Purpose Fatigue is a prevalent and burdensome effect of breast cancer. Fatigue has been linked to chronic inflammation, and diets high in antioxidant nutrients have been associated with lesser prevalence and severity of fatigue. Studies are needed, however, to test if antioxidant-rich diets could improve fatigue. Methods Pilot, randomized, trial conducted between January 2014 and April 2015, to investigate if a 3-month diet rich in fruit, vegetables, whole grains, and omega-3 fatty acid-rich foods, named the fatigue reduction diet (FRD), improved fatigue and sleep compared to an attention control, named the general health curriculum (GHC). 30 stage 0 to III breast cancer survivors, who had completed cancer treatments, were randomized: 15 receiving the FRD and 15 the GHC. Primary outcome was change in fatigue, as measured by the brief fatigue Inventory, from baseline to 3 months analyzed using linear mixed models. Secondary analyses were changes in sleep quality, serum carotenoids, and fatty acids. Results From baseline to 3-month fatigue improved by 44 ± 39% in FRD compared to 8 ± 34% in GHC (p = 0.01); sleep quality improved by 2.5 ± 3.3 points in FRD, and diminished by 0.9 ± 2.3 in GHC (p = 0.03); serum total carotenoids (p < 0.01), β-cryptoxanthin (p = 0.02), lutein (p = 0.05), zeaxanthin (p = 0.01), lycopene (p = 0.05), omega-3 fatty acids (p < 0.01), and ratio of omega-3:omega-6 fatty acids (p = 0.02) were significantly increased, and percent saturated fatty acids were decreased (p = 0.04) in FRD; γ-tocopherol was significantly increased in GHC (p = 0.03), and there was a significant visit by group difference for α-carotene between the study groups (p = 0.05). Conclusions The FRD intervention improved fatigue and sleep in breast cancer survivors compared to the GHC. FRD diet could provide a non-toxic treatment strategy for persistent fatigue.

Background: In patients with heart failure (HF), malnutrition and dietary sodium excess are common and may worsen outcomes. No prior studies have provided low-sodium, nutritionally-complete meals following HF hospitalization. Methods and Results: The Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure (GOURMET-HF) study randomized patients discharged from HF hospitalization to four weeks of home-delivered sodium-restricted Dietary Approaches to Stop Hypertension meals (DASH/SRD; 1,500 mg sodium/day) vs. usual care. The primary outcome was the between-group change in the Kansas City Cardiomyopathy Questionnaire (KCCQ) Summary Score from discharge to four weeks post-discharge. Additional outcomes included changes in the KCCQ Clinical Summary Score and cardiac biomarkers. All patients were followed 12 weeks for death/all-cause readmission and potential diet-related adverse events (symptomatic hypotension, hyperkalemia, acute kidney injury). 66 patients were randomized 1:1 at discharge to DASH/SRD vs. usual care (age 71±8 years, 30% female, ejection fraction 39±18%). The KCCQ Summary Score increased similarly between groups (DASH/SRD 46±23 to 59±20 vs. usual care 43±19 to 53±24, p=0.38) but the KCCQ Clinical Summary Score increase tended to be greater in DASH/SRD participants (47±22 to 65±19 vs. 45±20 to 55±26, p=0.053). Potentially diet-related adverse events were uncommon; 30-day HF readmissions (11% vs. 27%, p=0.06) and days rehospitalized within that timeframe (17 vs. 55, p=0.055) trended lower in DASH/SRD participants. Conclusions: Home-delivered DASH/SRD following HF hospitalization appeared safe in selected patients, and had directionally favorable effects on HF clinical status and 30-day readmissions. Larger studies are warranted to clarify the effects of post-discharge nutritional support in patients with HF. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02148679

Background High dietary sodium intake is a significant public health problem in the United States. High sodium consumption is associated with high blood pressure and high risk of cardiovascular disease. Objective The aim of this study was to evaluate the effect of a just-in-time adaptive mobile app intervention, namely, LowSalt4Life, on reducing sodium intake in adults with hypertension. Methods In this study, 50 participants aged ≥18 years who were under treatment for hypertension were randomized (1:1, stratified by gender) into 2 groups, namely, the App group (LowSalt4Life intervention) and the No App group (usual dietary advice) in a single-center, prospective, open-label randomized controlled trial for 8 weeks. The primary endpoint was the change in the 24-hour urinary sodium excretion estimated from spot urine by using the Kawasaki equation, which was analyzed using unpaired two-sided t tests. Secondary outcomes included the change in the sodium intake measured by the food frequency questionnaire (FFQ), the 24-hour urinary sodium excretion, blood pressure levels, and the self-reported confidence in following a low-sodium diet. Results From baseline to week 8, there was a significant reduction in the Kawasaki-estimated 24-hour urinary sodium excretion calculated from spot urine in the App group compared to that in the No App group (–462 [SD 1220] mg vs 381 [SD 1460] mg, respectively; P=.03). The change in the 24-hour urinary sodium excretion was –637 (SD 1524) mg in the App group and –322 (SD 1485) mg in the No App group (P=.47). The changes in the estimated sodium intake as measured by 24-hour dietary recall and by FFQ in the App group were –1537 (SD 2693) mg and –1553 (SD 1764) mg while those in the No App group were –233 (SD 2150) mg and –515 (SD 1081) mg, respectively (P=.07 and P=.01, respectively). The systolic blood pressure change from baseline to week 8 in the App group was –7.5 mmHg while that in the No App group was –0.7 mmHg (P=.12), but the self-confidence in following a low-sodium diet was not significantly different between the 2 groups. Conclusions This study shows that a contextual just-in-time mobile app intervention resulted in a greater reduction in the dietary sodium intake in adults with hypertension than that in the control group over a 8-week period, as measured by the estimated 24-hour urinary sodium excretion from spot urine and FFQ. The intervention group did not show a significant difference from the control group in the self-confidence in following a low sodium diet and in the 24-hour urinary sodium excretion or dietary intake of sodium as measured by the 24-hour dietary recall. A larger clinical trial is warranted to further elucidate the effects of the LowSalt4Life intervention on sodium intake and blood pressure levels in adults with hypertension. Trial Registration ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 International Registered Report Identifier (IRRID) RR2-10.2196/11282

Background There has been little research published on the adaptation of diabetic exchange list diet approaches for the design of intervention diets in health research despite their clinical utility. The exchange list approach can provide clear and precise guidance on multiple dietary changes simultaneously. The objective of this study was to develop exchange list diets for Mediterranean and Healthy Eating, and to evaluate adherence, dietary intakes and markers of health risks with each counselling approach in 120 subjects at increased risk for developing colon cancer. Methodology A randomized clinical trial was implemented in the USA involving telephone counselling. The Mediterranean diet had ten dietary goals targeting increases in monounsaturated fats, n3 fats, whole grains and the amount and variety of fruits and vegetables. The Healthy Eating diet had five dietary goals that were based on the U.S. Healthy People 2010 recommendations. Results Dietary compliance was similar in both diet arms with 82–88% of goals being met at 6 months, but subjects took more time to achieve the Mediterranean goals than the Healthy Eating goals. The relatively modest fruit and vegetable goals in the Healthy Eating arm were exceeded, resulting in fruit and vegetable intakes of about 8 servings/day in each arm after six months. A significant (P<0.05) weight loss and a decrease in serum C-reactive protein concentrations were observed in the overweight/obese subgroup of subjects in the Mediterranean arm in the absence of weight loss goals. Conclusions Counselling for the Mediterranean diet may be useful for both improving diet quality and for achieving a modest weight loss in overweight or obese individuals.

Little is known about dietary effect on colonic nutrient concentrations associated with preventive foods. This study observed 120 persons at increased risk of colon cancer randomized to a Mediterranean versus a Healthy Eating diet for six months. The former targeted increases in whole grains, fruits, vegetables, monounsaturated and n3 fats. Healthy Eating diet was based on Healthy People 2010 recommendations. At baseline, dietary fat and carotenoid intakes were poorly associated (Spearman ρ < 0.4) with serum and colon concentrations. Strong associations were observed between serum and colon measurements of β-cryptoxanthin (ρ = 0.58, p-value < 0.001), α-carotene (ρ = 0.48, p-value < 0.001), and β-carotene (ρ = 0.45, p-value < 0.001). After six months, the Healthy Eating arm increased serum lutein, β- and α-carotene significantly (p-value < 0.05). In the Mediterranean arm the significant increases were in serum lutein, β-cryptoxanthin, β-carotene, monounsaturated and n3 fats. A significant group-by-time interaction (p-value = 0.03) was obtained for monounsaturated fats. Colonic increases in carotenoids and n3 fats were significant only in Healthy Eating arm, while group-by-time interaction were significant for β-carotene (p-value = 0.02), and α-carotene (p-value = 0.03). Changes in colon concentrations were not significantly associated with reported dietary changes. Changes in colon and serum concentrations were strongly associated for β-cryptoxanthin (ρ = 0.56, p-value < 0.001), and α-carotene (ρ = 0.40, p-value < 0.001). The associations between colonic and serum concentrations suggest the potential utility of using serum concentration as a target in dietary interventions aimed at reducing colon cancer risk.

This study recruited persons at increased risk of colon cancer to an intensive dietary intervention study that required biopsies of the colon by flexible sigmoidoscopy at baseline and after six months of intervention. A total of 1314 individuals contacted the study, and only 16 individuals indicated that the sigmoidoscopy procedure was an obstacle to study participation. A total of 270 individuals completed a screening visit and signed a screening consent form. Inquiries about the study tended to be fewer in the winter and late summer. Failure to return food records was the most common reason for exclusion. Dietary recall at enrollment indicated that subjects were consuming significantly more vegetables, lower sodium and a lower glycemic load on the day before starting the study versus during the eligibility phase which might have an impact on biomarker measures. This makes it important to capture dietary changes in the period between determination of eligibility and enrollment. Subjects (n=120) were randomized to follow a Healthy Eating or a Mediterranean Diet, each of which required substantial dietary record-keeping. The study completion rate was 78%, and subjects reported high satisfaction with study participation. Of the 93 individuals who completed the study, only one refused the flexible sigmoidoscopy at the final visit. These findings suggest that flexible sigmoidoscopy does not appear to be a barrier for recruitment of high-risk individuals to an intensive dietary intervention trial, but that completing food records can be.

No abstract

No abstract