Type 1 diabetes mellitus (DMT-1) is a metabolic disorder, mainly of autoimmune origin, characterized by hyperglycemia (where the level of sugar in blood is too high) caused by a lack of insulin secretion.
The possibilities of saffron in the treatment of hyperlipidemia, hypertension, atherosclerosis, and myocardial damage have been highlighted in experimental studies, systematic reviews and meta-analyses. But the authors of the current study said there have been several low-quality clinical trials on this topic.
Probiotics have shown promising results in improving metabolic health, especially in reducing body weight, fasting blood glucose, HbA1c, and insulin in people with DMT2.
The aim of the new randomized, double-blind placebo-controlled study was to evaluate the effectiveness of extract of a probiotic with Crocus sativus L. on metabolic control in people with DMT-1 using glucose monitoring systems.
"To our knowledge, this is the first double-blind, randomized clinical trial investigating the impact of Crocus sativus L. extract in people with DMT-1," explained the authors from Aristotle University of Thessaloniki and University General Hospital of Thessaloniki AHEPA, Greece.
Because saffron is not marketed in Greece as a stand-alone supplement but only in combination with probiotics and prebiotics, the researchers decided to use the combination supplement LactoLevure ProbioMood, supplied by Uni-Pharma Greece.
Their findings demonstrated that the administration of the supplement over a period of six months significantly enhanced glycemic control and reduced triglyceride (a type of fat in the blood) levels in individuals with well-controlled DMT-1.
"These findings suggest that the incorporation of saffron extract into the treatment plan of people with DMT-1 could provide additional benefits to standard treatment, enhancing and improving overall metabolic health that is essential to these individuals," they concluded.
The study
The researchers recruited 61 individuals with DMT-1 (mean age 48 years old, 26 females) and randomized them to receive an oral supplement in sachets containing probiotics, prebiotics, magnesium, and Crocus sativus L. extract or placebo for six months.
They assessed glycemic control at baseline and at the end of intervention with a continuous glucose monitoring system. Other measurements included physical activity level, HbA1c and lipid profile, and blood pressure.
Diabetes distress and satiety were assessed through a questionnaire and body composition was assessed with bioelectrical impedance.
Resulting data revealed that at the end of the intervention the two groups differed significantly in serum triglycerides. In the active group, after six months of treatment, glycated hemoglobin was significantly reduced, as well as serum triglycerides.
Diabetes distress score improved significantly only in the active group, suggesting an overall improvement in diabetes disease burden in these individuals, but this was not significantly different between the two groups.
They reported a key strength of their study was the six-month intervention period. However, they noted collected glucose monitoring data reflected only two weeks’ glycemic control at baseline and end of intervention. Presumably, collecting data for a longer period of time would be more efficient in understanding and confirming the improvement in glycemic control demonstrated with the HbA1c, they said. Further, variables could have been better controlled with dietary intake documentation throughout the six month period.
"We can consider that the improvement in glycated hemoglobin, serum triglycerides, and diabetes distress score observed in the intervention group is mainly due to the intake of the supplement," the authors concluded. "Glycemia, reported by CGM data, did not demonstrate any difference within or between the two groups at baseline and at the end of the intervention. However, CGM data represent only two weeks’ glycemic control at baseline and end of intervention and may not fully reflect HbA1c values."
"Future research should focus on evolving delivery of the saffron bioactives through supplements and developing supplements with a higher proportion of these bioactives," the report stated. "Also, more randomized controlled studies with a more extended period of time need to be conducted in individuals with either DMT-1 or DMT-2 to explore the full potential and safety of saffron supplementation in DM."
Mechanisms
Saffron is said to decrease systolic blood pressure through its vasomodulating effects and anti-inflammatory effects, according to the authors of the current study. Its hypotensive effects can be attributed to the blocking of calcium channels and possible interaction with endothelial nitric oxide (NO).
One possible lipid-lowering mechanism is through the reduction of lipid peroxidation factors such as malondialdehyde (MDA) by increasing the action and expression of antioxidant enzymes, preventing phosphorylation of certain protein kinases and reducing the production of reactive oxygen species (ROS).
Another possible mechanism is via regulation of the expression of growth factors such as tumor necrosis factor-α, adiponectin, and leptin in adipose tissue or fat mass.
One of the possible mechanisms of the beneficial action of saffron in metabolic control is the antioxidant aspect. Evidence in experimental studies shows that crocin can reduce oxidative stress by decreasing MDA and increasing glutathione.
Also, saffron can increase glucose uptake into cells, improving insulin signaling and increasing glucose transporter type 4 (GLUT-4) into the cell membranes.
Source: Nutrients
https://doi.org/10.3390/nu16132089 (registering DOI)
"Effect of Crocus sativus Extract Supplementation in the Metabolic Control of People with Diabetes Mellitus Type 1: A Double-Blind Randomized Placebo-Controlled Trial"
Authors: Giannoulaki, P.; Kotzakioulafi, E.; Nakas, A.; Kontoninas, Z.; Karlafti, E.; Evripidou, P.; Kantartzis, K.; Savopoulos, C.; Chourdakis, M.; Didangelos, T.