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A Randomized Controlled Trial

Joanna McMillan-Price, MNutrDiet; Peter Petocz, PhD; Fiona Atkinson, MNutrDiet; Kathleen O’Neill, BSc; Samir Samman, PhD; Katherine Steinbeck, MD, PhD; Ian Caterson, MD, PhD; Jennie Brand-Miller, PhD

Arch Intern Med. 2006;166:1466-1475.

Background  Despite the popularity of low–glycemic index (GI) and high-protein diets, to our knowledge no randomized, controlled trials have systematically compared their relative effects on weight loss and cardiovascular risk.

Methods  A total of 129 overweight or obese young adults (body mass index, 25 [calculated as weight in kilograms divided by the square of height in meters]) were assigned to 1 of 4 reduced-fat, high-fiber diets for 12 weeks. Diets 1 and 2 were high carbohydrate (55% of total energy intake), with high and low GIs, respectively; diets 3 and 4 were high protein (25% of total energy intake), with high and low GIs, respectively. The glycemic load was highest in diet 1 and lowest in diet 4. Changes in weight, body composition, and blood chemistry profile were studied.

Results  While all groups lost a similar mean ± SE percentage of weight (diet 1, –4.2% ± 0.6%; diet 2, –5.5% ± 0.5%; diet 3, –6.2% ± 0.4%; and diet 4, –4.8% ± 0.7%; P = .09), the proportion of subjects in each group who lost 5% or more of body weight varied significantly by diet (diet 1, 31%; diet 2, 56%; diet 3, 66%; and diet 4, 33%; P = .01). Women on diets 2 and 3 lost approximately 80% more fat mass (–4.5 ± 0.5 [mean ± SE] kg and –4.6 ± 0.5 kg) than those on diet 1 (–2.5 ± 0.5 kg; P = .007). Mean ± SE low-density-lipoprotein cholesterol levels declined significantly in the diet 2 group (–6.6 ± 3.9 mg/dL [–0.17 ± 0.10 mmol/L]) but increased in the diet 3 group (+10.0 ± 3.9 mg/dL [+0.26 ± 0.10 mmol/L]; P = .02). Goals for energy distribution were not achieved exactly: both carbohydrate groups ate less fat, and the diet 2 group ate more fiber.

Conclusion  Both high-protein and low-GI regimens increase body fat loss, but cardiovascular risk reduction is optimized by a high-carbohydrate, low-GI diet.

Trial Registration  clinicaltrials.gov Identifier: NCT00254215

Author Affiliations: Human Nutrition Unit, University of Sydney (Mss McMillan-Price, Atkinson, and O’Neill and Drs Samman, Caterson, and Brand-Miller), Department of Statistics, Macquarie University (Dr Petocz), and Metabolism and Obesity Services, Royal Prince Alfred Hospital (Drs Steinbeck and Caterson), Sydney, Australia.

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