Study design
abdominal obesity, major illness, cancer, dyslipidemia
MAY, CANCER, DYSLIPIDEMIA
The 18-month DIRECT-PLUS (dietary intervention randomized controlled trial polypenols-unprocessed) trial (ClinicalTrials.gov ID: NCT03020186) aimed to address the residual beneficial effect of a green Mediterranean diet, richer in green plants and lower in meat, compared with other healthy lifestyle strategies. The trial was initiated in May 2017 and was conducted in an isolated workplace (Nuclear Research Center Negev (NRCN), Dimona, Israel), where a monitored lunch was provided. This workplace includes a medical department where most medical measurements and lifestyle intervention sessions were held. Of the 378 volunteers, 294 met the inclusion criteria of age > 30 years and abdominal obesity (waist circumference (WC): men > 102 cm, women > 88 cm) or dyslipidemia (triglycerides > 150 mg/dL and high-density lipoprotein cholesterol ≤ 40 mg/dL for men, ≤ 50 mg/dL for women). The exclusion criteria were an inability to partake in physical activity (PA), a serum creatinine level ≥ 2 mg/dL, disturbed liver function, a major illness that might require hospitalization, pregnancy or lactation for women, presence of active cancer or chemotherapy within the prior 3 years, participation in another trial, treatment with warfarin (given its interaction with vitamin K), and having a pacemaker or platinum implant (due to inability to undergo magnetic resonance imaging).All subjects gave informed consent. The protocol was approved by the Medical Ethics Board and Institutional Review Board at Soroka University Medical Centre, Be’er Sheva, Israel (0280–16-SOR). Participants received no financial compensation.