scholarly journals Randomised controlled trial of intermittent vs continuous energy restriction during chemotherapy for early breast cancer

2021 ◽  
Author(s):  
Michelle Harvie ◽  
Mary Pegington ◽  
Sacha J. Howell ◽  
Nigel Bundred ◽  
Phil Foden ◽  
...  
Keyword(s):  
Body Fat ◽  
Weight Control ◽  
Controlled Trial ◽  
Energy Restriction ◽  
Clinical Trial Registration ◽  
Chemotherapy Toxicity ◽  
Continuous Energy ◽  
Potential Efficacy ◽  
Grade 3 ◽  
Randomised Controlled

Abstract Background Excess adiposity at diagnosis and weight gain during chemotherapy is associated with tumour recurrence and chemotherapy toxicity. We assessed the efficacy of intermittent energy restriction (IER) vs continuous energy restriction (CER) for weight control and toxicity reduction during chemotherapy. Methods One hundred and seventy-two women were randomised to follow IER or CER throughout adjuvant/neoadjuvant chemotherapy. Primary endpoints were weight and body fat change. Secondary endpoints included chemotherapy toxicity, cardiovascular risk markers, and correlative markers of metabolism, inflammation and oxidative stress. Results Primary analyses showed non-significant reductions in weight (−1.1 (−2.4 to +0.2) kg, p = 0.11) and body fat (−1.0 (−2.1 to +0.1) kg, p = 0.086) in IER compared with CER. Predefined secondary analyses adjusted for body water showed significantly greater reductions in weight (−1.4 (−2.5 to −0.2) kg, p = 0.024) and body fat (−1.1 (−2.1 to −0.2) kg, p = 0.046) in IER compared with CER. Incidence of grade 3/4 toxicities were comparable overall (IER 31.0 vs CER 36.5%, p = 0.45) with a trend to fewer grade 3/4 toxicities with IER (18%) vs CER (31%) during cycles 4–6 of primarily taxane therapy (p = 0.063). Conclusions IER is feasible during chemotherapy. The potential efficacy for weight control and reducing toxicity needs to be tested in future larger trials. Clinical trial registration ISRCTN04156504.

scholarly journals Contrary to the Conclusions Stated in the Paper, Only Dry Fat-Free Mass Was Different between Groups upon Reanalysis. Comment on: “Intermittent Energy Restriction Attenuates the Loss of Fat-Free Mass in Resistance Trained Individuals. A Randomized Controlled Trial”

2020 ◽  
Vol 5 (4) ◽  
pp. 85
Author(s):  
Jackson Peos ◽  
Andrew W. Brown ◽  
Colby J. Vorland ◽  
David B. Allison ◽  
Amanda Sainsbury
Keyword(s):  
Randomized Controlled Trial ◽  
Body Composition ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Resting Metabolic Rate ◽  
Energy Restriction ◽  
Fat Free Mass ◽  
Randomized Controlled ◽  
Continuous Energy ◽  
Randomised Controlled

Campbell and colleagues recently published a randomised controlled trial investigating the effects of diets involving intermittent energy restriction versus continuous energy restriction on changes in body composition and resting metabolic rate (RMR) in resistance-trained adults[...]

scholarly journals Continuous versus intermittent moderate energy restriction for increased fat mass loss and fat free mass retention in adult athletes: protocol for a randomised controlled trial—the ICECAP trial (Intermittent versus Continuous Energy restriction Compared in an Athlete Population)

2018 ◽  
Vol 4 (1) ◽  
pp. e000423 ◽  
Author(s):  
Jackson J Peos ◽  
Eric R Helms ◽  
Paul A Fournier ◽  
Amanda Sainsbury
Keyword(s):  
Randomised Controlled Trial ◽  
Fat Mass ◽  
Controlled Trial ◽  
Resting Energy Expenditure ◽  
Energy Restriction ◽  
Fat Free Mass ◽  
Muscle Performance ◽  
Adaptive Responses ◽  
Continuous Energy ◽  
Randomised Controlled

IntroductionReducing fat mass (FM) while retaining fat free mass (FFM) is a common goal of athletes. Evidence suggests that some—but not all—forms of intermittent energy restriction (IER) may be superior to the conventional method of continuous energy restriction (CER) for people with excess body fat that are sedentary, by reducing some of the adaptive responses to ER. However, it is yet to be established whether this dietary approach is effective for athletes.Methods and analysisA single-blind, parallel group, randomised controlled trial with a 1:1 allocation ratio is proposed. Sixty healthy athletes aged ≥18 years will be recruited from local sporting facilities and randomised to an intervention of either moderate CER (mCER) or moderate IER (mIER). Both interventions will consist of 12 weeks of moderate ER, plus 3 weeks in energy balance (EB). The mCER intervention will entail 12 weeks of continuous moderate ER, followed by 3 weeks in EB. The mIER intervention will entail 12 weeks of moderate ER, administered as 4×3 week blocks of moderate ER, interspersed with 3×1 week blocks of EB. The co-primary outcomes are changes in FM and FFM after 12 weeks of moderate ER. Secondary outcomes will be changes in FM and FFM at 15 weeks after intervention commencement, as well as muscle performance, physical activity, sleep quality, changes in resting energy expenditure, subjective drive to eat, circulating concentrations of appetite-regulating hormones, mood states and diet acceptability.Trial registrationACTRN12618000638235p.

scholarly journals Correction to: The effect of moderate intermittent versus continuous energy restriction on body composition and resting metabolic rate in resistance-trained females: A randomized controlled trial

2020 ◽  
Vol 17 (1) ◽  
Author(s):  
Madelin R. Siedler ◽  
Eric T. Trexler ◽  
Megan N. Humphries ◽  
Priscila Lamadrid ◽  
Brian Waddell ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Body Composition ◽  
Metabolic Rate ◽  
Controlled Trial ◽  
Resting Metabolic Rate ◽  
Energy Restriction ◽  
Randomized Controlled ◽  
Continuous Energy

An amendment to this paper has been published and can be accessed via the original article.

Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial

Perfusion ◽  
2017 ◽  
Vol 32 (7) ◽  
pp. 591-597 ◽  
Author(s):  
Geoff G. Lockwood ◽  
Leilani Cabreros ◽  
Dorota Banach ◽  
Prakash P. Punjabi
Keyword(s):  
Cardiac Surgery ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Subcutaneous Infusion ◽  
Randomised Controlled Study ◽  
Randomised Controlled

Background: Continuous bilateral thoracic paravertebral blockade has been used for analgesia after cardiac surgery, but its efficacy has never been formally tested. Method: Fifty adult patients were enrolled in a double-blind, randomised, controlled study of continuous bilateral thoracic paravertebral infusion of 0.5% lidocaine (1 mg.kg-1.hr-1) for analgesia after coronary surgery. Control patients received a subcutaneous infusion of lidocaine at the same rate through catheters inserted at the same locations as the study group. The primary outcome was morphine consumption at 48 hours using patient-controlled analgesia (PCA). Secondary outcomes included pain, respiratory function, nausea and vomiting. Serum lidocaine concentrations were measured on the first two post-operative days. Results: There was no difference in morphine consumption or in any other outcome measure between the groups. Serum lidocaine concentrations increased during the study, with a maximum of 5.9 mg.l-1. There were no adverse events as a consequence of the study. Conclusion: Bilateral paravertebral infusion of lidocaine confers no advantage over systemic lidocaine infusion after cardiac surgery. Clinical trial registration: ISRCTN13424423 ( https://www.isrctn.com )

Plasma Nesfatin-1 Level in Obese Patients after Acupuncture: A Randomised Controlled Trial

2014 ◽  
Vol 32 (4) ◽  
pp. 313-317 ◽  
Author(s):  
Yongfang Guo ◽  
Mingqing Xing ◽  
Wenjuan Sun ◽  
Xiaoyan Yuan ◽  
Hongyan Dai ◽  
...  
Keyword(s):  
Weight Control ◽  
Serum Insulin ◽  
Controlled Trial ◽  
Diet Group ◽  
Normal Weight ◽  
Obese Patients ◽  
Obese Adults ◽  
The Difference ◽  
Randomised Controlled ◽  
The Relationship

Background Nesfatin-1 is an anorexigenic hormone suggested to regulate obesity. Objective To investigate the relationship between nesfatin-1 level and anthropometric and metabolic parameters in obese patients, and examine the change in plasma nesfatin-1 level after acupuncture treatment. Methods 64 obese adult patients without diabetes and 58 normal weight control subjects were enrolled in this study. The obese patients were randomly divided into an acupuncture plus diet group (n=32) and a diet only group (n=32). Measurements were repeated after 45 days. Results Body mass index (BMI), waist and hip circumferences, serum insulin, lipoprotein and insulin resistance measures were significantly higher, and plasma nesfatin-1 level was significantly lower, in obese patients than in normal weight controls. In addition, negative correlations were found between plasma nesfatin-1 level and BMI, waist and hip circumferences. Weight reduction in participants after acupuncture and diet restriction was 7.0% and 4.3%, respectively. Plasma nesfatin-1 level increased from 2.75±1.16 to 3.44±1.28 ng/mL and from 2.86±1.07 to 3.23±1.06 ng/mL in acupuncture and diet groups, respectively; the difference was significant, p<0.05. Conclusions Plasma nesfatin-1 level is reduced in obese adults, and is increased after acupuncture. The beneficial effect of acupuncture on obesity is associated with increased plasma nesfatin-1 level.

scholarly journals Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial

2019 ◽  
Vol 25 (3) ◽  
pp. 305-309 ◽  
Author(s):  
Robert Fahed ◽  
Tim E Darsaut ◽  
Charbel Mounayer ◽  
René Chapot ◽  
Michel Piotin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Arteriovenous Malformation ◽  
Arteriovenous Malformations ◽  
Controlled Trial ◽  
Controlled Clinical Trial ◽  
Cerebral Arteriovenous Malformations ◽  
Clinical Trial Registration ◽  
Transarterial Embolisation ◽  
Randomised Controlled ◽  
Transvenous Approach

Background Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation. Methods The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored. Discussion The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.

scholarly journals Study protocol for a 9-month randomised controlled trial assessing the effects of almonds versus carbohydrate-rich snack foods on weight loss and weight maintenance

BMJ Open ◽  
2020 ◽  
Vol 10 (7) ◽  
pp. e036542
Author(s):  
Sharayah Carter ◽  
Alison M Hill ◽  
Catherine Yandell ◽  
Jonathan D Buckley ◽  
Sze-Yen Tan ◽  
...  
Keyword(s):  
Weight Loss ◽  
Clinical Trials ◽  
Randomised Controlled Trial ◽  
Energy Expenditure ◽  
Controlled Trial ◽  
Weight Maintenance ◽  
Energy Restriction ◽  
Cardiometabolic Health ◽  
Snack Foods ◽  
Randomised Controlled

IntroductionEpidemiological studies indicate an inverse association between nut consumption and body mass index (BMI). However, clinical trials evaluating the effects of nut consumption compared with a nut-free diet on adiposity have reported mixed findings with some studies reporting greater weight loss and others reporting no weight change. This paper describes the rationale and detailed protocol for a randomised controlled trial assessing whether the inclusion of almonds or carbohydrate-rich snacks in an otherwise nut-free energy-restricted diet will promote weight loss during 3 months of energy restriction and limit weight regain during 6 months of weight maintenance.Methods and analysisOne hundred and thirty-four adults aged 25–65 years with a BMI of 27.5–34.9 kg/m2 will be recruited and randomly allocated to either the almond-enriched diet (AED) (15% energy from almonds) or a nut-free control diet (NFD) (15% energy from carbohydrate-rich snack foods). Study snack foods will be provided. Weight loss will be achieved through a 30% energy restriction over 3 months, and weight maintenance will be encouraged for 6 months by increasing overall energy intake by ~120–180 kcal/day (~500-750kJ/day) as required. Food will be self-selected, based on recommendations from the study dietitian. Body composition, resting energy expenditure, total daily energy expenditure (via doubly labelled water), physical activity, appetite regulation, cardiometabolic health, gut microbiome, liver health, inflammatory factors, eating behaviours, mood and personality, functional mobility and pain, quality of life and sleep patterns will be measured throughout the 9-month trial. The effects of intervention on the outcome measures over time will be analysed using random effects mixed models, with treatment (AED or NFD) and time (baseline, 3 months and 9 months) being the between and within factors, respectively in the analysis.Ethics and disseminationEthics approval was obtained from the University of South Australia Human Research Ethics Committee (201436). Results from this trial will be disseminated through publication in peer-reviewed journals, national and international presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001861246).

scholarly journals Intermittent Energy Restriction Attenuates the Loss of Fat Free Mass in Resistance Trained Individuals. A Randomized Controlled Trial

2020 ◽  
Vol 5 (1) ◽  
pp. 19 ◽  
Author(s):  
Bill I. Campbell ◽  
Danielle Aguilar ◽  
Lauren M. Colenso-Semple ◽  
Kevin Hartke ◽  
Abby R. Fleming ◽  
...  
Keyword(s):  
Caloric Restriction ◽  
Controlled Trial ◽  
Resting Metabolic Rate ◽  
Energy Restriction ◽  
Fat Free Mass ◽  
Continuous Group ◽  
Continuous Energy ◽  
Group A ◽  
Males And Females ◽  
Composition Changes

There is a lack of research into how lean, resistance trained (RT) individuals respond to intermittent energy restricted diets. Therefore, we investigated body composition changes in RT-individuals during continuous energy restriction or intermittent restriction. A total of 27 males and females (25 ± 6.1 years; 169 ± 9.4 cm; 80 ± 15.6 kg) were randomized to a ~25% caloric restricted diet Refeed (RF; n = 13) or Continuous group (CN; n = 14) in conjunction with 4-days/week resistance training for 7-weeks. RF implemented two consecutive days of elevated carbohydrate (CHO) intake, followed by 5-days of caloric restriction each week. CN adhered to a continuous 7-week caloric restriction. Body mass (BM), fat mass (FM), fat-free mass (FFM), dry fat-free mass (dFFM), and resting metabolic rate (RMR) were assessed pre/post-diet. Both groups significantly reduced BM (RF: baseline = 76.4 ± 15.6 kg, post-diet = 73.2 ± 13.8 kg, Δ3.2 kg; CN: baseline = 83.1 ± 15.4 kg, post-diet = 79.5 ± 15 kg, Δ3.6 kg) and FM (RF: baseline = 16.3 ± 4 kg, post-diet = 13.5 ± 3.6 kg, Δ2.8 kg; CN: baseline = 16.7 ± 4.5 kg, post-diet = 14.4 ± 4.9 kg, Δ2.3 kg) with no differences between groups. FFM (RF: baseline = 60.1 ± 13.8 kg, post-diet = 59.7 ± 13.0 kg, 0.4 kg; CN: baseline = 66.4 ± 15.2 kg, post-diet = 65.1 ± 15.2 kg, Δ1.3 kg p = 0.006), dFFM (RF: baseline = 18.7 ± 5.0 kg, post-diet = 18.5 ± 4.5 kg, Δ0.2 kg; CN: baseline =21.9 ± 5.7 kg, post-diet = 20.0 ± 5.7 kg, Δ1.9 kg), and RMR (RF: baseline = 1703 ± 294, post-diet = 1665 ± 270, Δ38 kcals; CN: baseline = 1867 ± 342, post-diet = 1789 ± 409, Δ78 kcals) were better maintained in the RF group. A 2-day carbohydrate refeed preserves FFM, dryFFM, and RMR during energy restriction compared to continuous energy restriction in RT-individuals.

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