The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential

NCT ID: NCT06435130

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-08-30

Brief Summary

Chokeberry can be used both in the prevention and treatment of various metabolic disorders due to its high antioxidant properties. The study assessed for the first time the synergistic effect of chokeberry juice and chokeberry fiber on selected metabolic and anthropometric parameters. 102 people (67 women and 35 men) took part in the intervention study. After 8 weeks of intervention with chokeberry juice and another 4 weeks of intervention with chokeberry juice and fiber, a change in waist circumference, blood pressure, glucose, glycated hemoglobin, LDL cholesterol, aspartate transaminase (AST) and the level of antioxidant potential was observed.

Conditions

Diet, Healthy; Diabetes Mellitus; Hypertension; Obesity; Hypercholesterolemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Dietary intervention with chokeberry juice and fibre

Study participants consumed 100 mL of chokeberry juice daily for 8 weeks. After 8 weeks, participants consumed 100 ml of chokeberry juice and 10 g of chokeberry fiber daily for 4 weeks.

Group Type: EXPERIMENTAL

Dietary intervention with chokeberry juices

Intervention Type: OTHER

The first stage of the dietary intervention lasted 8 weeks. Study participants consumed 100 ml of chokeberry juice daily. Chokeberry juice came from ecological cultivation (Poland). Participants qualified for the study had specific biochemical parameters tested: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. Blood tests were performed in a certified external laboratory before and after 8 weeks of intervention. In addition, blood pressure and waist circumference were tested.

Dietary intervention with chokeberry juices and fibers

Intervention Type: OTHER

The second stage of the dietary intervention lasted 4 weeks. Study participants consumed 100 ml of chokeberry juice daily and 10 g chokeberry fiber daily (from ecological cultivation, Poland). Blood tests were performed in a certified external laboratory after 4 weeks of intervention. The following blood tests were performed: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. In addition, blood pressure and waist circumference were tested.

Interventions

Dietary intervention with chokeberry juices

The first stage of the dietary intervention lasted 8 weeks. Study participants consumed 100 ml of chokeberry juice daily. Chokeberry juice came from ecological cultivation (Poland). Participants qualified for the study had specific biochemical parameters tested: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. Blood tests were performed in a certified external laboratory before and after 8 weeks of intervention. In addition, blood pressure and waist circumference were tested.

Intervention Type: OTHER

Dietary intervention with chokeberry juices and fibers

The second stage of the dietary intervention lasted 4 weeks. Study participants consumed 100 ml of chokeberry juice daily and 10 g chokeberry fiber daily (from ecological cultivation, Poland). Blood tests were performed in a certified external laboratory after 4 weeks of intervention. The following blood tests were performed: fasting glucose and insulin level, lipid profile (triglycerides, total cholesterol, LDL-cholesterol, HDL-cholesterol), glycated hemoglobin, uric acid, C-reactive protein (CRP), creatinine, liver enzymes: alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamylotranspeptydase (GGTP), homocysteine and antioxidant potential. In addition, blood pressure and waist circumference were tested.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age 30-65 years,
• low or moderate physical activity.

Exclusion Criteria

• age <30 and >65 years,
• high physical activity,
• obesity (class II),
• diabetes (all types),
• gastric ulcer,
• acute or chronic gastritis,
• intestinal diseases, including inflammatory bowel diseases and functional intestinal disorders,
• taking hypoglycemic, lipid-lowering, immunosuppressive, anticoagulant and antihypertensive drugs, use of steroid therapy,
• high physical activity,
• pregnancy,
• breastfeeding.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Bialystok

OTHER

Sponsor Role: lead

Responsible Party

Małgorzata Zujko

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malgorzata E. Zujko, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Bialystok

Locations

Medical University of Bialystok

Bialystok, , Poland

Countries

Poland

Other Identifiers

MUBialystok2

Identifier Type: -

Identifier Source: org_study_id