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

Obesity Clinical Trial

Official title:

The Effects of Black Aronia Melanocarpa Extract Combined With a Energy-restricted Diet on Metabolic Indicators and Intestinal Microecology in Obese Individuals With Impaired Fasting Blood Glucose

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06057389
• Other study ID #: I-23PJ329
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 7, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Obesity is closely related to many chronic diseases such as hypertension, coronary heart disease, hyperlipidemia, type 2 diabetes, fatty liver, certain types of tumors, etc, which are associated with adverse health outcomes. Limiting energy intake is one of the most important treatment measures for weight loss. The fruits of Aronia melanocarpa (Aronia berries) have been found to show multiple bioactivities potentially beneficial to human health, including antidiabetic, anti-infective, antineoplastic, antiobesity, antioxidant and gut microbiota-regulating activities. Thus, it is worth investigating whether consumption of aronia melanocarpa extract have additional benefits in improving anthropometric indicators, glucose and lipid metabolism, inflammatory status, adipocyte cytokines, and intestinal microbiota in obese individuals on the basis of an energy-restricted diet.

Obese individuals will be divided into intervention group and control group in this 8-week trial. Both groups will be given an energy-restricted diet, with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group.

Fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota, glucose and lipid metabolism, inflammatory status, and adipocyte cytokines

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• aronia melanocarpa extract
aronia melanocarpa extract (each capsule contains 150 mg of anthocyanins and 30 mg of flavonoidst;twice a day,one at a time) combined with an energy-restricted diet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota	High flux sequencing of fecal specimens	8 weeks
Primary	glucose metabolism	Fasting blood glucose (in mmol/L)	8 weeks
Primary	glucose metabolism	fasting insulin (in µIU/L)	8 weeks
Primary	glucose metabolism	glycosylated hemoglobin (in %)	8 weeks
Primary	lipid metabolism	total cholesterol (in mmol/L)	8 weeks
Primary	lipid metabolism	triglycerides (in mmol/L)	8 weeks
Primary	lipid metabolism	high-density lipoprotein cholesterol (in mmol/L)	8 weeks
Primary	lipid metabolism	low-density lipoprotein cholesterol (in mmol/L)	8 weeks
Primary	leptin	serum leptin (in ng/ml)	8 weeks
Primary	adiponectin	serum adiponectin (in µg/ml)	8 weeks
Primary	Inflammatory cytokine	serum interleukin-1 (in pg/mL)	8 weeks
Primary	Inflammatory cytokine	serum interleukin-6 (in ng/L)	8 weeks
Primary	Inflammatory cytokine	tumor necrosis factor-a (in pg/ml)	8 weeks
Primary	Inflammatory cytokine	hypersensitive C-reactive protein (in mg/L)	8 weeks
Secondary	Anthropometrics	Body weight (in kg)	8 weeks
Secondary	Anthropometrics	waist circumference (in cm)	8 weeks
Secondary	Anthropometrics	BMI in kg/m^2	8 weeks
Secondary	body composition	including body fat (in %), fat-free mass (in kg)	8 weeks