Formula 1 Clinical Trials

Results of 3 separate independent clinical studies show that “Herbalife’s Formula 1 is more effective for weight management than conventional diet.”

Several clinical studies have been completed to show the effectiveness of Herbalife’s Formula 1 Nutritional Shake Mix. The Formula 1 Studies, conducted at University of California, Los Angeles; University of Ulm, Germany; and Seoul University National Hospital, Korea, showed that using Formula 1 meal replacement twice a day led to effective weight loss. Individuals who used Formula 1 and who had certain weight related conditions, showed an improvement in those conditions as a result of using Formula 1 for a weight loss.

University of Ulm, Germany, Clinical Study

“Increased Protein Intake Using Protein Enriched Meal Replacements Compared to Conventional Protein Intake and Meal Replacements in Overweight Subjects”

This study enrolled 110 people who were overweight and followed them over a 12 month period to establish the effect of different levels of protein in the diet on weight management. Part 1 of the study lasted 3 months. One of the groups – the high protein group – followed a weight management program with two meals replaced by Formula 1(European Formula) shakes made with milk and extra protein in the form of European Personalized Protein Powder. The other group got a standard amount of protein in the diet. They did not use a meal replacement shake and were instructed to eat a standard amount of protein from an all-food calorie controlled diet. For the remaining nine months of the study, both groups used one meal replacement shake a day as part of their plan, and the groups maintained the different levels of protein intake in the diet they had consumed during the previous three months.

The overall finding confirmed that drinking protein-enriched meal replacement shakes lead to more effective weight-management than limiting calories alone. The study showed us that when counting calories, drinking two Formula 1 shakes as meal replacements is a more effective way to manage weight than a conventional food diet. A significant additional finding was that at the end of the study, 64 percent of those in the high protein group were considered to be at much lower risk of common health problems associated with being over-weight, compared with 41 percent who consumed the standard amount of protein.

Seoul University National Hospital, Korea, Clinical Study

The study, published in the International Journal of Clinical Practice, followed 75 obese men and women with the metabolic syndrome – a cluster of factors including high blood pressure, a large waist measurement, elevated blood sugar and triglycerides, and low blood levels of `good` HDL cholesterol – for a period of 12 weeks. All subjects replaced two meals a day with liquid meal replacements (Herbalife Formula 1, Korean formula) but were randomly assigned to consume a diet of either a standard amount of protein – about 15 percent of total calories – or double the amount of protein from a higher protein plan.

At the end of 12 weeks, both groups lost weight and both groups lost weight in the belly area. But, in the subjects who followed the diet most strictly, the people in the high protein group lost more body fat (and less lean body mass) than the people consuming the standard amount of protein.

“These findings indicate that meal replacements are a very valuable strategy for losing weight and body fat,” said Belong Cho, M.D., Ph.D., of the Department of Family Medicine at Seoul National University Hospital and lead researcher on the study. “With the increasing incidence of overweight and obesity in Korea, there is a critical need to find ways to help individuals lose weight and decrease their risk of developing obesity-related disorders such the metabolic syndrome,” he added.

Fish Oil with Calorie Restricted Diet and Meal Replacement
Clinically Effective for Metabolic Syndrome Management

On June 18, 2015, Herbalife [NYSE:HLF] released data from a clinical study it conducted in partnership with Taipei Medical University, which showed:

“The combination of meal replacement, fish oil and a calorie-restricted diet led to effective weight management and improvements in metabolic syndrome among participants in the study.”

This is the first clinical study of its kind in Taiwan, and results show that over a 12-week period, participants lost, on average, 4.5kg in weight, 6.5cm in waist circumference, and had a 2.5% reduction in body fat percentage. In addition, the fasting blood glucose level, the triglyceride level, and the low-density lipoprotein-cholesterol (LDLc) level were also controlled by this method. This clinical study recruited 188 volunteer patients with metabolic syndrome in Taiwan. They were randomly assigned to one of four groups — “calorie restricted diet”; “calorie restricted diet with meal replacement”; “calorie restricted diet with fish oil”; and “calorie restricted diet with meal replacement and fish oil” groups to conduct a controlled diet and were observed over a 12-week period. 179 participants successfully completed the study.

The research results showed that, on average, the participants of the “calorie restricted diet with fish oil” group lost 4.5kg in weight, 6.5cm in waist circumference, and had a 2.5% reduction in the body fat percentage. Furthermore, in comparison with the other three groups, it was found that the “calorie restricted diet with meal replacement and fish oil” also experienced an improvement and stability in the levels of fasting blood glucose, triglycerides, LDLc, and the blood pressure with improvement in the overall metabolic syndrome.The results from the study have been published in the “Journal of Functional Foods”, a well-known journal in the food science research field, and the “European Journal of Clinical Nutrition”, an internationally renowned nutrition journal.

David Heber, M.D., Ph.D., F.A.C.P., F.A.S.N., chairman of the Herbalife Nutrition Institute and the Nutrition Advisory Board, said:

“Metabolic syndrome is a common condition affecting between 20-30 percent of middle-aged adults in many countries. It is characterized by increases in waist circumference, fasting blood sugar, cholesterol, and blood pressure. Metabolic syndrome increases the risk of diabetes and heart disease. Among Asians, this condition is increasingly common even at normal body weights. The clinical research conducted in partnership between Herbalife [NYSE:HLF] and Taipei Medical University is an important study that demonstrates the effectiveness of combining meal replacement and Omega-3 fatty acids for weight management plan in subjects with metabolic syndrome. Obesity and the consequent metabolic syndrome, poses significant physical and economic burdens, with Asia being the epicentre of this global epidemic. It is encouraging to see what we believe to be meaningful information to help delay or even prevent the development of serious health problems by improving metabolic syndrome. This study and other research conducted by the company are Herbalife’s contribution to help combat the global obesity epidemic.”

Further findings based upon all three Formula 1 studies show that the use of Herbalife’s Formula 1 and Formula 3 (PPP) can support a weight-loss program, and the continued use of Herbalife Formula 1 after initial weight loss can help to maintain results. using Herbalife’s Formula 1 shakes as part of a balanced and varied diet helps maintain good overall health by delivering nutrients to the body and helps maintain a healthy weight.

Highs and Lows for Weight Management

Dr. David Heber further commented that the low GI diet can lower insulin secretion in human bodies, reduce calorie production, and reduce lipid formation. Furthermore, fish oils contain rich Omega-3 fatty acids, which can dampen inflammatory reactions and consequently lower the levels of blood LDL and triglycerides to prevent occurrence of cardiovascular disease and efficiently improve metabolic syndrome.