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Clinical Studies and Practice

Weight loss maintenance in overweight subjects on ad libitum diets with high or low protein content and glycemic index: the DIOGENES trial 12-month results



A high dietary protein (P) content and low glycemic index (LGI) have been suggested to be beneficial for weight management, but long-term studies are scarce.


The DIOGENES randomized clinical trial investigated the effect of P and GI on weight loss maintenance in overweight or obese adults in eight centers across Europe. This study reports the 1-year results in two of the centers that extended the intervention to 1 year.


After an 8-week low-calorie diet (LCD), 256 adults (body mass index >27 kg m2) were randomized to five ad libitum diets for 12 months: high P/LGI (HP/LGI), HP/high GI (HP/HGI), low P/LGI (LP/LGI), LP/HGI and a control diet. During the first 6 months, foods were provided for free through a shop system and during the whole 12-month period, subjects received guidance by a dietician. Primary outcome variable was the change in body weight over the 12-month intervention period.


During the LCD period, subjects lost 11.2 (10.8, 12.0) kg (mean (95% confidence interval (CI))). Average weight regain over the 12-month intervention period was 3.9 (95% CI 3.0–4.8) kg. Subjects on the HP diets regained less weight than subjects on the LP diets. The difference in weight regain after 1 year was 2.0 (0.4, 3.6) kg (P=0.017) (completers analysis, N=139) or 2.8 (1.4, 4.1) kg (P<0.001) (intention-to-treat analysis, N=256). No consistent effect of GI on weight regain was found. There were no clinically relevant differences in changes in cardiometabolic risk factors among diet groups.


A higher protein content of an ad libitum diet improves weight loss maintenance in overweight and obese adults over 12 months.

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We gratefully acknowledge all food companies for their contributions of foods to the laboratory shops. The DIOGENES trial was funded by the European Commission, contract no. FP6-2005-513946. The funding source had no role in the study design, data collection, data analysis, data interpretation or writing of the report. The majority of the food items in the shops were provided for free by a large number of different food companies. A complete list can be found on Food items to be offered in the shops were selected by the investigators. Companies were in no way involved in the planning, execution or analysis of the study.

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Correspondence to M A van Baak.

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Competing interests

Dr Astrup is currently member of advisory boards for McCain Foods, USA, Global Dairy Platform, USA, JennyCraig, USA, and McDonald’s, USA, and has received funding for other studies from about 100 food companies covering all food groups. Dr Saris is corporate scientist, Human Nutrition for DSM, The Netherlands, and received research grants and food donations from several food companies. The remaining authors declare no conflict of interest.

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Aller, E., Larsen, T., Claus, H. et al. Weight loss maintenance in overweight subjects on ad libitum diets with high or low protein content and glycemic index: the DIOGENES trial 12-month results. Int J Obes 38, 1511–1517 (2014).

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  • body weight changes
  • dietary proteins
  • glycemic index
  • risk factors

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