Meal Replacement Program Shows Glycemic, Weight Improvements for Patients With T2D, Obesity

Amy Rothberg, MD, PhD

The OPTIFAST meal replacement program, a medically supervised intervention, has demonstrated significant improvements in hemoglobin A1C (HbA1C) and fasting glucose levels in patients with type 2 diabetes when compared with the standard of care.

In a late-breaking analysis at the American Diabetes Association’s 78^th Annual Scientific Sessions in Orlando, Florida, the OPTIWIN trial included 273 patients, randomized to either the program (n = 135) or a conventional food-based diet and lifestyle intervention (n = 138). Among those on the meal program with follow-up data at weeks 26 and 52 (n= 30), a higher proportion of patients no longer met the criteria for type 2 diabetes at week 26 compared to the comparator group (P = .008), and while that trend continued through week 52, the difference was not significant.

“This is just one more really successful option for treating patients faced with obesity,” Amy Rothberg, MD, PhD, an associate professor at the University of Michigan told MD Mag. “Certainly, it allows for better utilization or at least a decrease in medical utilization.”

“This just makes the process so much simpler,” she added.

The program, which transitions ultimately transitions participants to self-prepared meals in conjunction with a comprehensive weight loss education and support, is available at more than 400 locations in the United States.

In addition to its simplicity, the clinical supervision is among the main reasons the program is so successful, Rothberg stressed. Which is, Grenye O'Malley, MD, from the Icahn School of Medicine at Mount Sinai, said to MD Mag, why dietitians need to be involved in the process of diabetes management as often as possible. Although, unfortunately, she noted, due to a lack of resources, the amount of opportunities physicians and dietitians have to interact in a consistent setting is often limited.

This is where the education and transition period of meal preparation to the patients comes into play. The education on diet is often lacking for patients, Rothberg said, adding to why teaching them how to prepare meals is all the more essential.

“OPTIFAST deliveries the prescribed number of calories and the micronutrients everyone needs in the day. There’s no guesswork,” Rothberg said. “Even when people do their best, we still know they don’t account for a lot of what they consume. This controls for those factors. When people are on it they have really good suppression of hunger, which is one of the things you need to mitigate when people are trying to lose weight.”

In terms of Hb1AC, there was a 0.2% improvement for patients on the program, lowering from 5.7% to 5.5% from baseline to week 26 and remaining at that level at week 52. In comparison, the comparator group experienced a slight 0.1% drop to 5.6% from baseline at week 26, but was ultimately unchanged at week 52, back to 5.7%, a significant difference from the meal program group (P <.05).

Additionally, the reduction in fasting blood glucose was significantly greater at 26 weeks in the OPTIFAST group (P = .02). Fasting blood glucose lowered from 101 to 94 mg/dL among participants randomized to the program, on average, compared with 101 to 99 mg/dL among those in the comparator group at week 26.

At week 26, the mean relative weight loss was 12.2 kg for the meal program group compared to 5.9 kg in the conventional intervention group (difference, 6.2 ±.08; P <.0001). At week 52, the loss was 10.3 kg and 5.5 kg, respectively (difference, 4.8 ±.08; P <.0001).

The rate of patients achieving a ≥5%, ≥10%, and ≥15% weight loss by week 52 was 64%, 44%, and 30% for the OPTIFAST group, compared with 42%, 22%, and 12% for the comparator group (P <.001, for ≥5% and ≥10% loss; P <.05 for ≥15% loss).

“The success of the OPTIFAST Program lies in its multidisciplinary approach to helping patients manage obesity through medical monitoring, nutrition education, physical activity guidance, total meal replacement and behavior modification support,” said Krys Araujo Torres, MD, the head of U.S. Medical Affairs for Nestlé Health Science, in a statement. “The OPTIWIN trial confirms that this comprehensive approach to helping patients lose weight has beneficial outcomes for diabetes and should be more strongly considered than a weight loss plan focused on a reduced-calorie diet only.”

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