Contemporary Clinical Trials Communications 2020-Jun
Protocol and recruitment results from a 13-week randomized controlled trial comparing the effects of different doses of nitrate-rich beetroot juice on cognition, cerebral blood flow and peripheral vascular function in overweight and obese older people.
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Abstrakts
Background
Nitrate-rich food can increase NO production and may induce positive effects on brain function. This study examined the feasibility of a randomized clinical trial (RCT) testing the effects of prolonged consumption of incremental doses of dietary nitrate (NO3-) in overweight and obese older participants. Secondary aims tested dose-dependent changes in cognitive, vascular and pulmonary functions and cerebral blood flow (CBF).Methods
This was a single blind, four-arm parallel RCT conducted in 60 overweight and obese older participants. Eligible participants were randomized to:1) high NO3- (140 ml of beetroot juice (BJ) per day, ~800 mg of NO3-/day), 2) moderate NO3- (70 ml of BJ per day, ~400 mg of NO3-/day), 3) low NO3- (70 ml on alternate days, ~400 mg of NO3-) or 4) NO3- depleted (70 ml on alternate days, ~0.001 mg of NO3). Measurements of cognitive, vascular and pulmonary functions and CBF were conducted at baseline and 13-weeks NO3- intake was assessed by six 24-h recalls, and by measuring NO3- intake biomarkers. Feasibility was assessed by obtaining qualitative feedback and evaluating trial recruitment, retention, compliance with study visits and measurement protocols.