Effects of long-term consumption of two plant-based dietary supplements on cardiovascular health and low-grade inflammation in middle-aged and elderly people: study protocol for a randomised, controlled trial

Table 2 Detailed summary of primary, secondary and tertiary outcome parameters

Primary outcomes	Low-grade inflammation
Cardiovascular health
Total cholesterol, LDL, HDL, ApoA1, TG, oxLDL, homocysteine, omega-3 Index, platelet aggregation, TEM, coagulation (PT, PTT), glucose, insulin, HOMA-IR, HbA1c, MDA, CP, redox state of albumin	TNF-α, sTNFR1 and sTNFR2, CCL5, IL-1β, hsCRP, CCL2, OPG, IL-5, IL-8

Secondary outcomes	Upper respiratory tract symptoms	Quality of life
Selected indicators of ageing
uc-osteocalcin, dp-ucMGP, mtDNA-CN, BDNF, NGF, CFD index	WURSS-21	SF-36

Tertiary outcomes	Fatty acids
Vitamins and carotenoids
Retinol, vitamins C, D, E (α-tocopherol and γ- tocopherol), K1, K2 (MK-7), α-carotene, β-carotene, lutein, zeaxanthin, lycopene, β-cryptoxanthin	DHA, DPA, EPA, AA, ALA, linoleic acid, oleic acid, palmitoleic acid, stearic acid

AA arachidonic acid, ALA alpha-linolenic acid, ApoA1 apolipoprotein A1, BDNF brain-derived neurotropic factor, CCL2 chemokine (C–C motif) ligand 2, CCL5 chemokine (C–C motif) ligand 5, CFD index cognitive functions dementia index, CP carbonyl proteins, DHA docosahexaenoic acid, DPA docosapentaenoic acid, dp-ucMGP dephosphorylated-uncarboxylated Matrix GLA protein, EPA eicosapentaenoic acid, HbA1c haemoglobin A1c, HDL high-density lipoprotein, HOMA-IR homeostatic model assessment of insulin resistance, hsCRP high-sensitivity C-reactive protein, IL-1β interleukin 1-beta, IL-5 Interleukin-5, IL-8 interleukin-8, LDL low-density lipoprotein, MDA malondialdehyde, mtDNA-CN mitochondrial DNA copy number, NGF nerve growth factor, OPG osteoprotegerin, oxLDL oxidised low-density lipoprotein, PT prothrombin time, PTT partial thromboplastin time, SF-36 36-Item Short Form Health Survey, sTNFR1 soluble tumour necrosis factor receptor 1, sTNFR2 soluble tumour necrosis factor receptor 2, TEM thrombelastometry, TG triglycerides, TNF-α tumour necrosis factor alpha, uc-osteocalcin undercarboxylated osteocalcin, WURSS-21 Wisconsin upper respiratory symptom survey

ISSN: 2072-1315