Study design
malignancy, abnormal liver function, abdominal obesity, weight loss, dyslipidemia
DYSLIPIDEMIA
The DIRECT-PLUS trial (ClinicalTrials.gov ID: NCT03020186) was designed as an 18-month study of the effectiveness of a lifestyle intervention program on weight loss and cardiovascular risk reduction. The trial was conducted in an isolated workplace, the Nuclear Research Center Negev (NRCN) in Dimona, Israel, where the participants had access to a monitored lunch programs. Of the 378 volunteers who initially enrolled, 294 met the inclusion criteria of age greater than 30 years with abdominal obesity (waist circumference of over 102cm for men and over 88cm for women) or dyslipidemia (triglycerides greater than 150mg/dL and high-density lipoprotein cholesterol less than or equal to 40mg/dL for men or less than or equal to 50mg/dL for women). The exclusion criteria were an inability to participate in physical activity, abnormal liver function, a serum creatinine level of 2 mg/dL or higher, major illnesses that might require hospitalization, active malignancy or undergoing chemotherapy within the prior 3 years, participation in another trial, treatment with warfarin (due to its interaction with vitamin K), or having an implant that would preclude magnetic resonance imaging (MRI). Furthermore, none of the participants were on continuous steroid or anti-inflammatory treatment. There were no new diagnoses requiring the initiation of anti-inflammatory or steroid therapies during the study. The study protocol was approved by the Soroka University Medical Centre medical ethics board and institutional review board, and all participants provided written informed consent. The participants did not receive any financial compensation or gifts for their participation in the study. Clinical and medical measurements were taken at baseline, 6-months, and 18-months.