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Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial.

ABSTRACT: BACKGROUND:Mechanisms influencing breast cancer (BC) development and recurrence include hyperglycemia, hyperinsulinemia, high insulin-like growth factor-1, high circulating estrogen, inflammation and impaired cellular differentiation/apoptosis. A lifestyle program that targets all the above mechanisms may be warranted. Low glycemic index (GI) foods produce lower post-prandial glucose and insulin responses and have been associated with lower BC risk. Moderate physical activity post-diagnosis reduces BC recurrence and mortality, partly explained by reduced insulin and estrogen levels. Vitamin D increases cell differentiation/apoptosis and high serum vitamin D levels improve BC survival. Yet no trial has evaluated the combined effect of a low GI diet, moderate physical activity and vitamin D supplementation on BC recurrence in the context of a Mediterranean lifestyle setting. METHODS:Women (30-74 yr) who had undergone surgery for primary histologically confirmed BC (stages I-III) within the previous 12 months, in cancer centres in Italy, will be randomized to follow, for a maximum of 33 months, either a high intensity treatment (HIT) composed of low GI diet?+?exercise?+?vitamin D (60 ng/mL serum concentration) or a lower intensity treatment (LITE) with general advice to follow a healthy diet and exercise pattern?+?vitamin D to avoid insufficiency. Both interventions are on a background of a Mediterranean diet. Considering a 20% recurrence rate within 3 years for BC cases and a predicted rate of 10% in the HIT group, with power of 80% and two-sided alpha of 0.05, the subject number required will be 506 (n?=?253 in each arm). Clinic visits will be scheduled every 3 months. Dietary and exercise counselling and vitamin D supplements will be given at each clinic visit when blood samples, anthropometric measures and 7-day food records will be collected. DISCUSSION:DEDiCa study aims to reduce BC recurrence in women with BC using a lifestyle approach with additional vitamin D and to investigate possible cardio-metabolic benefits as well as epigenetic modifications according to lifestyle changes. Given the supporting evidence and safety of the components of our intervention we believe it is feasible and urgent to test it in cancer patients. TRIAL REGISTRATION:May 11, 2016; NCT02786875 . EUDRACT NUMBER:2015-005147-14.

SUBMITTER: Augustin LS

PROVIDER: S-EPMC5259892 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial.

Augustin Livia S A LS Libra Massimo M Crispo Anna A Grimaldi Maria M De Laurentiis Michele M Rinaldo Massimo M D'Aiuto Massimiliano M Catalano Francesca F Banna Giuseppe G Ferrau' Francesco F Rossello Rosalba R Serraino Diego D Bidoli Ettore E Massarut Samuele S Thomas Guglielmo G Gatti Davide D Cavalcanti Ernesta E Pinto Monica M Riccardi Gabriele G Vidgen Edward E Kendall Cyril W C CW Jenkins David J A DJ Ciliberto Gennaro G Montella Maurizio M

BMC cancer 20170123 1

<h4>Background</h4>Mechanisms influencing breast cancer (BC) development and recurrence include hyperglycemia, hyperinsulinemia, high insulin-like growth factor-1, high circulating estrogen, inflammation and impaired cellular differentiation/apoptosis. A lifestyle program that targets all the above mechanisms may be warranted. Low glycemic index (GI) foods produce lower post-prandial glucose and insulin responses and have been associated with lower BC risk. Moderate physical activity post-diagno ...[more]

PMID: 28114909

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Project description:BackgroundLow glycemic index (LGI) diet has shown to be effective in reducing maternal and neonatal complications in high-risk pregnancies.ObjectiveThis trial aimed to examine the effectiveness of individualized LGI diet consultations based on the accurate diet glycemic load (GL) assessment tool on maternal and neonatal insulin resistance levels and diet behavior changes in overweight and obese pregnant women.MethodsOverweight and obese pregnant women were recruited before 16 weeks of gestation and randomized to the LGI diet arm or the control arm. All participants received standard dietary education according to the Chinese Dietary Guide for Pregnant Women. In the intervention arm, additional individualized dietary GL assessments were performed using an app and instructions of lowering diet glycemic index (GI) to achieve LGI diet were provided by a clinical dietitian at early, middle, and late gestation. Primary outcomes were serum insulin at late gestation, incidence of gestational diabetes mellitus (GDM) for mothers, and cord blood C-peptide level of neonates.ResultsIn total, 400 subjects were randomized and received different interventions. There were no significant differences in maternal serum insulin levels (13.2 [9.3-13.2] uU/mL vs 12.4 [10.5-12.4] uU/mL), incidence of GDM (45 [22.5%] vs 43 [21.5%]), or cord blood C-peptide levels (mean 0.9ng/mL [SD 0.7] vs mean 0.8ng/mL [SD 0.6]) in the intervention group compared with the controls. The diet GI at late gestation was similar (mean 63.2 [SD 10.4] vs mean 64.3 [SD 10.4]), whereas greater diet fiber intake was observed in the intervention group (mean 11.6 grams [SD 8.0] vs mean 9.0 grams [SD 5.6]; P=.006). Adherence measurements did not significantly differ between 2 groups.ConclusionsIndividualized LGI diet consultations for overweight and obese pregnant women failed to make a significant difference in maternal or neonatal insulin resistance compared with the standard gestational diet consultation.Trial registrationClinicalTrials.gov NCT01628835; http://clinicaltrials.gov/ct2/show/NCT01628835 (Archived by WebCite at http://www.webcitation.org/77LHgWP0k).

Project description:ImportanceThe ketogenic diet (KD) has been used successfully to treat children with drug-resistant epilepsy. Data assessing the efficacy of the modified Atkins diet (MAD) and low glycemic index therapy (LGIT) diet compared with the KD are scarce.ObjectiveTo determine whether the MAD and LGIT diet are noninferior to the KD among children with drug-resistant epilepsy.Design, setting, and participantsOne hundred seventy children aged between 1 and 15 years who had 4 or more seizures per month, had not responded to 2 or more antiseizure drugs, and had not been treated previously with the KD, MAD, or LGIT diet were enrolled between April 1, 2016, and August 20, 2017, at a tertiary care referral center in India.ExposuresChildren were randomly assigned to receive the KD, MAD, or LGIT diet as additions to ongoing therapy with antiseizure drugs.Main outcomes and measuresPrimary outcome was percentage change in seizure frequency after 24 weeks of dietary therapy in the MAD cohort compared with the KD cohort and in the LGIT diet cohort compared with the KD cohort. The trial was powered to assess noninferiority of the MAD and LGIT diet compared with the KD with a predefined, noninferiority margin of -15 percentage points. Intention-to-treat analysis was used.ResultsOne hundred fifty-eight children completed the trial: KD (n = 52), MAD (n = 52), and LGIT diet (n = 54). Intention-to-treat analysis showed that, after 24 weeks of intervention, the median (interquartile range [IQR]) change in seizure frequency (KD: -66%; IQR, -85% to -38%; MAD: -45%; IQR, -91% to -7%; and LGIT diet: -54%; IQR, -92% to -19%) was similar among the 3 arms (P = .39). The median difference, per intention-to-treat analysis, in seizure reduction between the KD and MAD arms was -21 percentage points (95% CI, -29 to -3 percentage points) and between the KD and LGIT arms was -12 percentage points (95% CI, -21 to 7 percentage points), with both breaching the noninferiority margin of -15 percentage points. Treatment-related adverse events were similar between the KD (31 of 55 [56.4%]) and MAD (33 of 58 [56.9%]) arms but were significantly less in the LGIT diet arm (19 of 57 [33.3%]).Conclusions and relevanceNeither the MAD nor the LGIT diet met the noninferiority criteria. However, the results of this study for the LGIT diet showed a balance between seizure reduction and relatively fewer adverse events compared with the KD and MAD. These potential benefits suggest that the risk-benefit decision with regard to the 3 diet interventions needs to be individualized.Trial registrationClinicalTrials.gov Identifier: NCT02708030.

Dataset Information

Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial.

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Low glycemic index diet, exercise and vitamin D to reduce breast cancer recurrence (DEDiCa): design of a clinical trial.

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