Three Lifestyle Interventions on Endothelial Function and Cardiometabolic Risk in Obese Patients With Metabolic Syndrome

Summary

Obese patients with metabolic syndrome without diabetes or ischemic heart disease were randomized to three lifestyle interventions: 1. hypocaloric tailored diet with standard recommendations 2. pragmatic healthy style diet adapted to brazilian habits with portion control and pedometers to perform 10000 steps daily recorded or 3. pragmatic healthy style diet adapted to brazilian habits with portion control plus fitness three times a week under direct supervision. The main outcome was brachial reactivity, a surrogate marker of atherosclerosis, and secondary outcomes were cardiometabolic profile, arterial pressure and anthropometric measures: weight,waist circumference and bioimpedanciometry to access fat proportion and insulin sensitivity.

Conditions

• Metabolic Syndrome
• Obesity

Interventions

BEHAVIORAL

hypocaloric diet

patients received individually tailored hypocaloric diet, with 20% of total calories as fat (with 7-8 % of saturated fats), 50 to 65% carbohydrates and 15% to 20% proteins. Total of calories for each patient calculated assuming the ideal body weight to fulfill a BMI of 25 kg⁄ M2. Total daily amount of calories estimated calculating 30 calories/Kg of ideal weight for each subject. Subjects were advised against consuming high fat snacks or additional fats. Alimentary plans specified the number of servings from each food group, and dairy intake was held constant.

BEHAVIORAL

Exercise recommendations

Exercise was advised but not measured: they received recommendations to be physically active and perform 1 hour of aerobic exercise as preferred, everyday.

BEHAVIORAL

Pragmatic diet

Patients received a portable colored handbook with evidence- based recommendations on healthy eating attitudes and pragmatic menus, with low carbohydrates and high protein and vegetables. It included controlled portions (adjusted for individual hand size) for the six meals, with low glucose aliments and whole grains, legumes, yogurt, fruits, olive oils, eggwhite and low fat milk, fiber and a handful of nuts. Portions were tailored according to individual hand size, without calories counting. Beans, farofa and white cheese bread, which are commonly present in Brazilian food, and red meat were allowed, but with portion control.

BEHAVIORAL

Pedometer-based fitness (10,000 steps)

Subjects were provided with pedometers and were instructed to perform at least 10,000 steps daily, diary recorded.

BEHAVIORAL

Structured assisted exercise (fitness)

They were scheduled for a more structured assisted exercise intervention: three bicycle ergometer sessions per week, under direct supervision of the same trained exercise physiologists in each session. Heart rate monitors were used to adjust workload to achieve the target heart rate (75% of the maximum attainable heart rate), as determined by their individual maximal treadmill exercise test. All patients were trained by the same staff, Borg scale was registered in every session and persuasive goal setting was made during exercise sessions

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre

  lead OTHER

Principal Investigators

• Beatriz G Seligman, MD MsC · Serviço de Medicina Interna Hospital de Clinicas de Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-06-30

Primary Completion

2008-12-31

Completion

2009-06-30

Countries

• Brazil

Study Locations