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Safety and tolerability of sustained exogenous ketosis using ketone monoester drinks for 28 days in healthy adults.
Soto-Mota, A, Vansant, H, Evans, RD, Clarke, K
Regulatory toxicology and pharmacology : RTP. 2019;:104506
Abstract
Throughout history, the only way humans could raise their blood ketone levels was by several days of fasting or by following a strict low-carb, high-fat diet. A recently developed, dietary source of ketones, a ketone monoester, elevates d-β-hydroxybutyrate (βHB) to similar concentrations within minutes, with βHB remaining raised for several hours. To date, the longest human safety study of the exogenous ketone ester was for 5 days, but longer consumption times may be desired. Here we report results for 24 healthy adults, aged 18-70 years, who drank 25 ml (26.8 g) of the ketone monoester, (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, three times a day for 28 days (a total of 2.1 L). Anthropomorphic measurements, plus fasting blood and urine analyses were made weekly. It was found that elevating blood βHB concentrations from 0.1 to 4.1 (±1.1) mM three times a day for 28 days had no effect on body weights or composition, fasting blood glucose, cholesterol, triglyceride or electrolyte concentrations, nor blood gases or kidney function, which were invariably normal. Mild nausea was reported following 6 of the 2,016 drinks consumed. We conclude that sustained exogenous ketosis using a ketone monoester is safe and well-tolerated by healthy adults.
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2.
A randomized controlled trial of Mediterranean diet and metformin to prevent age-related diseases in people with metabolic syndrome.
Pasanisi, P, Gargano, G, Gaetana Di Mauro, M, Cortellini, M, Casagrande, A, Villarini, A, Bruno, E, Roveda, E, Saibene, G, Venturelli, E, et al
Tumori. 2018;(2):137-142
Abstract
PURPOSE Age-related non-communicable chronic diseases (ArCDs) are the leading cause of mortality. The major metabolic risk factor for their development is the metabolic syndrome (MetS), defined as a clustering of risk factors of metabolic origin such as abdominal obesity, high blood pressure, dyslipidemia and high fasting glycemia. There is increasing observational and experimental evidence that improving diet and the use of metformin (a calorie-restriction mimetic drug) may modify the risk of developing MetS and ArCD. We designed a phase III randomized controlled trial (the Me.Me.Me trial) to evaluate the effect of a comprehensive lifestyle intervention (including moderate physical activity and a Mediterranean-macrobiotic diet) and the effect of treatment with metformin in the prevention of ArCDs in healthy people with MetS. This report describes the scientific protocol of this trial. METHODS The design of the study is 2 × 2 factorial with 2,000 volunteers to be randomized into 4 equal groups of 500 each, which are allocated to the following treatments: metformin (1,700 mg/day) + active lifestyle intervention, placebo + active lifestyle intervention, metformin (1,700 mg/day) alone, and placebo alone. The metformin/placebo component of the study is double blind. The study is planned for a term of 5 years. RESULTS The Me.Me.Me. trial is ongoing and recruitment of participants is underway. No patient has completed the 5 years of follow-up. CONCLUSIONS We believe that the results of the trial will clarify the importance of lifestyle for primary prevention and the role of metformin as a potential chemopreventive agent. The trial is registred on ClinicalTrials.gov with the identification NCT02960711.
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Providing routine chronic disease preventive care in community substance use services: a pilot study of a multistrategic clinical practice change intervention.
Tremain, D, Freund, M, Wye, P, Bowman, J, Wolfenden, L, Dunlop, A, Bartlem, K, Lecathelinais, C, Wiggers, J
BMJ open. 2018;(8):e020042
Abstract
OBJECTIVES To evaluate the potential effectiveness of a practice change intervention in increasing preventive care provision in community-based substance use treatment services. In addition, client and clinician acceptability of care were examined. DESIGN A pre-post trial conducted from May 2012 to May 2014. SETTING Public community-based substance use treatment services (n=15) in one health district in New South Wales (NSW), Australia. PARTICIPANTS Surveys were completed by 226 clients and 54 clinicians at baseline and 189 clients and 46 clinicians at follow-up. INTERVENTIONS A 12-month multistrategic clinician practice change intervention that aimed to increase the provision of preventive care for smoking, insufficient fruit and/or vegetable consumption and insufficient physical activity. PRIMARY AND SECONDARY OUTCOME MEASURES Client and clinician reported provision of assessment, brief advice and referral for three modifiable health risk behaviours: smoking, insufficient fruit and/or vegetable consumption and insufficient physical activity. Clinician-reported optimal care was defined as providing care to 80% of clients or more. Client acceptability and clinician attitudes towards preventive care were assessed at follow-up. RESULTS Increases in client reported care were observed for insufficient fruit and/or vegetable consumption including: assessment (24% vs 54%, p<0.001), brief advice (26% vs 46%, p<0.001), and clinicians speaking about (10% vs 31%, p<0.001) and arranging a referral (1% vs 8%, p=0.006) to telephone helplines. Clinician reported optimal care delivery increased for: assessment of insufficient fruit and/or vegetable consumption (22% vs 63%, p<0.001) and speaking about telephone helplines for each of the three health risk behaviours. Overall, clients and clinicians held favourable views regarding preventive care. CONCLUSION This study reported increases in preventive care for insufficient fruit and/or vegetable consumption; however, minimal increases were observed for smoking or insufficient physical activity. Further investigation of the barriers to preventive care delivery in community substance use settings is needed. TRIALREGISTRATION NUMBER ACTRN12614000469617.
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Exploring the effectiveness of a comprehensive mind-body intervention for medical symptom relief.
Samuelson, M, Foret, M, Baim, M, Lerner, J, Fricchione, G, Benson, H, Dusek, J, Yeung, A
Journal of alternative and complementary medicine (New York, N.Y.). 2010;(2):187-92
Abstract
OBJECTIVE The objective of this study was to describe possible changes in physical and psychologic symptoms among outpatients completing a 12-week mind-body medical symptom reduction program related to chronic medical conditions. DESIGN The cornerstone of the program is elicitation of the relaxation response, and the curriculum also incorporates trainings on mind-body interactions, cognitive restructuring, nutrition, and physical activity. The Medical Symptom Checklist (MSCL), Health Promoting Lifestyle Profile-II (HPLP-II) and Symptom Checklist-90R (SCL-90-R) were used to assess 331 patients' physical and psychologic symptoms before and after the intervention. RESULTS Significant post-treatment improvements in symptom frequency occurred for 12 individual symptoms on the MSCL, all 6 of the HPLP-II subscales, and 8 of the 9 SCL-90-R subscales from pre- to post-treatment. CONCLUSIONS The results from this uncontrolled study suggest that a comprehensive mind-body intervention program might be useful as a complementary or adjunct therapy for treatment of chronic medical symptoms.
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Is fibre supplementation in paediatric sip feeds beneficial?
Daly, A, Johnson, T, MacDonald, A
Journal of human nutrition and dietetics : the official journal of the British Dietetic Association. 2004;(4):365-70
Abstract
The usefulness of a paediatric fibre containing sip feeds specifically formulated for paediatrics has not been evaluated. In an open, prospective, parallel study the efficacy, safety and tolerance of a paediatric fibre-containing sip feed designed for children weighing 8-20 kg (1-6 years) was compared with a fibre-free sip feed in 60 children with chronic illness. The subjects either received a trial sip feed containing 150 kcal (100 ml)(-1) and 2.0 g (100 ml)(-1) of fibre or a fibre-free equivalent control sip feed for 12 weeks. Blood biochemistry, haematology, anthropometry, tolerance and food intake data were estimated during week 1 and 12. The fibre intake was higher (P < 0.0001) and laxative usage decreased in the fibre-containing sip feed group. The sip feed provided almost 50% of fibre intake in the trial group. There were no differences in sip feed tolerance, anthropometry, nutritional biochemistry or haematology between the two groups. Sip feeds provide an important source of fibre for sick children with normal gut function requiring nutritional support.
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Clinical efficacy and safety of fluticasone propionate 1 mg twice daily administered via a HFA 134a pressurized metered dose inhaler to patients with severe asthma. U.K. study group.
Ayres, JG, Millar, AB, Sykes, AP
Respiratory medicine. 2000;:S42-50
Abstract
A randomized, double-blind, cross-over study was conducted to assess the efficacy and safety of fluticasone propionate 1 mg twice daily administered via a pressurized metered dose inhaler (pMDI) containing the new non-chlorofluorocarbon (CFC) propellant (HFA 134a), or the established CFC propellants 11 and 12 in patients with severe asthma. The study comprised a 2-week run-in period followed by two 6-week treatment periods, with no washout period in between. One hundred and nineteen symptomatic adult patients with severe asthma, who were receiving inhaled beclomethasone 2-4 mg day(-1) or equivalent, were randomized to treatment. Patients were randomized to one of two sequence groups (sequence 1: HFA 134a pMDI then CFC pMDI or sequence 2: CFC pMDI then HFA 134a pMDI). The sequence groups differed with respect to mean peak expiratory flow (PEF) at baseline; however, the magnitude of the increase in PEF from baseline during treatment was similar in the two sequence groups. Mean PEF at baseline was 334 l min(-1) in sequence group 1 (HFA 134a-->CFC pMDI) and this increased to 357 l min(-1) and 366 l min(-1) during treatment with the HFA 134a and CFC pMDI, respectively. In sequence group 2 (CFC-->HFA 134a pMDI) mean PEF at baseline was 297 l min(-1) and this increased to 336 l min(-1) and 328 l min(-1) during treatment with the HFA 134a and CFC pMDI, respectively. Based on an overall analysis of the two treatment groups at week 6, equivalence was demonstrated; the mean treatment difference (HFA 134a-CFC pMDI) in morning PEF was 0 l min(-1) (90% confidence interval (CI), for difference between groups: -7, 6 l min(-1)). There was a comparable improvement in secondary efficacy variables, including clinic lung function measurements, in the two treatment groups. The incidence and type of most adverse events were similar in the two treatment groups. There was no difference in the adjusted geometric mean morning serum cortisol levels after treatment with the HFA 134a and CFC pMDI. Therefore, the fluticasone propionate HFA 134a pMDI constitutes a suitable replacement for the established CFC pMDI at a microgram equivalent dose.