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

NCT06057389 | Unknown

• 1 other identifier: I-23PJ329
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Obesity

Outcome Measures

Primary Outcomes (14)

• gut microbiota

  High flux sequencing of fecal specimens

  8 weeks

• glucose metabolism

  Fasting blood glucose (in mmol/L)

  8 weeks

• glucose metabolism

  fasting insulin (in μIU/L)

  8 weeks

• glucose metabolism

  glycosylated hemoglobin (in %)

  8 weeks

• lipid metabolism

  total cholesterol (in mmol/L)

  8 weeks

• lipid metabolism

  triglycerides (in mmol/L)

  8 weeks

• lipid metabolism

  high-density lipoprotein cholesterol (in mmol/L)

  8 weeks

• lipid metabolism

  low-density lipoprotein cholesterol (in mmol/L)

  8 weeks

• leptin

  serum leptin (in ng/ml)

  8 weeks

• adiponectin

  serum adiponectin (in μg/ml)

  8 weeks

• Inflammatory cytokine

  serum interleukin-1 (in pg/mL)

  8 weeks

• Inflammatory cytokine

  serum interleukin-6 (in ng/L)

  8 weeks

• Inflammatory cytokine

  tumor necrosis factor-α (in pg/ml)

  8 weeks

• Inflammatory cytokine

  hypersensitive C-reactive protein (in mg/L)

  8 weeks

Secondary Outcomes (4)

• Anthropometrics

  8 weeks

• Anthropometrics

  8 weeks

• Anthropometrics

  8 weeks

• body composition

  8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention group: an energy-restricted diet + aronia melanocarpa extract

Dietary Supplement: aronia melanocarpa extract

Control group

PLACEBO COMPARATOR

control group: an energy-restricted diet + maltodextrin

Dietary Supplement: aronia melanocarpa extract

Interventions

aronia melanocarpa extract DIETARY_SUPPLEMENT

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

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 28, 2023
• Study Start: October 7, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09