The Effects of Aronia Melanocarpa Extract on Obese Individuals With Impaired Fasting Blood Glucose

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effects of a natural supplement called Aronia melanocarpa extract, also known as Aronia berries, on people who are obese and have slightly high blood sugar levels. The study aims to find out if taking this extract, along with a reduced-calorie diet, can help improve health markers like weight, blood sugar, and fat levels, as well as support gut health. Participants will be divided into two groups: one will take the Aronia extract while following the diet, and the other will take a placebo (a harmless substance that looks like the extract) along with the same diet.

To be eligible for the trial, participants need to be between 18 and 40 years old, have a body mass index (BMI) indicating obesity, and have specific blood sugar levels that are not high enough to be diagnosed as diabetes. Over the course of eight weeks, both groups will have their blood and stool samples tested before and after the study to see how their bodies respond. This trial is not currently recruiting participants, but it aims to provide valuable information about the potential health benefits of Aronia berries for managing obesity and related health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18-40 years
• • Simple obese individuals with stable body weight in the last three months before enrollment (28.0kg/m2 ≤ BMI \<35.0kg/m2)
• • Impaired fasting blood glucose: Within the last three months before enrollment, the venous fasting blood glucose was between 6.1 and 7.0 mmol/L, and the 2-hour postprandial blood glucose was\<7.8 mmol/L and the glycated hemoglobin (HbA1c) was \< 6.5%
• Exclusion Criteria:
• • Diagnosed patients with diabetes or those who use hypoglycemic drugs
• • Patients with concomitant hyperthyroidism or hypothyroidism, or those taking thyroxine tablets
• • Those who apply glucocorticoids within 12 weeks
• • Individuals with suspected renal dysfunction (female: serum creatinine ≥ 84 µ mol/L; male: serum creatinine ≥ 104 µ mol/L) or suspected liver dysfunction (elevated transaminase \>3 times normal or cirrhosis)
• • Secondary obesity (such as thalamic diseases, pituitary diseases, Cushing's syndrome, etc.)
• • Previous weight loss surgeries
• • Pregnant or lactating individuals
• • Individuals with confirmed mental illness or eating disorders
• • Women with polycystic ovary syndrome
• • Individuals who are allergic or intolerant to experimental products
• • Lactose intolerant individuals
• • Those who have taken probiotics and/or probiotic drugs or supplements within one month before enrollment
• • Those who fail to use intervention agents according to the study protocol or have severely incomplete visit records