A double-blind, randomized, crossover trial protocol of whole hemp seed protein and hemp seed protein hydrolysate consumption for hypertension.

BACKGROUND: Primary hypertension accounts for almost 95% of all cases of high blood pressure and is a major modifiable risk factor for cardiovascular diseases. Lifestyle interventions have been shown to prevent hypertension. One of the prominent potential therapeutic lifestyle strategies to prevent or manage hypertension is increasing dietary protein as a macronutrient or as bioactive peptides. An emerging plant-based protein source that may have anti-hypertensive properties is hemp seed. METHODS/DESIGN: A randomized, double-blind, crossover clinical trial will be conducted on 35 hypertensive participants aged 18-75 years, with a BMI between 18.5 and 40 kg/m2, systolic blood pressure (SBP) between 130 and 160 mmHg and diastolic blood pressure (DBP) ≤ 110 mmHg. The trial will be conducted for a period of 22 weeks and will consist of three treatment periods of 6 weeks, separated by 2-week washout periods. The treatments will be consumed twice a day and consist of 25 g casein, hemp seed protein (HSP), or HSP plus HSP hydrolysate (HSP+). The primary outcome of this trial is 24-h SBP, measured on the first day of first phase and the last day of each phase. Office-measured blood pressure, pulse-wave velocity and augmentation index and anthropometrics will be determined at the first and last days of each period. Also, body composition will be assessed by dual x-ray absorptiometry (DXA) scan on the first day of the first phase and within the last 2 days of each treatment period. Blood samples will be collected on the first and last 2 days of each treatment phase whereas urine samples will be collected on the first day of the first phase plus the last day of each phase to be analyzed for specific biomarkers. DISCUSSION: This trial protocol is designed to evaluate the hypotensive potential of consuming whole HSP, and HSP+, in comparison to casein protein. This study will be the first trial investigating the potential anti-hypertensive benefit of dietary hemp protein plus bioactive peptide consumption in humans. TRIAL REGISTRATION: National Clinical Trial (NCT), ID: NCT03508895. Registered on 28 June 2018. Retrospectively registered on the publicly accessible Registry Databank at ClinicalTrials.gov (http://ClinicalTrials.gov).

Resveratrol Supplementation and Oxidative/Anti-Oxidative Status in Patients with Ulcerative Colitis: A Randomized, Double-Blind, Placebo-controlled Pilot Study.

BACKGROUND AND AIMS: Oxidative stress is involved in both pathogenesis and exacerbation of ulcerative colitis (UC). This study was designed to evaluate whether resveratrol, an excellent anti-oxidant agent, can help in treatment of UC and its related oxidative stress. METHODS AND RESULTS: Fifty six patients with active mild to moderate disease were randomized to receive either 500 mg/day resveratrol capsules or the same amount of placebo for 6 weeks. Before and after the intervention, disease activity, quality of life, and oxidative stress were assessed using the Simple Clinical Colitis Activity Index Questionnaire (SCCAIQ), Inflammatory Bowel Disease Questionnaire-9 (IBDQ-9), and serum level of malondialdehyde (MDA), superoxide dismutase (SOD), and total anti-oxidant capacity (TAC), respectively. Serum SOD (122.28 ± 11.55 to 125.77 ± 10.97) and TAC (9.87 ± 1.51-11.97 ± 1.61) increased, whereas serum MDA (5.62 ± 1.18-3.42 ± 1.01) decreased significantly in resveratrol group (p <0.001). Moreover, resveratrol supplementation significantly decreased disease activity and increased the quality of life (p <0.001). CONCLUSION: Our data indicate that 500 mg/day resveratrol supplementation can improve the disease activity and quality of life in patients with UC at least partially through reduction of oxidative stress. Further studies are needed to determine the optimal dosage of supplementation for these patients.