Effects Of Saffron Supplementation On Inflammation And Metabolic Responses In Type 2 Diabetic Patients: A Randomized, Double-Blind, Placebo-Controlled Trial

Figures & data

Table 1 General Baseline Characteristics Of Subjects Who Received Either Saffron Or Placebo

Variables		Saffron Group^a	Placebo Group^b	p Value^c
Age (years)		55.2±7.3	53±10.6	0.61
Sex	Male n(%)	20 (50)	1638	0.51
	Female n(%)	20 (50)	24 (60)
Height (cm)		162±9.9	163.7±8.3	0.41
Weight (kg)		75.3±12.8	80.3±12.8	0.08
BMI (kg/m^2)		29.3±4.9	30.5±4.7	0.25
WC (cm)		106±9.5	107.8±12.9	0.75
Duration of type 2 diabetes (year)		7.8±5.4	6.6±6.1	0.13
Types of hypoglycemic drugs	Metformin n (%)	4 (10)	6 (15)	0.454
	Metformin+glibenclamide n(%)	8 (20)	13 (32.5)
	Metformin+glibenclamide+zeptin n (%)	10 (25)	8 (20)
	Other drugs n (%)	18 (45)	13 (32.5)

Notes: All quantitative values are means±SDs. All qualitative values are expressed as numbers and percentages (%). ^aReceived 100 mg saffron per day during the study. ^bReceived 100 mg placebo per day during the study. ^cObtained from independent-samples t-test for quantitative values and Chi-square for qualitative values.

Abbreviations: BMI, body mass index; WC, waist circumference.

Figure 1 Schematic diagram of the study design; individuals in the intervention group received a tablet containing 100 mg of saffron per day during the study and those in the placebo group received 100 mg maltodextrin tablet at the same time.

Table 2 Usual Dietary Intake Of Participants During The Study Who Received Either Saffron Or Placebo During The Study

Variables	Saffron Group^a	Placebo Group^b	p Value^c
Energy Intake (kcal)	1848±164	1890±160	0.608
Carbohydrate (g per day)	230.6±38.8	279.4±277.7	0.275
Protein intake (g per day)	59.4±12.5	80.2±158.5	0.411
Fat (g per day)	83.2±14.2	84.2±17.2	0.799
Vitamin A (retinol equivalent)	465±327.4	465±612.9	0.105
Vitamin E (mg per day)	32.7±45.5	24.4±5.8	0.255
Vitamin C (mg per day)	64.3±43.5	68.9±40.8	0.626
Zinc (mg per day)	12.5±33.2	7.8±1.3	0.364
Selenium (mg per day)	0.055±0.02	0.02±0.02	0.589
Beta-carotene (mg per day)	587±449	743±770	0.272

Notes: All values are mean±SD. ^aReceived 100 mg saffron per day during the study. ^bReceived 100 mg placebo per day during the study. ^cObtained from independent-samples t-test.

Table 3 Physical Activity Measurements At The Study Baseline And 12 Weeks After Intervention In Two Groups

Group	Intervention Group (Saffron)			Control Group (Maltodextrin)			p Value^b
Intensity Of PA^a Stage Of Intervention	Low	Moderate	Severe	Low	Moderate	Severe
Before intervention n (%)	24 (60)	12 (30)	4 (10)	32 (80)	5 (12.5)	3 (7.5)	0.124
After intervention n (%)	24 (60)	12 (30)	4 (10)	32 (80)	5 (12.5)	3 (7.5)	0.124

Notes: ^aPhysical activity, ^bobtained from Chi-squared test.

Table 4 Anthropometric Indices Measurement At Study Baseline And 12 Weeks After The Intervention In Subjects Who Received Either Saffron Or Placebo

Variables	Saffron Group^a		P-value^b	Placebo Group^c		P-value^b	P-value^d
	Baseline	After		Baseline	After
Body weight (kg)	75.38±12.78	74.15±12.94	<0.001	80.32±12.87	78.79±18.14	0.469	0.882
BMI (kg/m^2)	28.7±4.15	28.21±4.07	<0.001	29.91±3.91	29.27±6.57	0.449	0.861
WC (cm)	104.31±7.85	100.02±7.32	<0.001	102.95±7.94	104.33±7.42	0.048	<0.001
Body fat (%)	35.42±6.60	34.74±7.66	0.421	36.89±6.77	44.26±45.83	0.317	0.882

Notes: ^aReceived 100 mg saffron per day during study. ^bObtained from paired-samples t-test. ^cReceived 100 mg placebo per day during the study. ^dObtained from independent-samples t-test.

Abbreviations: BMI, body mass index; WC, waist circumference.

Table 5 Glycemic Indices And Lipid Profiles Measurement At Study Baseline And 12 Weeks After The Intervention In Subjects Who Received Either Saffron Or Placebo

Variables	Saffron Group^a		P-value^b	Placebo Group^c		P-value^b	P-value^d
	Baseline	After		Baseline	After
FBS (mg/dL)	166.7±53.7	162.1±52.7	0.633	160.9±51.1	147.7±51.8	0.134	0.504
HbA1c (%)	8.01±1.40	7.69±1.49	0.047	7.38±1.53	7.34±1.48	0.831	0.209
Serum insulin(pico Mol/L)	4.70±1.7	4.70±1.9	0.972	4.47±1.8	4.71±2.05	0.206	0.404
HOMA-IR	1.91±0.95	1.89±1.03	0.89	1.79±0.93	1.80±1.22	0.94	0.88
QUICKI	0.153±0.009	0.154±0.011	0.47	0.156±0.014	0.157±0.016	0.34	0.86
Triglyceride (mg/dL)	165.8±121.8	175±98.1	0.267^e	170.4±63.5	168±58.3	0.692^e	0.30^f
Total cholesterol (mg/dL)	143.7±36.6	152.8±31.4	0.029	147±32.5	155.1±37.2	0.068	0.86
LDL-C (mg/dL)	82.7±25.7	89.5±23.9	0.069	84.5±26.6	90.7±30.5	0.081	0.90
HDL-C (mg/dL)	41.8±8.4	42.2±9.4	0.732	44.35±10.1	44.9±11.3	0.676	0.91

Notes: ^aReceived 100 mg saffron per day during the study. ^bObtained from paired-samples t-test. ^cReceived 100 mg placebo per day during the study. ^dObtained from independent-samples t-test. ^eObtained from Wilcoxon signed-rank test. ^fObtained from Mann–Whitney U-test.

Abbreviations: FBS, fasting blood sugar; HbA1c, glycosylated hemoglobin; HOMA-IR, Homeostatic Model Assessment for Insulin Resistance; QUICKI, Quantitative Insulin Sensitivity Check Index; LDL-C, low-density lipoprotein-cholesterol; HDL-C, high-density lipoprotein-cholesterol.

Table 6 Inflammatory Indices, Malondialdehyde And Total Antioxidant Capacity Measurement At Study Baseline And 12 Weeks After The Intervention In Subjects Who Received Either Saffron Or Placebo

Variables	Saffron Group^a		P-value^b	Placebo Group^c		P-value^b	P-value^d
	Baseline	After		Baseline	After
TNF-α (mg/dL)	19.1±8.1	18.3±7.8	0.147	18.3±7.9	17.3±6.5	0.076	0.796
hs-CRP (mg/dL)	2.7±1.1	2.5±1	0.016	2.5±0.9	2.4±0.8	0.557	0.124
MDA (μM/L)	17.8±0.17	16.7±3.5	<0.001	15.8±2.7	15.9±2.7	0.760	0.001
TAC (μM/L)	2.04±0.7	1.98±0.6	0.03	2.11±0.6	2.1±0.6	0.273	0.230

Notes: ^aReceived 100 mg saffron per day during the study. ^bObtained from paired-samples t-test. ^cReceived 100 mg placebo per day during the study. ^dObtained from independent-samples t-test.

Abbreviations: TNF-α, tumor necrosis factor-alpha; hs-CRP, high-sensitivity C-reactive protein; MDA, malondialdehyde; TAC, total antioxidant capacity.