and risk of cardiovascular disease and mortality in the PREDIMED Study.
Guasch-Ferré, M, Hu, FB, Martínez-González, MA, Fitó, M, Bulló, M, Estruch, R, Ros, E, Corella, D, Recondo, J, Gómez-Gracia, E, et al
BMC medicine. 2014;:78
Abstract
BACKGROUND It is unknown whether individuals at high cardiovascular risk sustain a benefit in cardiovascular disease from increased olive oil consumption. The aim was to assess the association between total olive oil intake, its varieties (extra virgin and common olive oil) and the risk of cardiovascular disease and mortality in a Mediterranean population at high cardiovascular risk. METHODS We included 7,216 men and women at high cardiovascular risk, aged 55 to 80 years, from the PREvención con DIeta MEDiterránea (PREDIMED) study, a multicenter, randomized, controlled, clinical trial. Participants were randomized to one of three interventions: Mediterranean Diets supplemented with nuts or extra-virgin olive oil, or a control low-fat diet. The present analysis was conducted as an observational prospective cohort study. The median follow-up was 4.8 years. Cardiovascular disease (stroke, myocardial infarction and cardiovascular death) and mortality were ascertained by medical records and National Death Index. Olive oil consumption was evaluated with validated food frequency questionnaires. Multivariate Cox proportional hazards and generalized estimating equations were used to assess the association between baseline and yearly repeated measurements of olive oil intake, cardiovascular disease and mortality. RESULTS During follow-up, 277 cardiovascular events and 323 deaths occurred. Participants in the highest energy-adjusted tertile of baseline total olive oil and extra-virgin olive oil consumption had 35% (HR: 0.65; 95% CI: 0.47 to 0.89) and 39% (HR: 0.61; 95% CI: 0.44 to 0.85) cardiovascular disease risk reduction, respectively, compared to the reference. Higher baseline total olive oil consumption was associated with 48% (HR: 0.52; 95% CI: 0.29 to 0.93) reduced risk of cardiovascular mortality. For each 10 g/d increase in extra-virgin olive oil consumption, cardiovascular disease and mortality risk decreased by 10% and 7%, respectively. No significant associations were found for cancer and all-cause mortality. The associations between cardiovascular events and extra virgin olive oil intake were significant in the Mediterranean diet intervention groups and not in the control group. CONCLUSIONS Olive oil consumption, specifically the extra-virgin variety, is associated with reduced risks of cardiovascular disease and mortality in individuals at high cardiovascular risk. TRIAL REGISTRATION This study was registered at controlled-trials.com (http://www.controlled-trials.com/ISRCTN35739639). International Standard Randomized Controlled Trial Number (ISRCTN): 35739639. Registration date: 5 October 2005.
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Virgin olive oil supplementation and long-term cognition: the PREDIMED-NAVARRA randomized, trial.
Martínez-Lapiscina, EH, Clavero, P, Toledo, E, San Julián, B, Sanchez-Tainta, A, Corella, D, Lamuela-Raventós, RM, Martínez, JA, Martínez-Gonzalez, MÁ
The journal of nutrition, health & aging. 2013;(6):544-52
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OBJECTIVE To assess the effect on cognition of a controlled intervention testing Mediterranean diets (MedDiet). DESIGN Randomized trial after 6.5 years of nutritional intervention. SETTING Eight primary care centers affiliated to the University of Navarra. PARTICIPANTS A random subsample of 285 participants (95 randomly allocated to each of 3 groups) of the PREDIMED-NAVARRA trial. All of them were at high vascular risk (44.8% men, 74.1±5.7 years at cognitive evaluation). INTERVENTIONS Nutritional intervention comparing two MedDiets (supplemented with extra-virgin olive oil [EVOO] or mixed nuts) versus a low-fat control diet. Participants received intensive education to increase adherence to the intended intervention. Participants allocated to the MedDiet groups received EVOO (1 l/week) or 30 g/day of mixed nuts. Dietary habits were evaluated using a validated 137-item food frequency questionnaire (FFQ). Additionally, adherence to MedDiet was appraised using a 14-item questionnaire both at baseline and yearly thereafter. MEASUREMENTS Cognitive performance as a main outcome and cognitive status (normal, mild cognitive impairment [MCI] or dementia) as a secondary outcome were evaluated by two neurologists blinded to group assignment after 6.5 years of nutritional intervention. RESULTS Better post-trial cognitive performance versus control in all cognitive domains and significantly better performance across fluency and memory tasks were observed for participants allocated to the MedDiet+EVOO group. After adjustment for sex, age, education, apolipoprotein E genotype, family history of cognitive impairment/dementia, smoking, physical activity, body mass index, hypertension, dyslipidaemia, diabetes, alcohol and total energy intake, this group also showed lower MCI (OR=0.34 95% CI: 0.12-0.97) compared with control group. Participants assigned to MedDiet+Nuts group did not differ from controls. CONCLUSION A long-term intervention with an EVOO-rich MedDiet resulted in a better cognitive function in comparison with a control diet. However, non-significant differences were found for most cognitive domains. Participants allocated to an EVOO-rich MedDiet had less MCI than controls.
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Five-year trend in hydrogenated vegetable oil consumption among northern Iranian families.
Veghari, G, Sedaghat, M, Maghsodlo, S, Banihashem, S, Moharloei, P, Angizeh, A, Tazik, E, Moghaddami, A
Journal of the American Board of Family Medicine : JABFM. 2013;(6):778-83
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BACKGROUND The main aim of this study was to assess the trends in hydrogenated vegetable oil (HVO) consumption and some related factors among northern Iranian families from 2006 to 2010. METHODS A cross-sectional, population-based study was conducted with 6497 subjects, 15 to 65 years old, who were chosen by multistage cluster random sampling. The subjects were randomly chosen by 325 clusters with an equal size (n = 20 subjects). A multidimensional questionnaire including sociodemographic questions and type of cooking oil used were administered by interviewers. RESULTS The percentages of the sample reporting HVO consumption across the 5 years are as follows: 2006, 85.2%; 2007, 79.7%; 2008, 75.9%; 2009, 59.3%; and 2010, 55.7%. Consumption decreased 29.5% during the 5 years of study and an average of 5.9% per year (P < .05). The estimated odds ratio of HVO consumption in rural areas verus urban areas was 2.59 (95% confidence interval [CI], 2.31-2.90); for poor compared with good economic level the odds ratio was 3.99 (95% CI, 3.13-5.10 for; for the uneducated versus college-educated sample it was 5.75 (95% CI, 4.10-8.17); and the odds ratio was 3.34(95% CI, 2.51-4.45) for Sisstani compared with Fars-native ethnic group. CONCLUSION HVO consumption decreased during the 5-year study (2006 to 2010), but HVO is still used extensively in northern Iran. Preventive early intervention strategies are needed to target uneducated and poor families, with an emphasis on the Sisstanish ethnic group, to increase awareness about the negative consequences of HVO consumption.
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The effect of olive oil polyphenols on antibodies against oxidized LDL. A randomized clinical trial.
Castañer, O, Fitó, M, López-Sabater, MC, Poulsen, HE, Nyyssönen, K, Schröder, H, Salonen, JT, De la Torre-Carbot, K, Zunft, HF, De la Torre, R, et al
Clinical nutrition (Edinburgh, Scotland). 2011;(4):490-3
Abstract
BACKGROUND & AIM: Oxidized LDL (oxLDL) is a highly immunogenic particle that plays a key role in the development of atherosclerosis. Some data suggest a protective role of OxLDL autoantibodies (OLAB) in atherosclerosis. Our aim was to assess the effect of olive oil polyphenols on the immunogenicity of oxLDL to autoantibody generation. METHODS In a crossover, controlled trial, 200 healthy men were randomly assigned to 3-week sequences of 25 mL/day of 3 olive oils with high (366 mg/kg), medium (164 mg/kg), and low (2.7 mg/kg) phenolic content. RESULTS Plasma OLAB concentration was inversely associated with oxLDL (p < 0.001). Olive oil phenolic content increased OLAB generation, with the effect being stronger at higher concentrations of oxLDL (p = 0.020 for interaction). A direct relationship was observed between OLAB and the total olive oil phenol content in LDL (r = 0.209; p = 0.014). OLAB concentrations, adjusted for oxLDL, increased directly in a dose-dependent manner with the polyphenol content of the olive oil administered (p = 0.023). CONCLUSION Olive oil polyphenols promote OLAB generation. This effect is stronger at higher concentrations of lipid oxidative damage.
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A Mediterranean diet rich in virgin olive oil may reverse the effects of the -174G/C IL6 gene variant on 3-year body weight change.
Razquin, C, Martinez, JA, Martinez-Gonzalez, MA, Fernández-Crehuet, J, Santos, JM, Marti, A
Molecular nutrition & food research. 2010;:S75-82
Abstract
Only a few studies have analyzed the effects of the potential interaction between the -174G/C polymorphism of IL6 gene and the adherence to the Mediterranean diet (MD) on adiposity indexes. Our aim was to investigate the interplay between the -174G/C polymorphism of the IL6 gene and a Mediterranean-style diet on body weight changes after 3 years of nutritional intervention in a high cardiovascular risk population. A total of 737 participants, aged 55-80 years were assigned to a low-fat diet or to a Mediterranean-style diet group with high intake of virgin olive oil (VOO) or nuts. Anthropometric measurements were taken at baseline and after 3-year follow-up. The -174G/C polymorphism of the IL6 gene was genotyped. Minor allele frequency (C) was 0.39. At baseline, the CC genotype was associated with higher measures of adiposity. After 3 years, a significant interaction (p=0.028) was found between the polymorphism (GG+GC versus CC) and the nutritional intervention: CC subjects following the MD+VOO had the lowest body weight gain. In conclusion, at baseline, CC subjects for the -174G/C polymorphism of IL6 had the highest body weight and BMI. However, after 3 years of nutritional intervention with MD+VOO, these subjects were predicted to have the greatest reduction in body weight.
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Novel antibacterial and emollient effects of coconut and virgin olive oils in adult atopic dermatitis.
Verallo-Rowell, VM, Dillague, KM, Syah-Tjundawan, BS
Dermatitis : contact, atopic, occupational, drug. 2008;(6):308-15
Abstract
BACKGROUND Atopic dermatitis (AD) skin is dry and readily colonized by Staphylococcus aureus (SA). Coconut and olive oils are traditionally used to moisturize and treat skin infections. OBJECTIVE To compare virgin coconut oil (VCO) and virgin olive oil (VOO) in moisturizing dryness and removing SA from colonized AD skin. METHODS This was a double-blind controlled trial in two outpatient dermatology clinics with adult AD patients who were diagnosed by history, pattern, evolution, and skin lesions and who were randomized to apply VCO or VOO twice daily at two noninfected sites. SA cultures, photography, and objective-SCORAD severity index (O-SSI) scoring were done at baseline and after 4 weeks. RESULTS Twenty-six subjects each received VCO or VOO. Of those on VCO, 20 were positive for SA colonies at baseline versus 12 on VOO. Post intervention, only 1 (5%) VCO subject remained positive versus 6 (50%) of those on VOO. Relative risk for VCO was 0.10, significantly superior to that for VOO (10:1, p = .0028; 95% CI, 0.01-0.73); thus, the number needed to treat was 2.2. For the O-SSI, the difference was not significant at baseline (p = .15) but was significantly different post treatment (p = .004); this was reduced for both oils (p < .005) but was greater with VCO. CONCLUSION VCO and monolaurin's O-SSI reduction and in vitro broad-spectrum activity against SA (given clinical validity here), fungi, and viruses may be useful in the proactive treatment of AD colonization.