A single center, prospective, single arm, interventional, open labelled, pilot study to understand the efficacy of the intake of oyster mushroom-based soup mix for plasma glucose control in pre diabetic patients

Diabetes Mellitus is a metabolic disorder where the intrinsic glucose control of the body is disturbed and therefore the regulation on how body converts food into energy is lost. It is a chronic disease and there are millions of people who are living with the disease. Mushroom derived functional foods and dietary supplements with bioactive compounds have been shown to help towards the treatment, management, and prevention of the type 2 diabetes. Many mechanistic views for this process has been proposed such as slow breakdown of polysaccharides, inhibition of enzymes amylase and glucosidase, increase in beta cell proliferation, decreased absorption of carbohydrates, increase in glycogen synthesis, increase in insulin signaling etc., towards alleviation of symptoms of Type 2 diabetes. For many of the edible mushroom varieties there are many proven health benefits and one of them is their anti-diabetic potential.

A initial pilot study was conducted using the product “Mushroom Delight” in 10 patients, the results showed a decrease in fasting blood glucose and post prandial levels in patients who are newly or pre diabetic.

This study will provide a systematic analysis and have a control set where the benefit due to the mushroom soup can be quantified and analyzed.

Study Rationale:Understand the capability of the formulated oyster mushroom mix soup to effectively control the blood sugar levels.

Objectives of the study is to evaluate impact of study product on HbA1c, blood sugar level, lipid profile levels.

Inclusion Criteria for the study includes Patients of all genders, age group 18 to 60 years, with HbA1c level between 5.8% and 6.4%. The participants must be drug-naive diabetics (i.e., those who have not previously received any pharmacological treatment for diabetes) or diabetics who are not currently on any oral hypoglycemic agents (OHA). patients who are willing to not take the medication during the study period..

Exclusion Criteria includes Patients with HbA1C less than 5.8% and more than 6.4%. Patients who are prescribed medications for sugar control. Pregnant and lactating women, patients with untreated thyroid disease. Patients with any use of or has a history of drug and/or alcohol abuse. Patients with psychiatric or mental disorders

Withdrawal criteria for study is Patient will be withdrawn if the sugar levels increase dramatically, and the patient is suggested by the doctor to be on medication. Patients who have allergy to mushrooms and have gastrointestinal trouble due to the consumption of mushroom soup.

Blood investigation for study Fasting blood glucose levels (FBG),   HbA1C levels,Post prandial glucose concentrations,Lipid profile

The patient will visit the hospital in following time point during which the above mentioned blood test will be performed: Visit 2 (Day 45 ± 7) and a)    Visit 3_End of the treatment (Day 90 ± 7)

Data parameters for study: Demographic details, Type of diet  (Vegetarian/Non Vegetarian/  Eggetarian/ Vegan), Physical Assessment (Height, Weight, BP), Fasting blood glucose levels (FBG), HbA1C levels, Post prandial glucose concentrations, Lipid profile.Duration of the study is 3 months.

Endpoints of the study is to evaluate the changes in HbA1c and lipid level of the patients post consumption of mushroom oyster soup. To evaluate the changes in lifestyle behavior of the patients post consumption of mushroom oyster soup.