Abstract 13582: The Effect of Time-restricted Feeding on Weight: A Randomized Feeding Trial

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Nisa Maruthur ◽  
Scott Pilla ◽  
May T Maw ◽  
Daisy Duan ◽  
Di Zhao ◽  
...  

Introduction: Time-restricted feeding (TRF) may improve cardiometabolic outcomes. Prior studies of TRF in humans were limited by lack of randomization and controlled feeding, inadequate sample size and short duration. Hypothesis: Participants following a TRF pattern will lose more weight at 12 weeks than those following a Usual Feeding Pattern (UFP). Methods: We randomized 41 adults with BMI 30-49.9 kg/m 2 and HbA1c 5.7-6.9% to either TRF (80% of total calories before 1 pm) or a UFP (50% of calories after 5 pm) for 12 weeks. Dietary caloric requirement for weight maintenance was determined at baseline for each participant and held constant during the intervention. Participants in both arms consumed the same diet with the same nutrient and food content and only consumed food prepared by the study metabolic kitchen. The primary outcome was weight. Weight and office blood pressure were measured at baseline and 4, 8, and 12 weeks and were analyzed using a linear mixed effects model with an unstructured covariance with indicators for visit and intervention interacted with visit. Results: All participants completed the study (TRF, n=21; UFP, n=20). Demographics were similar across arms; mean age was 59 years, and over 90% of participants were female and were black. Baseline weight and systolic BP were higher in the UFP than TRF arm (Table). Weight and blood pressure decreased in both arms during the study, but these decreases did not differ by arm. Conclusions: In this controlled feeding study, TRF did not reduce weight and blood pressure compared to UFP.

Nutrients ◽  
2021 ◽  
Vol 13 (8) ◽  
pp. 2678
Author(s):  
Sharon Turban ◽  
Stephen P. Juraschek ◽  
Edgar R. Miller ◽  
Cheryl A. M. Anderson ◽  
Karen White ◽  
...  

In the general population, an increased potassium (K) intake lowers blood pressure (BP). The effects of K have not been well-studied in individuals with chronic kidney disease (CKD). This randomized feeding trial with a 2-period crossover design compared the effects of diets containing 100 and 40 mmol K/day on BP in 29 adults with stage 3 CKD and treated or untreated systolic BP (SBP) 120–159 mmHg and diastolic BP (DBP) <100 mmHg. The primary outcome was 24 hour ambulatory systolic BP. The higher- versus lower-K diet had no significant effect on 24 hour SBP (−2.12 mm Hg; p = 0.16) and DBP (−0.70 mm Hg; p = 0.44). Corresponding differences in clinic BP were −4.21 mm Hg for SBP (p = 0.054) and −0.08 mm Hg for DBP (p = 0.94). On the higher-K diet, mean serum K increased by 0.21 mmol/L (p = 0.003) compared to the lower-K diet; two participants had confirmed hyperkalemia (serum K ≥ 5.5 mmol/L). In conclusion, a higher dietary intake of K did not lower 24 hour SBP, while clinic SBP reduction was of borderline statistical significance. Additional trials are warranted to understand the health effects of increased K intake in individuals with CKD.


Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Ruth-Alma N Turkson-Ocran ◽  
Edgar R Miller ◽  
Di Zhao ◽  
Scott Pilla ◽  
Daisy Duan ◽  
...  

Introduction: Some studies suggest that time-restricted feeding may decrease blood pressure (BP), but the current evidence is inconclusive. Objective: To determine the effect of a time-restricted feeding pattern compared to a usual feeding pattern on ambulatory 24-hour BP in adults. Hypothesis: An isocaloric, time-restricted feeding pattern will lower 24-hour BP more than an isocaloric usual feeding pattern over 12 weeks. Methods: Forty-one persons with prediabetes (HbA1c 5.7-6.9%) and obesity (BMI 30-50 kg/m 2 ) were randomized to consume 80% of their total calories before 1 pm (i.e., time-restricted feeding) or more than 50% of their calories after 5 pm (i.e., usual feeding) with identical macronutrient content. We used ambulatory BP monitoring to measure BP over 24-hours at baseline and 12-weeks. Outcomes of interest were mean systolic and diastolic 24-hr, daytime (7 am - 11 pm), and nighttime (11 pm - 7 am) BP. To examine the difference in BP patterns between time-restricted feeding and usual feeding pattern groups in change in BP outcomes from baseline to 12 weeks, we used linear mixed-effects regression models with participant-specific random intercepts and fixed effects for visit and intervention group. To assess whether feeding patterns affected BP levels over the 12 week intervention period, we tested whether there was an intervention-by-time interaction. Results: Thirty-five adults (mean age 60.4 years; 91% female, 91% African American) had sufficient data. We found reductions from baseline in systolic and diastolic BP for both groups for the 24-hour, daytime, and nighttime periods. The decrease in BP was larger in the usual feeding pattern group compared to the time-restricted feeding group (Table). Conclusion: Time-restricted feeding may attenuate the effect of a healthy isocaloric diet on BP compared to typical feeding patterns, and at this time, should not be recommended as a way to lower BP more than simply adopting a healthy diet.


Nutrients ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 186
Author(s):  
Carlett Ramirez-Farias ◽  
Geraldine E. Baggs ◽  
Barbara J. Marriage

Background: The purpose of this study was to evaluate the growth, tolerance and compliance effects of an extensively hydrolyzed formula with added 2′-FL in an intended use population of infants. Methods: A non-randomized, single-group, multicenter study was conducted. Infants (0–60 days of age) with suspected food protein allergy, persistent feeding intolerance, or presenting conditions where an extensively hydrolyzed formula (eHF) was deemed appropriate were enrolled in a 2-month feeding trial. The primary outcome was maintenance of weight for age z-score during the study. Weight, length, head circumference, formula intake, tolerance measures, clinical symptoms and questionnaires were collected. Forty-eight infants were enrolled and 36 completed the study. Results: Weight for age z-scores of infants showed a statistically significant improvement from study day 1 to study day 60 (0.32 ± 0.11, p = 0.0078). Conclusions: Overall, the results of the study demonstrate that the study formula was well tolerated, safe and supported growth in the intended population.


Author(s):  
Young Su Joo ◽  
Hyung Woo Kim ◽  
Ki Heon Nam ◽  
Jee Young Lee ◽  
Tae Ik Chang ◽  
...  

Studies on the longitudinal temporal trend of blood pressure (BP) and its impact on kidney function are scarce. Here, we evaluated the association of dynamic changes in systolic blood pressure (SBP) over time with adverse kidney outcomes. We analyzed 1837 participants from the KNOW-CKD (Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease). The main exposure was 3 distinct SBP trajectories determined by the latent class mixed model (decreasing, stable, and increasing) using 3 SBP measurements at 0, 6, and 12 months. The primary outcome was CKD progression, defined as a composite of halving estimated glomerular filtration rate from baseline value or onset of end-stage kidney disease. SBP declined from 144 to 120 mm Hg in the decreasing SBP trajectory group and rose from 114 to 136 mm Hg in the increasing trajectory group within 1 year. During 6576 person-years of follow-up (median, 3.7 years), the composite outcome occurred in 521 (28.4%) participants. There were fewer primary outcome events in the decreasing (30.6%) and stable (26.5%) SBP trajectory groups than in the increasing trajectory group (33.0%). In the multivariable-adjusted cause-specific hazards model, increasing SBP trajectory was associated with a 1.28-fold higher risk for adverse kidney outcome compared with stable SBP trajectory. However, the risk for the primary outcome did not differ between the decreasing and stable SBP trajectory groups. In this longitudinal CKD cohort study, compared with stable SBP trajectory, increasing SBP trajectory was associated with higher risk for adverse kidney outcome, whereas decreasing SBP trajectory showed similar risk.


2018 ◽  
Author(s):  
Stacie L Daugherty ◽  
Suma Vupputuri ◽  
Rebecca Hanratty ◽  
John F Steiner ◽  
Julie A Maertens ◽  
...  

BACKGROUND Medication nonadherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient’s ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies. OBJECTIVE The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat. METHODS The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients’ adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients’ prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes. RESULTS This study was funded by the National Heart, Lung, and Blood Institute. Enrollment and follow-up are ongoing and data analysis is expected to begin in late 2020. Planned enrollment is 1130 patients. On the basis of evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes. CONCLUSIONS The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition—hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations. CLINICALTRIAL ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB). INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12498


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Adam H de Havenon ◽  
Eric Goldstein ◽  
Stephanie Lyden ◽  
Jennifer Majersik

Background: The Systolic Blood Pressure Intervention Trial enrolled patients aged 50 or older with at least one cardiovascular disease risk factor, but free of prior symptomatic stroke. Patients were assigned to two blood pressure reduction goals (<140 versus 120 mm Hg). There was not a significant difference in the rate of stroke, making this an ideal cohort to refine risk prediction of primary stroke, which is understudied in patients with adequate blood pressure control and a rigorously adjudicated outcome of stroke. Methods: The primary outcome is ischemic stroke. We fit Cox models to the primary outcome and evaluated all baseline demographic variables to determine which would be most predictive of stroke, which we then used to create a prediction score. Results: We included 9,361 patients with a mean (SD) age of 67.9 (9.4) years and 171 (1.8%) patients met the primary outcome of stroke. For our prediction model, we gave one point each for history of TIA, atrial fibrillation, congestive heart failure, or diabetes. Patients with 2 or more points were collapsed, making three possible scores of 0, 1, and 2, which had rates of stroke of 1.5% (117/8042), 3.2% (30/933), and 6.2% (24/386) (p<0.001). Compared to a score of 0, the hazard ratios for stroke of score 1 and 2 were 2.3 (95% CI, 1.6-3.5) and 4.6 (95% CI, 2.9-7.1) (both p<0.001) (Figure 1). Conclusion: A simple scoring system can improve prediction of ischemic stroke from 1.8% to 6.2% in patients with no prior history of stroke and excellent blood pressure control. This information could be used to improve patient selection for clinical trials or for identifying patients for more aggressive primary prevention strategies.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Xueyan Feng ◽  
Ka Lung Chan ◽  
Jill Abrigo ◽  
Linda Lan ◽  
Yannie Soo ◽  
...  

Objective: Patients with symptomatic intracranial atherosclerotic stenosis (sICAS) have a high risk of stroke recurrence. There is debate over an optimal blood pressure (BP) lowering target in secondary stroke prevention in such patients, when some factors (e.g., impaired cerebral perfusion) may alter the relationship between BP and risk of stroke recurrence. In this study, we investigated whether translesional pressure gradient across sICAS lesions would also alter such relationship. Methods: We recruited patients with sICAS (50-99% stenosis) confirmed in CT angiography (CTA). Computational fluid dynamics (CFD) models were built based on CTA to simulate blood flow across sICAS and calculate the translesional pressure ratio (PR, the ratio of pressures distal and proximal to a lesion). PR ≤ median was defined as low PR, indicating larger translesional pressure gradient and hence restricted downstream perfusion. The primary outcome was recurrent ischemic stroke in the same territory in 1 year. We investigated the interaction of PR and mean systolic BP (SBP) during follow-up in determining the risk of the primary outcome. Results: Among 157 patients, the median PR was 0.93. Multivariate Cox regression revealed significant PR-SBP interaction on the primary outcome (p=0.025): in patients with normal PR, the risk of primary outcome significantly decreased with lower SBP during follow-up (for 10 mmHg decrement: HR 0.46; p=0.018); however, in those with low PR, mean SBP ≤130 mmHg was associated with significantly increased risk of primary outcome, compared with 130<SBP<150mmHg (HR 5.08; p=0.043) (Figure). Conclusion: Intensive BP lowering may increase the risk of stroke recurrence in sICAS patients with a large translesional pressure gradient, warranting further investigation. PR by CFD models may yield a promising indicator to differentiate sICAS patients for different BP management strategies for better secondary stroke prevention.


Circulation ◽  
2015 ◽  
Vol 131 (suppl_1) ◽  
Author(s):  
Zhaohui Cui ◽  
Kimberly P Truesdale ◽  
Patrick T Bradshaw ◽  
Jianwen Cai ◽  
June Stevens

Introduction: The 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults recommended weight loss for obese adults in order to reduce their cardiovascular disease (CVD) risk. However, not all obese adults develop CVD and approximately 17% of obese Americans in the 1999-2004 NHANES were metabolically healthy. The absence of abnormal CVD risk factors in this subgroup of obese adults indicates that some individuals are resistant to excess adiposity and positive energy balance, and raises the question of whether all obese adults should be recommended for weight loss treatment. We know of no study that has examined whether metabolically healthy obese (MHO) adults respond to weight changes the same way as metabolically healthy normal weight adults (MHNW). Also, no study has compared the effects of weight loss, weight maintenance and weight gain on CVD risk factors in MHO adults. Hypothesis: We hypothesized that the effects of weight change would be different in MHNW and MHO adults, with MHO adults having less stable risk factors, and that weight loss has a protective effect on CVD risk factors in the MHO compared to weight maintenance and weight gain. Methods: Data were from 2,710 MHO and MHNW participants in the Atherosclerosis Risk in Communities (ARIC) study. Four examinations yielded 4,541 observations over sequential 3-year intervals. Metabolically healthy was defined as absence of all components of metabolic syndrome, excluding waist circumference, at the beginning of a 3-year interval. Mixed effect models were applied to individually compare changes in five CVD risk factors (systolic blood pressure, diastolic blood pressure, triglycerides, high-density lipoprotein cholesterol and glucose) in MHO and MHNW adults within 3 weight change categories (<3% weight loss, weight maintenance (±3%) and >3% weight gain). Results: Weight loss was associated with small or no changes in the five CVD risk factors in both MHO and MHNW adults. Weight maintenance was associated with larger increases in MHO compared to MHNW adults in triglycerides (mean ± standard error: 10.0±1.7 vs. 6.5±1.0 mg/dL) and glucose (1.7±0.4 vs. 0.9±0.2 mg/dL). Weight gain was associated with larger increases in systolic (8.6±0.6 vs. 6.2±0.4 mmHg) and diastolic (3.9±0.4 vs. 2.5±0.3 mmHg) blood pressure, triglycerides (22.0±1.8 vs. 16.0±1.1 mg/dL) and glucose (4.9±0.4 vs. 1.9±0.3 mg/dL) among the MHO compared to the MHNW. MHO weight losers experienced more favorable changes in the five CVD risk factors compared to MHO weight maintainers (p<0.04) or gainers (p<0.0001). Conclusions: We showed that compared to MHNW, MHO adults experienced similar changes in CVD risk factors with weight loss and larger increases with weight maintenance and gain. Our study supports the 2013 Guideline that primary health care providers should recommend weight loss treatment for MHO patients.


Circulation ◽  
2014 ◽  
Vol 129 (suppl_1) ◽  
Author(s):  
Ebenezer T Oni ◽  
Ehimen Aneni ◽  
Maribeth Rouseff ◽  
Thinh Tran ◽  
Henry Guzman ◽  
...  

Negative impact of CVD as the leading cause of death in the US is worsened by the significant burden of obesity and associated morbidity and concerns about the growing population inactivity. The American Heart Association has emphasized worksite-based interventions to improve CV health. We evaluated the benefits of improved physical activity(PA) and weight loss(WL) among employees of the Baptist Health South Florida enrolled in a wellness intervention program. Methods: Employees with two or more Cardio-metabolic risk factors , such as total cholesterol ≥ 200 mg/dl, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, hemoglobin A1C ≥ 6.5%, and body mass index (BMI) ≥ 30 were enrolled in an intervention program themed “My unlimited potential”. Interventions were focused on diet and PA modifications. We defined improved physical activity as the difference in the metabolic equivalents (METs) at 12 weeks follow-up and at baseline. WL (lbs) was the difference in weight at follow-up. The relationship between WL and changes in METs was explored in an ordered logistic regression. Results: Overall 203 (48±10 years, 78% females) employees were enrolled with a retention rate of 89% (n=181) at 12 weeks follow-up. At baseline the median weights was 211 lbs., and mean METs- 8.6, while at follow-up the median weight was 200 lbs, and the mean METs 11. At 12 weeks follow up 38% had significant WL (lost >5% of baseline weight). The median WL was 8.4 (IQR 4.8-13.0) lbs and the mean change in METs was 2.4±1.8. Median WL increased with increasing tertiles of METs change; tertile1- 6.5(4-11) lbs., tertile2- 9(6-13)lbs. tertile3- 11(7-15)lbs. Increased PA was related to increased WL across BMI categories adjusting for age, gender and baseline weight. Conclusion: This study points strongly toward the benefit of increasing PA among other lifestyle modification interventions in controlling weight. Although further follow-up of this population to evaluate sustainability of change is needed, our results clearly relate improved PA and health.


Stroke ◽  
2020 ◽  
Vol 51 (12) ◽  
pp. 3733-3736
Author(s):  
Ka-Ho Wong ◽  
Katherine Hu ◽  
Cecilia Peterson ◽  
Nazanin Sheibani ◽  
Georgios Tsivgoulis ◽  
...  

Background and Purpose: Diabetic retinopathy (DR) is a common microvascular complication of diabetes, which causes damage to the retina and may lead to rapid vision loss. Previous research has shown that the macrovascular complications of diabetes, including stroke, are often comorbid with DR. We sought to explore the association between DR and subsequent stroke events. Methods: This is a secondary analysis of patients enrolled in the ACCORD Eye study (Action to Control Cardiovascular Risk in Diabetes). The primary outcome was stroke during follow-up. The exposure was presence of DR at study baseline. We fit adjusted Cox proportional hazards models to provide hazard ratios for stroke and included interaction terms with the ACCORD randomization arms. Results: We included 2828 patients, in whom the primary outcome of stroke was met by 117 (4.1%) patients during a mean (SD) of 5.4 (1.8) years of follow-up. DR was present in 874 of 2828 (30.9%) patients at baseline and was more common in patients with than without incident stroke (41.0% versus 30.5%; P =0.016). In an adjusted Cox regression model, DR was independently associated with incident stroke (hazard ratio, 1.52 [95% CI, 1.05–2.20]; P =0.026). This association was not affected by randomization arm in the ACCORD glucose ( P =0.300), lipid ( P =0.660), or blood pressure interventions ( P =0.469). Conclusions: DR is associated with an increased risk of stroke, which suggests that the microvascular pathology inherent to DR has larger cerebrovascular implications. This association appears not to be mediated by serum glucose, lipid, and blood pressure interventions.


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