No evidence of hypoglycemia or hypotension in older adults during 6 months of flax lignan supplementation in a randomized controlled trial: A safety evaluation

Figures & data

Table 1. Baseline characteristics of participants.

Treatment	Age	n (M, F)	Age (y)	Weight (kg)	Height (cm)	BMI (kg/m^2)
Placebo	<65	33 (12, 21)	58.1 (4.0)	82.8 (14.5)	168 (9)	29.6 (5.5)
Lignan	<65	36 (14, 22)	58.2 (3.6)	78.5 (16.5)	168 (9)	27.7 (4.6)
	p value	0.83^a	0.91^b	0.26^b	0.88^b	0.13^b
Placebo	≥65	13 (6, 7)	71.6 (6.9)	80.1 (16.5)	169 (7)	27.9 (4.3)
Lignan	≥65	13 (7, 6)	67.6 (2.3)	79.1 (15.4)	169 (9)	27.5 (3.6)
	p value	0.69^a	0.067^b	0.87^b	0.96^b	0.78^b

M, males; F, Females. All values are means (SD).

^aChi-square test comparing counts in Treatment × Sex categories within an age category.

^bT-test comparisons between Placebo and Lignan groups within an age category.

Table 2. Blood glucose, SBP, and DBP by treatment group, age category, and time point.

				Unadjusted means (SD)
Outcome	Treatment	Age	n (M, F)	Baseline	6 months	Range
Glucose (mmol/L)	Placebo	<65	33 (12, 21)	5.3 (0.4)	5.3 (0.4)	4.7–6.3
	Lignan	<65	35 (14, 21)	5.2 (0.6)	5.3 (0.5)	4.3–6.9
			p value	0.67	0.63
	Placebo	≥65	13 (6, 7)	5.6 (0.6)	5.5 (0.6)	4.4–6.5
	Lignan	≥65	13 (7, 6)	5.6 (0.9)	5.6 (1.1)	4.8–9.1^a
			p value	0.80	0.71
SBP (mm Hg)	Placebo	<65	33 (12, 21)	127 (13)	126 (17)	92–179
	Lignan	<65	36 (14, 22)	128 (11)	126 (11)	96–146
			p value	0.76	0.87
	Placebo	≥65	12 (6, 6)	126 (18)	125 (16)	96–154
	Lignan	≥65	12 (7, 5)	128 (9)	132 (13)	112–154
			p value	0.73	0.17
DBP (mm Hg)	Placebo	<65	33 (12, 21)	82 (7)	82 (9)	62–110
	Lignan	<65	36 (14, 22)	83 (7)	81 (7)	66–98
			p value	0.64	0.83
	Placebo	≥65	12 (6, 6)	74 (9)	74 (10)	60–88
	Lignan	≥65	12 (7, 5)	81 (8)	81 (8)	65–92
			p value	0.050	0.077

M, males; F, Females; p values are generated from T-test comparisons between Placebo and Lignan groups within an age category (<65 or ≥65 years) and time point (Baseline or 6 months).

^aOne participant was observed to have an elevated glucose concentration of 9.1 mmol/L. The range of glucose concentration was 4.8–6.9 mmol/L without the outlying participant. All statistics presented were generated with the outlying participant included in the analysis.

Table 3. Adjusted glucose, SBP, and DBP by treatment group, age category, and time point.

				Adjusted means (SD)^a
Outcome	Treatment	Age	n (M, F)	Baseline	6 Months	Fixed effects	p Value
Glucose	Placebo	<65	33 (12, 21)	5.3 (0.2)	5.3 (0.2)	Treatment	0.73
	Lignan	<65	35 (14, 21)	5.3 (0.2)	5.3 (0.2)	Time	0.62
	Placebo	≥65	13 (6, 7)	5.5 (0.2)	5.5 (0.2)	Age	0.24
	Lignan	≥65	13 (7, 6)	5.6 (0.2)	5.7 (0.2)	Treatment × Age	0.76
						Treatment × Time	0.18
SBP	Placebo	<65	33 (12, 21)	127 (4)	126 (4)	Treatment	0.62
	Lignan	<65	36 (14, 22)	127 (5)	127 (4)	Time	0.46
	Placebo	≥65	12 (6, 6)	126 (5)	125 (5)	Age	1.00
	Lignan	≥65	12 (7, 5)	130 (4)	130 (4)	Treatment × Age	0.70
						Treatment × Time	0.52
DBP^b	Placebo	<65	33 (12, 21)	82 (2)	82 (2)	Treatment	0.43
	Lignan	<65	36 (14, 22)	83 (2)	81 (2)	Time	0.73
	Placebo	≥65	12 (6, 6)	74 (3)	74 (3)	Age	0.0023
	Lignan	≥65	12 (7, 5)	82 (2)	80 (2)	Treatment × Age	0.095
						Treatment × Time	0.41

^aAdjusted for sex and BMI.

^bAge main effect (the DBP of participants ≥65 years was, on average, 7.5 ± 2.4 mm Hg lower than participants <65 years; p = 0.0023; reported as mean ± SD).