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

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 health...

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Veröffentlicht in:The lancet. Diabetes & endocrinology 2019-09, Vol.7 (9), p.673-683
Hauptverfasser: Kraus, William E, Bhapkar, Manjushri, Huffman, Kim M, Pieper, Carl F, Krupa Das, Sai, Redman, Leanne M, Villareal, Dennis T, Rochon, James, Roberts, Susan B, Ravussin, Eric, Holloszy, John O, Fontana, Luigi
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container_end_page 683
container_issue 9
container_start_page 673
container_title The lancet. Diabetes & endocrinology
container_volume 7
creator Kraus, William E
Bhapkar, Manjushri
Huffman, Kim M
Pieper, Carl F
Krupa Das, Sai
Redman, Leanne M
Villareal, Dennis T
Rochon, James
Roberts, Susan B
Ravussin, Eric
Holloszy, John O
Fontana, Luigi
description 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. 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. 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
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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. 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. 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. 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. National Institute on Aging and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.]]></description><identifier>ISSN: 2213-8587</identifier><identifier>EISSN: 2213-8595</identifier><identifier>DOI: 10.1016/S2213-8587(19)30151-2</identifier><identifier>PMID: 31303390</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Adult ; Blood Pressure ; Caloric Restriction ; Cardiovascular Diseases - blood ; Cardiovascular Diseases - diet therapy ; Cardiovascular Diseases - physiopathology ; Cardiovascular Diseases - prevention &amp; control ; Cholesterol, LDL - blood ; Female ; Glucose Tolerance Test ; Humans ; Male ; Metabolic Diseases - blood ; Metabolic Diseases - diet therapy ; Metabolic Diseases - physiopathology ; Metabolic Diseases - prevention &amp; control ; Middle Aged ; Overweight - blood ; Overweight - complications ; Overweight - physiopathology ; Overweight - prevention &amp; control ; Prospective Studies ; Time Factors ; Treatment Outcome ; Weight Loss ; Young Adult</subject><ispartof>The lancet. 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Diabetes &amp; endocrinology</title><addtitle>Lancet Diabetes Endocrinol</addtitle><description><![CDATA[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. 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. 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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. 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National Institute on Aging and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.]]></description><subject>Adult</subject><subject>Blood Pressure</subject><subject>Caloric Restriction</subject><subject>Cardiovascular Diseases - blood</subject><subject>Cardiovascular Diseases - diet therapy</subject><subject>Cardiovascular Diseases - physiopathology</subject><subject>Cardiovascular Diseases - prevention &amp; control</subject><subject>Cholesterol, LDL - blood</subject><subject>Female</subject><subject>Glucose Tolerance Test</subject><subject>Humans</subject><subject>Male</subject><subject>Metabolic Diseases - blood</subject><subject>Metabolic Diseases - diet therapy</subject><subject>Metabolic Diseases - physiopathology</subject><subject>Metabolic Diseases - prevention &amp; control</subject><subject>Middle Aged</subject><subject>Overweight - blood</subject><subject>Overweight - complications</subject><subject>Overweight - physiopathology</subject><subject>Overweight - prevention &amp; 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Diabetes &amp; endocrinology</jtitle><addtitle>Lancet Diabetes Endocrinol</addtitle><date>2019-09</date><risdate>2019</risdate><volume>7</volume><issue>9</issue><spage>673</spage><epage>683</epage><pages>673-683</pages><issn>2213-8587</issn><eissn>2213-8595</eissn><abstract><![CDATA[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. 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. 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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. 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. National Institute on Aging and National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health.]]></abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>31303390</pmid><doi>10.1016/S2213-8587(19)30151-2</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record>
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subjects Adult
Blood Pressure
Caloric Restriction
Cardiovascular Diseases - blood
Cardiovascular Diseases - diet therapy
Cardiovascular Diseases - physiopathology
Cardiovascular Diseases - prevention & control
Cholesterol, LDL - blood
Female
Glucose Tolerance Test
Humans
Male
Metabolic Diseases - blood
Metabolic Diseases - diet therapy
Metabolic Diseases - physiopathology
Metabolic Diseases - prevention & control
Middle Aged
Overweight - blood
Overweight - complications
Overweight - physiopathology
Overweight - prevention & control
Prospective Studies
Time Factors
Treatment Outcome
Weight Loss
Young Adult
title 2 years of calorie restriction and cardiometabolic risk (CALERIE): exploratory outcomes of a multicentre, phase 2, randomised controlled trial
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