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

September 21, 2023 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Intervention group: an energy-restricted diet + aronia melanocarpa extract
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
Placebo Comparator: Control group
control group: an energy-restricted diet + maltodextrin
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gut microbiota
Time Frame: 8 weeks
High flux sequencing of fecal specimens
8 weeks
glucose metabolism
Time Frame: 8 weeks
Fasting blood glucose (in mmol/L)
8 weeks
glucose metabolism
Time Frame: 8 weeks
fasting insulin (in μIU/L)
8 weeks
glucose metabolism
Time Frame: 8 weeks
glycosylated hemoglobin (in %)
8 weeks
lipid metabolism
Time Frame: 8 weeks
total cholesterol (in mmol/L)
8 weeks
lipid metabolism
Time Frame: 8 weeks
triglycerides (in mmol/L)
8 weeks
lipid metabolism
Time Frame: 8 weeks
high-density lipoprotein cholesterol (in mmol/L)
8 weeks
lipid metabolism
Time Frame: 8 weeks
low-density lipoprotein cholesterol (in mmol/L)
8 weeks
leptin
Time Frame: 8 weeks
serum leptin (in ng/ml)
8 weeks
adiponectin
Time Frame: 8 weeks
serum adiponectin (in μg/ml)
8 weeks
Inflammatory cytokine
Time Frame: 8 weeks
serum interleukin-1 (in pg/mL)
8 weeks
Inflammatory cytokine
Time Frame: 8 weeks
serum interleukin-6 (in ng/L)
8 weeks
Inflammatory cytokine
Time Frame: 8 weeks
tumor necrosis factor-α (in pg/ml)
8 weeks
Inflammatory cytokine
Time Frame: 8 weeks
hypersensitive C-reactive protein (in mg/L)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometrics
Time Frame: 8 weeks
Body weight (in kg)
8 weeks
Anthropometrics
Time Frame: 8 weeks
waist circumference (in cm)
8 weeks
Anthropometrics
Time Frame: 8 weeks
BMI in kg/m^2
8 weeks
body composition
Time Frame: 8 weeks
including body fat (in %), fat-free mass (in kg)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 7, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • I-23PJ329

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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