Nutritional management of cardiovascular risk factors: A randomized clinical trial

David A. McCarron, Suzanne Oparil, Alan Chait, R. Brian Haynes, Penny Kris-Etherton, Judith S. Stern, Lawrence M. Resnick, Sharon Clark, Cynthia D. Morris, Daniel C. Hatton, Jill A. Metz, Margaret McMahon, Scott Holcomb, Geoffrey W. Snyder, F. Xavier Pi-Sunyer

Research output: Contribution to journalArticle

87 Citations (Scopus)

Abstract

Background: Adherence to dietary recommendations for disease management is often hindered by the complexity of incorporating them into the daily diet. Nutrition and cardiovascular scientists anti food technologists collaborated to develop a prepared meal plan that meets national dietary guidelines for cardiovascular risk reduction. Objective: To assess the clinical effects of this plan, which incorporates all National Academy of Sciences National Research Council recommended dietary allowances for vitamins, minerals, and macronutrients, compared with a patient-selected American Heart Association Step I anti Step II diet plan. Methods: This multicenter, randomized, parallel-intervention trial was conducted at 10 medical centers in the United States and Canada and involved 560 men and women with hypertension, dyslipidemia, or diabetes. Following calculation of prescriptions to meet individual nutritional requirements based on the Harris Benedict equation, participants were randomized to the Campbell's Center for Nutrition and Wellness (CCNW) plan, which is composed of prepackaged breakfast, lunch, and dinner meals provided to participants, or a nutritionist-guided American Heart Association Step I and Step II diet, in which participants self-selected foods to meet their nutrition prescription for 10 weeks. Main Outcome Measures: Blood pressure (BP); lipid, glucose, glycosylated hemoglobin (HbA(1c)), and insulin levels; body weight: dietary intake; and quality of life. Results: Patients' BP, lipid levels, carbohydrate metabolism, weight, and quality of life (P≤.001 for all findings except low-density lipoprotein-high-density lipoprotein ratio, P=.25) all improved on both nutrition plans. Mean differences (±SD) between baseline and treatment clinical values for the CCNW and the self-selected diet groups (between-group P values), respectively, were as follows: systolic BP, -6.4±9.2 mm Hg and -4.6±9.0 mm Hg (P=.02); diastolic BP, -4.2±5.7 mm Hg and -3.0±5.1 mm Hg (P=.006); cholesterol, -0.32±0.58 mmol/L and - 0.27±0.56 mmol/L (-12.4±22.5 mg/dL and -10.4±21.9 mg/dL) (P=.30); glucose, -0.65±1.88 mmol/L and -0.75±2.03 mmol/L (-11.7±34.0 mg/dL and -13.5±36.6 mg/dL) (P=.10); and HbA(1c), -0.4%±0.8% and 0.3%±0.7% (P=.66). Weight loss with the CCNW and self-selected plans, respectively, was as follows: men, - 4.5±3.6 kg and 3.5±3.3 kg; and women, -4.8±3.0 kg and -2.8±2.8 kg. Quality of life was significantly improved for daily and work activities (P<.05) and nutritional health perceptions (P<.05) with the CCNW plan relative to the self-selected group. Overall nutrient intake and compliance were both significantly (P<.001) better with the CCNW plan. Conclusions: Nutritionally balanced meals that meet the recommendations of national health organizations improved multiple risk factors for patients with cardiovascular disease. The CCNW plan resulted in greater clinical benefits, nutritional completeness, and compliance than the self-selected diet. The CCNW is a comprehensive nutrition plan, convenient for both prescription anti practice, and appears viable for effecting favorable dietary changes in patients at high risk for cardiovascular disease.

Original languageEnglish (US)
Pages (from-to)169-177
Number of pages9
JournalArchives of Internal Medicine
Volume157
Issue number2
StatePublished - 1997

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Fitness Centers
Randomized Controlled Trials
Blood Pressure
Meals
Diet
Prescriptions
Quality of Life
Food
Compliance
Cardiovascular Diseases
Lipids
Glucose
Recommended Dietary Allowances
Nutrition Policy
Nutritional Requirements
Lunch
Breakfast
Nutritionists
Health
Glycosylated Hemoglobin A

ASJC Scopus subject areas

  • Internal Medicine

Cite this

McCarron, D. A., Oparil, S., Chait, A., Haynes, R. B., Kris-Etherton, P., Stern, J. S., ... Pi-Sunyer, F. X. (1997). Nutritional management of cardiovascular risk factors: A randomized clinical trial. Archives of Internal Medicine, 157(2), 169-177.

Nutritional management of cardiovascular risk factors : A randomized clinical trial. / McCarron, David A.; Oparil, Suzanne; Chait, Alan; Haynes, R. Brian; Kris-Etherton, Penny; Stern, Judith S.; Resnick, Lawrence M.; Clark, Sharon; Morris, Cynthia D.; Hatton, Daniel C.; Metz, Jill A.; McMahon, Margaret; Holcomb, Scott; Snyder, Geoffrey W.; Pi-Sunyer, F. Xavier.

In: Archives of Internal Medicine, Vol. 157, No. 2, 1997, p. 169-177.

Research output: Contribution to journalArticle

McCarron, DA, Oparil, S, Chait, A, Haynes, RB, Kris-Etherton, P, Stern, JS, Resnick, LM, Clark, S, Morris, CD, Hatton, DC, Metz, JA, McMahon, M, Holcomb, S, Snyder, GW & Pi-Sunyer, FX 1997, 'Nutritional management of cardiovascular risk factors: A randomized clinical trial', Archives of Internal Medicine, vol. 157, no. 2, pp. 169-177.
McCarron DA, Oparil S, Chait A, Haynes RB, Kris-Etherton P, Stern JS et al. Nutritional management of cardiovascular risk factors: A randomized clinical trial. Archives of Internal Medicine. 1997;157(2):169-177.
McCarron, David A. ; Oparil, Suzanne ; Chait, Alan ; Haynes, R. Brian ; Kris-Etherton, Penny ; Stern, Judith S. ; Resnick, Lawrence M. ; Clark, Sharon ; Morris, Cynthia D. ; Hatton, Daniel C. ; Metz, Jill A. ; McMahon, Margaret ; Holcomb, Scott ; Snyder, Geoffrey W. ; Pi-Sunyer, F. Xavier. / Nutritional management of cardiovascular risk factors : A randomized clinical trial. In: Archives of Internal Medicine. 1997 ; Vol. 157, No. 2. pp. 169-177.
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abstract = "Background: Adherence to dietary recommendations for disease management is often hindered by the complexity of incorporating them into the daily diet. Nutrition and cardiovascular scientists anti food technologists collaborated to develop a prepared meal plan that meets national dietary guidelines for cardiovascular risk reduction. Objective: To assess the clinical effects of this plan, which incorporates all National Academy of Sciences National Research Council recommended dietary allowances for vitamins, minerals, and macronutrients, compared with a patient-selected American Heart Association Step I anti Step II diet plan. Methods: This multicenter, randomized, parallel-intervention trial was conducted at 10 medical centers in the United States and Canada and involved 560 men and women with hypertension, dyslipidemia, or diabetes. Following calculation of prescriptions to meet individual nutritional requirements based on the Harris Benedict equation, participants were randomized to the Campbell's Center for Nutrition and Wellness (CCNW) plan, which is composed of prepackaged breakfast, lunch, and dinner meals provided to participants, or a nutritionist-guided American Heart Association Step I and Step II diet, in which participants self-selected foods to meet their nutrition prescription for 10 weeks. Main Outcome Measures: Blood pressure (BP); lipid, glucose, glycosylated hemoglobin (HbA(1c)), and insulin levels; body weight: dietary intake; and quality of life. Results: Patients' BP, lipid levels, carbohydrate metabolism, weight, and quality of life (P≤.001 for all findings except low-density lipoprotein-high-density lipoprotein ratio, P=.25) all improved on both nutrition plans. Mean differences (±SD) between baseline and treatment clinical values for the CCNW and the self-selected diet groups (between-group P values), respectively, were as follows: systolic BP, -6.4±9.2 mm Hg and -4.6±9.0 mm Hg (P=.02); diastolic BP, -4.2±5.7 mm Hg and -3.0±5.1 mm Hg (P=.006); cholesterol, -0.32±0.58 mmol/L and - 0.27±0.56 mmol/L (-12.4±22.5 mg/dL and -10.4±21.9 mg/dL) (P=.30); glucose, -0.65±1.88 mmol/L and -0.75±2.03 mmol/L (-11.7±34.0 mg/dL and -13.5±36.6 mg/dL) (P=.10); and HbA(1c), -0.4{\%}±0.8{\%} and 0.3{\%}±0.7{\%} (P=.66). Weight loss with the CCNW and self-selected plans, respectively, was as follows: men, - 4.5±3.6 kg and 3.5±3.3 kg; and women, -4.8±3.0 kg and -2.8±2.8 kg. Quality of life was significantly improved for daily and work activities (P<.05) and nutritional health perceptions (P<.05) with the CCNW plan relative to the self-selected group. Overall nutrient intake and compliance were both significantly (P<.001) better with the CCNW plan. Conclusions: Nutritionally balanced meals that meet the recommendations of national health organizations improved multiple risk factors for patients with cardiovascular disease. The CCNW plan resulted in greater clinical benefits, nutritional completeness, and compliance than the self-selected diet. The CCNW is a comprehensive nutrition plan, convenient for both prescription anti practice, and appears viable for effecting favorable dietary changes in patients at high risk for cardiovascular disease.",
author = "McCarron, {David A.} and Suzanne Oparil and Alan Chait and Haynes, {R. Brian} and Penny Kris-Etherton and Stern, {Judith S.} and Resnick, {Lawrence M.} and Sharon Clark and Morris, {Cynthia D.} and Hatton, {Daniel C.} and Metz, {Jill A.} and Margaret McMahon and Scott Holcomb and Snyder, {Geoffrey W.} and Pi-Sunyer, {F. Xavier}",
year = "1997",
language = "English (US)",
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TY - JOUR

T1 - Nutritional management of cardiovascular risk factors

T2 - A randomized clinical trial

AU - McCarron, David A.

AU - Oparil, Suzanne

AU - Chait, Alan

AU - Haynes, R. Brian

AU - Kris-Etherton, Penny

AU - Stern, Judith S.

AU - Resnick, Lawrence M.

AU - Clark, Sharon

AU - Morris, Cynthia D.

AU - Hatton, Daniel C.

AU - Metz, Jill A.

AU - McMahon, Margaret

AU - Holcomb, Scott

AU - Snyder, Geoffrey W.

AU - Pi-Sunyer, F. Xavier

PY - 1997

Y1 - 1997

N2 - Background: Adherence to dietary recommendations for disease management is often hindered by the complexity of incorporating them into the daily diet. Nutrition and cardiovascular scientists anti food technologists collaborated to develop a prepared meal plan that meets national dietary guidelines for cardiovascular risk reduction. Objective: To assess the clinical effects of this plan, which incorporates all National Academy of Sciences National Research Council recommended dietary allowances for vitamins, minerals, and macronutrients, compared with a patient-selected American Heart Association Step I anti Step II diet plan. Methods: This multicenter, randomized, parallel-intervention trial was conducted at 10 medical centers in the United States and Canada and involved 560 men and women with hypertension, dyslipidemia, or diabetes. Following calculation of prescriptions to meet individual nutritional requirements based on the Harris Benedict equation, participants were randomized to the Campbell's Center for Nutrition and Wellness (CCNW) plan, which is composed of prepackaged breakfast, lunch, and dinner meals provided to participants, or a nutritionist-guided American Heart Association Step I and Step II diet, in which participants self-selected foods to meet their nutrition prescription for 10 weeks. Main Outcome Measures: Blood pressure (BP); lipid, glucose, glycosylated hemoglobin (HbA(1c)), and insulin levels; body weight: dietary intake; and quality of life. Results: Patients' BP, lipid levels, carbohydrate metabolism, weight, and quality of life (P≤.001 for all findings except low-density lipoprotein-high-density lipoprotein ratio, P=.25) all improved on both nutrition plans. Mean differences (±SD) between baseline and treatment clinical values for the CCNW and the self-selected diet groups (between-group P values), respectively, were as follows: systolic BP, -6.4±9.2 mm Hg and -4.6±9.0 mm Hg (P=.02); diastolic BP, -4.2±5.7 mm Hg and -3.0±5.1 mm Hg (P=.006); cholesterol, -0.32±0.58 mmol/L and - 0.27±0.56 mmol/L (-12.4±22.5 mg/dL and -10.4±21.9 mg/dL) (P=.30); glucose, -0.65±1.88 mmol/L and -0.75±2.03 mmol/L (-11.7±34.0 mg/dL and -13.5±36.6 mg/dL) (P=.10); and HbA(1c), -0.4%±0.8% and 0.3%±0.7% (P=.66). Weight loss with the CCNW and self-selected plans, respectively, was as follows: men, - 4.5±3.6 kg and 3.5±3.3 kg; and women, -4.8±3.0 kg and -2.8±2.8 kg. Quality of life was significantly improved for daily and work activities (P<.05) and nutritional health perceptions (P<.05) with the CCNW plan relative to the self-selected group. Overall nutrient intake and compliance were both significantly (P<.001) better with the CCNW plan. Conclusions: Nutritionally balanced meals that meet the recommendations of national health organizations improved multiple risk factors for patients with cardiovascular disease. The CCNW plan resulted in greater clinical benefits, nutritional completeness, and compliance than the self-selected diet. The CCNW is a comprehensive nutrition plan, convenient for both prescription anti practice, and appears viable for effecting favorable dietary changes in patients at high risk for cardiovascular disease.

AB - Background: Adherence to dietary recommendations for disease management is often hindered by the complexity of incorporating them into the daily diet. Nutrition and cardiovascular scientists anti food technologists collaborated to develop a prepared meal plan that meets national dietary guidelines for cardiovascular risk reduction. Objective: To assess the clinical effects of this plan, which incorporates all National Academy of Sciences National Research Council recommended dietary allowances for vitamins, minerals, and macronutrients, compared with a patient-selected American Heart Association Step I anti Step II diet plan. Methods: This multicenter, randomized, parallel-intervention trial was conducted at 10 medical centers in the United States and Canada and involved 560 men and women with hypertension, dyslipidemia, or diabetes. Following calculation of prescriptions to meet individual nutritional requirements based on the Harris Benedict equation, participants were randomized to the Campbell's Center for Nutrition and Wellness (CCNW) plan, which is composed of prepackaged breakfast, lunch, and dinner meals provided to participants, or a nutritionist-guided American Heart Association Step I and Step II diet, in which participants self-selected foods to meet their nutrition prescription for 10 weeks. Main Outcome Measures: Blood pressure (BP); lipid, glucose, glycosylated hemoglobin (HbA(1c)), and insulin levels; body weight: dietary intake; and quality of life. Results: Patients' BP, lipid levels, carbohydrate metabolism, weight, and quality of life (P≤.001 for all findings except low-density lipoprotein-high-density lipoprotein ratio, P=.25) all improved on both nutrition plans. Mean differences (±SD) between baseline and treatment clinical values for the CCNW and the self-selected diet groups (between-group P values), respectively, were as follows: systolic BP, -6.4±9.2 mm Hg and -4.6±9.0 mm Hg (P=.02); diastolic BP, -4.2±5.7 mm Hg and -3.0±5.1 mm Hg (P=.006); cholesterol, -0.32±0.58 mmol/L and - 0.27±0.56 mmol/L (-12.4±22.5 mg/dL and -10.4±21.9 mg/dL) (P=.30); glucose, -0.65±1.88 mmol/L and -0.75±2.03 mmol/L (-11.7±34.0 mg/dL and -13.5±36.6 mg/dL) (P=.10); and HbA(1c), -0.4%±0.8% and 0.3%±0.7% (P=.66). Weight loss with the CCNW and self-selected plans, respectively, was as follows: men, - 4.5±3.6 kg and 3.5±3.3 kg; and women, -4.8±3.0 kg and -2.8±2.8 kg. Quality of life was significantly improved for daily and work activities (P<.05) and nutritional health perceptions (P<.05) with the CCNW plan relative to the self-selected group. Overall nutrient intake and compliance were both significantly (P<.001) better with the CCNW plan. Conclusions: Nutritionally balanced meals that meet the recommendations of national health organizations improved multiple risk factors for patients with cardiovascular disease. The CCNW plan resulted in greater clinical benefits, nutritional completeness, and compliance than the self-selected diet. The CCNW is a comprehensive nutrition plan, convenient for both prescription anti practice, and appears viable for effecting favorable dietary changes in patients at high risk for cardiovascular disease.

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