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Iris Shai, R.D., Ph.D., Dan Schwarzfuchs, M.D., Yaakov Henkin, M.D., Danit R. Shahar, R.D., Ph.D.,,etc The Dietary Intervention Randomized Controlled Trial.

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Presentation on theme: "Iris Shai, R.D., Ph.D., Dan Schwarzfuchs, M.D., Yaakov Henkin, M.D., Danit R. Shahar, R.D., Ph.D.,,etc The Dietary Intervention Randomized Controlled Trial."— Presentation transcript:

1 Iris Shai, R.D., Ph.D., Dan Schwarzfuchs, M.D., Yaakov Henkin, M.D., Danit R. Shahar, R.D., Ph.D.,,etc The Dietary Intervention Randomized Controlled Trial (DIRECT) N ENGL J MED 2008 vol. 359 no. 3 R1 Jung-kook Wi / Prof. Sung-woon Kim 1

2 Obesity To test the effectiveness and safety of several widely used weight-loss diets Low-carbohydrate diets Vs Low-fat, energy-restricted diets 2

3 Recent 1-year trial Low-carbohydrate diet  Alternative to a low-fat diet for weight loss  Favorable metabolic effects Longerterm studies : lacking Mediterranean diet  Moderate fat & high proportion of monounsaturated fat  Cardiovascular benefit / Weight loss Common limitations of dietary trials High attrition rates (15 to 50% / year) Small size Short duration Lack of assessment of adherence Unequal intensity of intervention 3

4 DIRECT Dietary Intervention Randomized Controlled Trial For 2 year Effectiveness & safety Low-fat, restricted- calorie diet Vs Mediterranean, restricted-calorie diet Vs Low-carbohydrate, non–restricted calorie diet 4

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6 July 2005 ~ June 2007 In Dimona, Israel, in a workplace at a research center with an on-site medical clinic Age of 40 ~ 65 years BMI > 27 kg/m 2 Type 2 DM (ADA criteria) Coronary heart disease 6

7 Persons were excluded Pregnant or lactating Cr. level > 2 mg/dL Liver dysfunction Gastrointestinal problems Active cancer Another diet trial The participants Randomly assigned within strata of sex, age, BMI, history of coronary heart disease, history of type 2 diabetes and current use of statins. 7

8 The restricted-calorie diet American Heart Association guidelines 1500 kcal / day for women 1800 kcal / day for men 30% of calories - fat 10% of calories - saturated fat A intake of 300 mg of cholesterol/day Low-fat grains, vegetables, fruits To limit their consumption of additional fats, sweets, and high-fat snacks 8

9 The moderate-fat, restricted-calorie Rich in vegetable Low in red meat, with poultry and fish replacing beef and lamb. 1500 kcal/day for women 1800 kcal/day for men No more than 35% of calories from fat The main sources of added fat were 30 to 45 g of olive oil and a handful of nuts (five to seven nuts, <20 g) per day Recommendations of Willett and Skerrett 9

10 Low-carbohydrate, non–restricted-calorie diet Induction phase - 20 g of carbohydrates per day for the 2-month A gradual increase to a maximum of 120 g per day to maintain the weight loss The intakes of total calories, protein, and fat were not limited To avoid trans fat. Based on the Atkins diet 10

11 Weight Height >> BMI Waist circumference Blood samples 11

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17 Only Mediterranean-diet group Diabetes : decrease in fasting plasma glucose levels The low-fat group Diabetes : increase in plasma glucose levels There was no significant change in plasma glucose level among the participants without diabetes 17

18 Insulin levels Both (DM / without DM) Decreased significantly in all diet groups The decrease in HOMA-IR at 24 months Mediterranean diet >> The low-fat diet 18

19 Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. The more favorable effects On lipids - the low-carbohydrate diet On glycemic control - the Mediterranean diet suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions 19


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