Flawed from the start? NIH study of diabetics cut short after failing to show effect on heart disease risk

The objective of the 11-year, $220 million NIH funded study made sense – entitled the Look AHEAD trial - to see if an “intensive lifestyle intervention program” focused on improved diet and increased physical activity would lower heart risks, such as fatal and non-fatal stroke and heart attack, among more than 5,000 diabetics. There were of course high expectations, and researchers offered several reasons for the study’s perceived failings, which was recently halted. The National Institutes of Health released this statement on Friday, October 19, 2012.

But, was the study destined to fail from the start?

There is broad recognition about the close association between being overweight or obese, and risk for developing diabetes and heart disease. So, the study’s design went after this association, but did so by focusing exclusively on calories for the diet portion of the intervention and strictly followed dietary composition guidance by groups like the American Diabetes Association and the National Cholesterol Education, which advises a diet of 65% carbohydrate, 15% protein, and 30% fat (with a maximum of 10% of total calories from saturated fat). 

Yes, caloric intake is important to manage weight – the study called for “1200-1800 kcal/day depending on the individual’s baseline weight.” However, the study’s protocol also called for  “commercially available liquid meal replacements that will replace two meals and snacks each day” and a “frozen entrée” for an evening meal. This begs the question, is it surprising there was no effect observed on heart disease risk (even though weight loss was achieved, albeit a much greater percentage in the first year than over the entire timeframe of the study) when people were encouraged to each pre-packed frozen dinners and liquid meal drinks like Ensure.

If you’re curious, take a look at the nutrition labels and ingredients in products like Ensure:

In one bottle:

• ·      250 calories

• ·      40g of carbohydrate, with 22g from sugar (64% of total calories)

• ·      9g of protein (14.4% of total calories)

• ·      6g of total fat, with 1g of saturated fat (21.6% of total calories)

Ingredients: Water, Salt, Corn Syrup, Corn Maltodextrin, Milk Protein Concentrate, Soy Oil, Soy Protein Concentrate, Cocoa Powder (Processed with Alkali), Canola Oil. Less than 0.5% of the Following: Corn Oil, Potassium Citrate, Magnesium Phosphate, Magnesium Chloride, Calcium Phosphate, Soy Lecithin, Sodium Citrate, Sugar, Carrageenan, Choline Chloride, Ascorbic Acid, Natural & Artificial Flavor, Potassium Chloride, dl-Alpha-Tocopheryl Acetate, Ferric Phosphate, Zinc Sulfate, Niacinamide, Manganese Sulfate, Calcium Pantothenate, Cupric Sulfate, Vitamin A Palmitate, Thiamine Chloride Hydrochloride, Pyridoxine Hydrochloride, Riboflavin, Folic Acid, Chromium Chloride, Biotin, Sodium Molybdate, Sodium Selenate, Potassium Iodide, Cyanocobalamin, Phylloquinone, and Vitamin D3.

But a quick glance at the first five ingredients – of which there are 40 total – you will see corn syrup and corn maltodextrin as the third and fourth respectively. Basically, a bottle of lots of sugar with some added vitamins and minerals.

A similar glance at some of the popular frozen meal brands, like Lean Cuisine, shows a similar story of consuming many of the ingredients that undermine health rather than protect against heart disease, like sugar, carbohydrates, and vegetable oils. Here is an example of the beloved Chicken Parmesan dish:

• ·      300 calories

• ·      39g of carbohydrate, with 10g from sugar (52% of total calories)

• ·      18g of protein (24% of total calories)

• ·      8g of total fat (24% of total calories)

Ingredients: TOMATOES, BLANCHED SPAGHETTI (WATER, SEMOLINA), COOKED BREADED WHITE CHICKEN MEAT, GROUND AND FORMED (WHITE CHICKEN MEAT, WATER, SEASONING (MODIFIED FOOD STARCH, SUGAR, POTASSIUM CHLORIDE, YEAST EXTRACT, DEXTROSE, SPICE, ONION POWDER, GARLIC POWDER, PAPRIKA), ISOLATED SOY PROTEIN, SODIUM PHOSPHATE, SALT. BREADED WITH: ENRICHED BLEACHED WHEAT FLOUR (NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), DEXTROSE, SALT, MALTODEXTRIN, PARMESAN CHEESE (PARTIALLY SKIM MILK, CULTURES, SALT, ENZYMES), WHEY, ENZYME MODIFIED PARMESAN CHEESE (PARMESAN CHEESE {MILK, STARTER CULTURE, SALT, ENZYMES}, CREAM, NATURAL FLAVOR), SPICE, ONION POWDER, GARLIC POWDER, PARSLEY, CARAMEL COLOR, SOYBEAN OIL, EXTRACTIVES OF PAPRIKA. BREADING SET IN VEGETABLE OIL), TOMATO PUREE (WATER, TOMATO PASTE), PART SKIM MOZZARELLA CHEESE (CULTURED MILK, SALT, ENZYMES), ONIONS, 2% OR LESS OF WATER, SUGAR, SOYBEAN OIL, BASIL, MODIFIED CORNSTARCH, GARLIC PUREE, SALT, POTASSIUM CHLORIDE, SPICES, SKIM MILK, XANTHAN GUM, FLAVORS. 

Take Away 

So, was this study flawed? How can you make any impact on preventing heart disease – even in the presence of weight loss – when meals are loaded with sugar and carbohydrate? Diets high in both have been linked to worse predictors of heart disease risk and certainly aren’t doing much to help manage diabetes. Chronic and high levels of sugar and carbohydrate consumption require a matched insulin release, the hormone you’re precisely trying to control to prevent and/or manage diabetes.

Diet composition and quality of food matters. This study seems to be another example of how an exclusive focus on caloric consumption has its limitations with respect to overall and long-term health goals. I wonder if different results would have been achieved had all of the intervention group ate fewer calories, a lower composition of carbohydrates/sugars, and foods were all from real, quality sources, like fresh vegetables, meat, fish, fruit, and nuts?

Let me know what you think. Please post a comment.