Nestlé initiates a year-Long OPTI-WIN clinical trial for weight loss and maintenance

The OPTIFAST Program was developed in 1974 to fill the growing need to address obesity in a healthy and effective way

Nestlé Health Science has announced that it will begin enrolling participants in a new clinical trial on its OPTIFAST programme.

This year-long study, named OPTI-WIN, will evaluate the effectiveness of the OPTIFAST programme on weight loss and maintenance in comparison with a modified diabetes prevention programme, a recognised standard lifestyle intervention.

The announcement was made during Obesity Week 2015, the largest gathering of physicians, surgeons and other healthcare professionals from around the world dedicated to the latest research and care of people with obesity.

'Obesity is a complex health issue, and experts agree that successful weight loss requires a mix of behavioural lifestyle counselling, changes to the diet and exercise,' said Jamy Ard, MD, Principal Investigator of OPTI-WIN and Associate Professor of Epidemiology and Prevention at Wake Forest Baptist Medical Center, who also serves as US Medical Director for the OPTIFAST programme. 'This trial will provide a fresh look at OPTIFAST and how it compares with a current standard of care for those looking to lose weight and keep it off.'

OPTIFAST is a comprehensive weight management programme that incorporates medical monitoring, complete meal replacements, behaviour modification and lifestyle education. The program utilises OPTIFAST meal replacement products to achieve the prescribed amount of calories and micronutrients per day. It is a non-surgical option designed for people with a Body Mass Index (BMI) greater than 30.

'OPTIFAST reinforces the need for holistic approaches to help people not only lose weight, but maintain a healthy weight," said Juan Ochoa, MD, Chief Medical Officer for Nestlé Health Science in the United States. 'For four decades, OPTIFAST has been proven to be effective, and more than 80 peer-reviewed publications have documented its results. OPTI-WIN will further add to this depth of science.'

OPTI-WIN will be a 52-week, open, randomised controlled trial. The study will compare the OPTIFAST programme against a food-based control group. Three hundred adults with obesity, aged 18–70, and with BMIs between 30kg/m2 and 55kg/m2, will be enrolled and randomly assigned to either the OPTIFAST or food-based group.

The OPTIFAST group will undergo a portion-controlled, nutritionally balanced weight loss phase with meal replacements of shakes, bars and soups. This phase will be followed by a gradual reintroduction of food. The food-based group will receive a modified diabetes prevention programme diet, specifically with an energy deficit diet based on the American Diabetes Association standards of diabetes care and education, and will meet recommendations endorsed by the American College of Cardiology, the American Heart Association Task Force on Practice Guidelines, The Obesity Society and the American Association of Family Practitioners.

In addition to the respective dietary interventions, both groups will participate in behavioural counselling sessions as well as a moderate exercise programme. The trial will compare these two groups for the degree of weight loss throughout the 52-week study period. Additionally, it will evaluate weight loss maintenance and the percentage of patients who reach their treatment goals, as well as behavioural changes, physical activity levels and other measures. OPTI-WIN will be conducted across 10 sites in the United States. Enrollment is expected to be completed by June 2016.