Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial

Article Figures & Data

Table 1.

Baseline Participant Characteristics

Characteristic	VLC	VLC + Support	DASH	DASH + Support
Sex, No. (%)
Male	8 (34.78)	8 (36.36)	9 (36.00)	9 (37.50)
Female	15 (65.22)	14 (63.64)	16 (64.00)	15 (62.50)
Age, y	60.09 (6.03)	55.18 (10.48)	58.40 (8.11)	60.21 (6.19)
Race/ethnicity, No. (%), can be >1
American Indian or Alaska Native	1 (4.35)	0 (0)	0 (0)	1 (4.17)
Asian/Pacific Islander	0 (0)	0 (0)	0 (0)	3 (12.50)
Black	4 (17.39)	4 (18.18)	6 (24.00)	5 (20.83)
Latine	0 (0)	2 (9.09)	1 (4.00)	1 (4.17)
White	19 (82.61)	18 (81.82)	19 (76.00)	15 (62.50)
College graduate, No. (%)	20 (86.96)	17 (77.27)	20 (80.00)	17 (70.83)
Married or long-term partner, No. (%)	21 (91.30)	17 (77.27)	20 (80.00)	18 (75.00)
Total household income, No. (%)
≤$35,000	0 (0)	1 (4.55)	3 (12.00)	3 (12.50)
$35,001-$75,000	6 (26.09)	8 (36.36)	4 (16.00)	8 (33.33)
≥$75,001	10 (43.48)	12 (54.55)	18 (72.00)	11 (45.83)
Smoker, No. (%)	0 (0)	1 (4.55)	0 (0)	1 (4.17)
SBP, mm Hg	132.53 (11.13)	133.76 (13.71)	133.13 (8.58)	131.58 (10.85)
Diastolic BP, mm Hg	85.54 (9.54)	82.98 (9)	80.82 (8.2)	82.02 (8.24)
Weight, lb	222.22 (40.53)	213.14 (31.64)	236.25 (49.61)	227.08 (42.77)
BMI, kg/m²	35.10 (5.71)	35.50 (4.69)	37.34 (6.20)	35.78 (5.42)
HbA_1c, %	6.09 (0.45)	6.13 (0.56)	6.26 (0.55)	5.99 (0.42)

BMI = body mass index; BP = blood pressure; DASH = Dietary Approaches to Stop Hypertension; HbA_1c = glycated hemoglobin; SBP = systolic blood pressure; VLC = very low-carbohydrate.
Note: Data are presented as mean (SD) unless otherwise noted.

Table 2.

Estimated Mean (SE) of Outcomes Across Diet and Time From Linear Mixed Model

Outcome	VLC Diet				DASH Diet				Difference in Change (VLC Lower)	Between- Group P Value
Outcome	Baseline	Post	Change	Within-Group P Value	Baseline	Post	Change	Within-Group P Value	Difference in Change (VLC Lower)	Between- Group P Value
SBP, mm Hg	133.72 (1.73)	123.95 (1.88)	−9.77 (1.66)	<.001	132.84 (1.69)	127.66 (1.80)	−5.18 (1.59)	.002	−4.59	.046
HbA_1c, %	6.09 (0.07)	5.74 (0.08)	−0.35 (0.07)	<.001	6.10 (0.07)	5.97 (0.07)	−0.14 (0.07)	.06	−0.21	.034
Weight, lb	219.24 (5.39)	200.10 (5.41)	−19.14 (1.73)	<.001	236.43 (5.1)	226.1 (5.2)	−10.34 (1.73)	<.001	−8.81	.0003

DASH = Dietary Approaches to Stop Hypertension; HbA_1c = glycated hemoglobin; SBP = systolic blood pressure; VLC = very low-carbohydrate.
Note: Outcomes were analyzed using a linear mixed model including all possible interactions between diet, support, and time and adjusted for age and sex. Results are presented collapsed over all other factors: support allocation, sex, and at the mean value of age. The between-group P value is calculated from a Z-test based on the estimated mean changes and the associated SE values reported in the table.

Table 3.

Beta Coefficients and SE Values From Linear Mixed Model

Parameter	Systolic BP		HbA_1c		Weight
Parameter	β Coefficient (SE)	P Value	β Coefficient (SE)	P Value	β Coefficient (SE)	P Value
Intercept	126.11 (9.23)	<.001	5.86 (0.37)	<.001	360.15 (29.96)	<.001
Baseline (vs follow-up)	8.17 (2.23)	<.001	0.16 (0.10)	.12	12.55 (2.53)	<.001
VLC (vs DASH) diet	1.99 (3.80)	.60	−0.10 (0.15)	.52	−31.91 (10.76)	<.001
No support (vs support)	7.43 (3.53)	.04	0.31 (0.14)	.03	10.19 (10.20)	.32
Time × diet	0.22 (3.35)	.95	0.23 (0.15)	.13	7.64 (3.58)	.04
Time × support	−5.97 (3.19)	.07	−0.05 (0.14)	.71	−4.43 (3.45)	.20
Diet × support	−11.40 (5.17)	.03	−0.26 (0.21)	.22	11.84 (14.99)	.43
Time × diet × support	8.73 (4.60)	.06	−0.04 (0.20)	.85	2.34 (4.89)	.63
Female (vs male)	−3.86 (2.26)	.09	0.15 (0.09)	.09	−28.50 (7.51)	<.001
Age, y	−0.004 (0.14)	.98	−0.002 (0.01)	.69	−2.12 (0.47)	<.001

BP = blood pressure; DASH = Dietary Approaches to Stop Hypertension; HbA_1c = glycated hemoglobin; VLC = very low-carbohydrate.

Table 4.

Estimated Mean (SE) of Outcomes Across Support Groups and Time From Linear Mixed Model

Outcome	Extra Support				No Extra Support				Difference in Change (Extra Lower)	Between- Group P Value
Outcome	Baseline	Post	Change	Within-Group P Value	Baseline	Post	Change	Within-Group P Value	Difference in Change (Extra Lower)	Between- Group P Value
SBP, mm Hg	133.22 (1.74)	124.94 (1.90)	−8.28 (1.68)	<.001	133.35 (1.67)	126.67 (1.78)	−6.68 (1.57)	<.001	−1.60	.49
HbA_1c, %	6.04 (0.07)	5.76 (0.08)	−0.28 (0.08)	<.001	6.15 (0.07)	5.94 (0.07)	−0.21 (0.07)	.004	−0.07	.51
Weight, lb	221.41 (5.31)	205.04 (5.36)	−16.37 (1.79)	<.001	234.26 (5.22)	221.15 (5.24)	−13.11 (1.66)	<.001	−3.26	.18

HbA_1c = glycated hemoglobin; SBP = systolic blood pressure.
Note: Outcomes were analyzed using a linear mixed model including all possible interactions between diet, support, and time and adjusted for age and sex. Results are presented collapsed over all other factors: diet, sex, and at the mean value of age. The between-group P value is calculated from a Z test based on the estimated mean changes and the associated SE values reported in the table.

Table 5.

Drug Regimen Changes for Participants Taking Drugs During Trial

BP = blood pressure; DASH = Dietary Approaches to Stop Hypertension; NA = not applicable; VLC = very low-carbohydrate.
Note: NA indicates no participants in the category.