Nutritionally complete prepared meal plan to reduce cardiovascular risk factors: a randomized clinical trial.
OBJECTIVE
To compare a nutritionally complete prepared meal plan that meets national dietary guidelines to usual-care dietary therapy for hypertension, dyslipidemia, and glycemic control.


METHODS
Randomized, controlled trial.


METHODS
Outpatients with hypertension, dyslipidemia, or diabetes mellitus (n = 251) were recruited at 6 medical centers in the United States and Canada.


METHODS
The prepared meal plan, which was developed by university-based nutrition and cardiovascular scientists and food technologists at Campbell's Center for Nutrition & Wellness (CCNW), provided the optimal levels of macronutrients and micronutrients recommended for cardiovascular risk reduction in a variety of prepackaged meals and snacks. After a 4-week pretrial period to assess baseline state, participants were randomized to the CCNW plan or "usual-care" diet for 10 weeks.


METHODS
Blood pressure, carbohydrate metabolism, lipoproteins, homocysteine, weight, nutrient intake, compliance.


METHODS
Repeated measures analysis of variance.


RESULTS
Lipoproteins, carbohydrate metabolism, blood pressure, and weight improved on both plans. Mean differences (+/- standard deviation) between baseline and follow-up for the CCNW plan and the usual-care plan, respectively, were total cholesterol, -0.41 +/- 0.64 and -0.20 +/- 0.50 mmol/L (between-group P < .01); plasma glucose, -0.7 +/- 1.7 and -0.3 +/- 1.3 mmol/L (P < .05); systolic blood pressure, -5.2 +/- 10.0 and -4.7 +/- 9.0 mm Hg (P = .67), diastolic blood pressure, -3.8 +/- 5.9 and -2.2 +/- 5.5 mm Hg (P < .05); and homocysteine, -1.3 +/- 3.8 and 0.2 +/- 3.4 mumol/L (P < .01). The CCNW plan led to greater weight loss than the usual-care diet (-5.5 +/- 3.8 kg vs -3.0 +/- 3.2 kg, P < .0001).


CONCLUSIONS
The nutritionally complete CCNW plan offers greater improvements in lipids, blood sugars, homocysteine, and weight loss than usual-care diet therapy. This prepackaged comprehensive nutrition program can augment both the prescription and practice of optimal dietary therapy.
Haynes
R B
RB
McMaster University, Hamilton, Ontario, Canada.
Kris-Etherton
P
P
McCarron
D A
DA
Oparil
S
S
Chait
A
A
Resnick
L M
LM
Morris
C D
CD
Clark
S
S
Hatton
D C
DC
Metz
J A
JA
McMahon
M
M
Holcomb
S
S
Snyder
G W
GW
Pi-Sunyer
F X
FX
Stern
J S
JS
D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure; D002784:Cholesterol / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000178:diet therapy* / Q000517:prevention & control; D004032:Diet / Q000009:adverse effects / Q000592:standards*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006710:Homocysteine / Q000097:blood; D006801:Humans; D006949:Hyperlipidemias / Q000178:diet therapy* / Q000517:prevention & control; D006973:Hypertension / Q000178:diet therapy* / Q000517:prevention & control; D007328:Insulin / Q000097:blood; D008297:Male; D008875:Middle Aged; D009753:Nutritive Value; D010349:Patient Compliance; D012307:Risk Factors; D016896:Treatment Outcome; D015431:Weight Loss
D001786:Blood Glucose; D002784:Cholesterol; D006442:Glycated Hemoglobin; D006710:Homocysteine; D007328:Insulin