Dietary advice and oral nutritional supplements do not increase survival in older malnourished adults: a multicentre randomised controlled trial

Figures & data

Figure 1. Flow chart describing the participant recruitment and randomisation process in five hospitals in central Sweden. DA: dietary advice; MNA: Mini Nutritional Assessment; MNA SF: MNA Short Form; ONS: oral nutritional supplements; SPMSQ: Short Portable Mental Status Questionnaire.

Table 1. Dietary advice given to participants based on the answers from the mini nutritional assessment instrument.

	Advice aiming at improving …				Other	Advice regarding …
MNA question with low scores	Energy density^a	Nutrient density^b	Texture of food	Number of meals per day^c	Advice to relatives	How to complete meals	Protein-dense foods	Increased vegetable or fruit intake	Increased fluid intake
Declined food intake	✓	✓	✓	✓
Recent weight loss	✓		✓	✓
Mobility					✓
Neuropsychological problems					✓
Body mass index	✓			✓
Living independently					✓
Number of full meals						✓
Protein intake							✓
Vegetable intake								✓
Fluid intake									✓
Mode of feeding					✓
Mid arm circumference	✓		✓
Calf circumference	✓	✓	✓

^aEnergy density: dietary advice regarding energy supplementation with energy-dense food, e.g., butter, margarine, full-fat dairy products (milk/yoghurt/cream), oil, and sugar. Beverages should be energy-dense.

^bNutrient density: improved content of protein, vitamins, and minerals in meals.

^cNumber of meals per day: the energy and nutrient content should be distributed into 3 main meals and 1–3 in-between meals. The overnight fast should not exceed 11 h.

Table 2. Characteristics of the 671 participants at baseline.

	DA	ONS	DA and ONS	Control
	(n = 168)	(n = 170)	(n = 169)	(n = 164)
Variables
Malnourished, %	24.4	24.7	24.9	24.4
Age, y – mean (SD)	79.9 (7.9)	77.6 (7.5)	79.0 (7.6)	78.2 (7.7)
Women, %	58.3	65.9	58.6	61.6
Body mass index, kg/m^2 – mean (SD)^a	23.7 (3.8)	24.2 (4.2)	23.8 (4.1)	23.7 (4.2)
Smoking, %
Never smoker	47.3	44.1	42.6	43.9
Former smoker	43.7	47.1	45.0	46.3
Current smoker	9.0	8.8	12.4	9.8
Living alone, %	55.1	44.7	49.1	49.4
Length of overnight fast, h – mean (SD)	12.4 (1.9)	12.5 (1.9)	12.3 (1.8)	12.3 (2.0)
Cooks independently, %
Always	42.5	39.4	43.8	45.7
Sometimes	44.3	46.5	45.6	40.2
Never	13.2	14.1	10.7	14.0
Receiving home care service, %	31.3	22.6	27.2	17.8
Charlson Comorbidity Index – mean (SD)	1.2 (1.4)	1.4 (1.8)	1.3 (1.6)	1.5 (1.8)
Number of medications – mean (SD)	6.9 (3.7)	6.9 (3.7)	6.9 (3.8)	6.7 (3.7)

All characteristics except survival rate are as per baseline in 2010–2014.

^aTwo participants had a BMI ≥35 kg/m².

DA: dietary advice; ONS: oral nutritional supplements; SD: standard deviation.

Figure 2. Kaplan–Meier survival curves for participants in the four intervention groups (n = 671). Log-rank test for any difference between groups (p = 0.762). DA: dietary advice; ONS: oral nutritional supplements.

Figure 3. Kaplan–Meier survival curves for participants at risk of malnutrition in the four intervention groups (n = 506). Log-rank test for any difference between groups (p = 0.480). DA: dietary advice; ONS: oral nutritional supplements.

Figure 4. Kaplan–Meier survival curves for malnourished participants in the four intervention groups (n = 165). Log-rank test for any difference between groups (p = 0.298). DA: dietary advice; ONS: oral nutritional supplements.

Table 3. All-cause mortality for the three interventions and the control group.

Nutritional status	Intervention	Unadjusted HR (95% CI)^a	p Value	Adjusted HR (95% CI)^b	p Value
All participants	DA	1.16 (0.88–1.53)	0.296	1.21 (0.83–1.75)	0.317
	ONS	1.05 (0.79–1.39)	0.749	1.08 (0.73–1.60)	0.691
	DA + ONS	1.08 (0.81–1.43)	0.603	1.08 (0.74–1.56)	0.693
	Control	1.00^c		1.00^c
At risk of malnutrition	DA	1.24 (0.89–1.72)	0.201	1.20 (0.83–1.74)	0.342
	ONS	1.11 (0.79–1.55)	0.553	1.08 (0.73–1.60)	0.688
	DA + ONS	0.98 (0.70–1.39)	0.929	1.08 (0.74–1.56)	0.691
	Control	1.00^c		1.00^c
Malnourished	DA	0.97 (0.58–1.64)	0.918	1.01 (0.53–1.92)	0.984
	ONS	0.90 (0.53–1.52)	0.686	1.22 (0.64–2.33)	0.538
	DA + ONS	1.39 (0.85–2.29)	0.193	1.03 (0.53–2.01)	0.931
	Control	1.00^c		1.00^c

Results of separate Cox regression analyses for the participants at risk of malnutrition and the malnourished participants, respectively.

^aResults based on 506 (100.0%) participants at risk of malnutrition and 165 (100.0%) malnourished participants.

^bAdjusted for age, sex, body mass index, smoking, living alone, length of overnight fast, cooks independently, receiving home care service, Charlson Comorbidity Index, and number of medications. Age is included as piecewise with change point at 731 days of follow-up for both nutritional status groups, as are smoking, cooks independently, and number of medications for the malnourished group. For the total group, age is included as piecewise with change points at 731 and 1461 days of follow-up. The results are based on 423 (83.6%) participants at risk of malnutrition and 125 (75.8%) malnourished participants with complete values for all variables.

^cReference category.

DA: dietary advice; HR: hazard ratio; ONS: oral nutritional supplements.