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2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial.

Publication ,  Journal Article
Kraus, WE; Bhapkar, M; Huffman, KM; Pieper, CF; Krupa Das, S; Redman, LM; Villareal, DT; Rochon, J; Roberts, SB; Ravussin, E; Holloszy, JO ...
Published in: Lancet Diabetes Endocrinol
September 2019

BACKGROUND: For several cardiometabolic risk factors, values considered within normal range are associated with an increased risk of cardiovascular morbidity and mortality. We aimed to investigate the short-term and long-term effects of calorie restriction with adequate nutrition on these risk factors in healthy, lean, or slightly overweight young and middle-aged individuals. METHODS: CALERIE was a phase 2, multicentre, randomised controlled trial in young and middle-aged (21-50 years), healthy non-obese (BMI 22·0-27·9 kg/m2) men and women done in three clinical centres in the USA. Participants were randomly assigned (2:1) to a 25% calorie restriction diet or an ad libitum control diet. Exploratory cardiometabolic risk factor responses to a prescribed 25% calorie restriction diet for 2 years were evaluated (systolic, diastolic, and mean blood pressure; plasma lipids; high-sensitivity C-reactive protein; metabolic syndrome score; and glucose homoeostasis measures of fasting insulin, glucose, insulin resistance, and 2-h glucose, area-under-the curve for glucose, and insulin from an oral glucose tolerance test) analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00427193. FINDINGS: From May 8, 2007, to Feb 26, 2010, of 238 participants that were assessed, 218 were randomly assigned to and started a 25% calorie restriction diet (n=143, 66%) or an ad libitum control diet (n=75, 34%). Individuals in the calorie restriction group achieved a mean reduction in calorie intake of 11·9% (SE 0·7; from 2467 kcal to 2170 kcal) versus 0·8% (1·0) in the control group, and a sustained mean weight reduction of 7·5 kg (SE 0·4) versus an increase of 0·1 kg (0·5) in the control group, of which 71% (mean change in fat mass 5·3 kg [SE 0·3] divided by mean change in weight 7·5 kg [0·4]) was fat mass loss. Calorie restriction caused a persistent and significant reduction from baseline to 2 years of all measured conventional cardiometabolic risk factors, including change scores for LDL-cholesterol (p<0·0001), total cholesterol to HDL-cholesterol ratio (p<0·0001), and systolic (p<0·0011) and diastolic (p<0·0001) blood pressure. In addition, calorie restriction resulted in a significant improvement at 2 years in C-reactive protein (p=0·012), insulin sensitivity index (p<0·0001), and metabolic syndrome score (p<0·0001) relative to control. A sensitivity analysis revealed the responses to be robust after controlling for relative weight loss changes. INTERPRETATION: 2 years of moderate calorie restriction significantly reduced multiple cardiometabolic risk factors in young, non-obese adults. These findings suggest the potential for a substantial advantage for cardiovascular health of practicing moderate calorie restriction in young and middle-aged healthy individuals, and they offer promise for pronounced long-term population health benefits. FUNDING: National Institute on Aging and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.

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Published In

Lancet Diabetes Endocrinol

DOI

EISSN

2213-8595

Publication Date

September 2019

Volume

7

Issue

9

Start / End Page

673 / 683

Location

England

Related Subject Headings

  • Young Adult
  • Weight Loss
  • Treatment Outcome
  • Time Factors
  • Prospective Studies
  • Overweight
  • Middle Aged
  • Metabolic Diseases
  • Male
  • Humans
 

Citation

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Kraus, W. E., Bhapkar, M., Huffman, K. M., Pieper, C. F., Krupa Das, S., Redman, L. M., … CALERIE Investigators, . (2019). 2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial. Lancet Diabetes Endocrinol, 7(9), 673–683. https://doi.org/10.1016/S2213-8587(19)30151-2
Kraus, William E., Manjushri Bhapkar, Kim M. Huffman, Carl F. Pieper, Sai Krupa Das, Leanne M. Redman, Dennis T. Villareal, et al. “2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial.Lancet Diabetes Endocrinol 7, no. 9 (September 2019): 673–83. https://doi.org/10.1016/S2213-8587(19)30151-2.
Kraus WE, Bhapkar M, Huffman KM, Pieper CF, Krupa Das S, Redman LM, et al. 2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Sep;7(9):673–83.
Kraus, William E., et al. “2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial.Lancet Diabetes Endocrinol, vol. 7, no. 9, Sept. 2019, pp. 673–83. Pubmed, doi:10.1016/S2213-8587(19)30151-2.
Kraus WE, Bhapkar M, Huffman KM, Pieper CF, Krupa Das S, Redman LM, Villareal DT, Rochon J, Roberts SB, Ravussin E, Holloszy JO, Fontana L, CALERIE Investigators. 2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Sep;7(9):673–683.
Journal cover image

Published In

Lancet Diabetes Endocrinol

DOI

EISSN

2213-8595

Publication Date

September 2019

Volume

7

Issue

9

Start / End Page

673 / 683

Location

England

Related Subject Headings

  • Young Adult
  • Weight Loss
  • Treatment Outcome
  • Time Factors
  • Prospective Studies
  • Overweight
  • Middle Aged
  • Metabolic Diseases
  • Male
  • Humans