The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential

NCT06435130 | Completed

• 1 other identifier: MUBialystok2
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Keywords

chokeberry; juice; fiber; diet; intervention; diabetes; obesity; hypertension; hypercholesterolemia

Outcome Measures

Primary Outcomes (7)

• Change in waist circumference

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in waist circumference was observed.

  12 weeks

• Change in blood pressure

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in systolic and diastolic blood pressure was observed.

  12 weeks

• Change in glycated hemoglobin

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glycated hemoglobin was observed.

  12 weeks

• Change in glucose level

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in glucose level was observed.

  12 weeks

• Change in LDL-cholesterol

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in LDL-cholesterol level was observed.

  12 weeks

• Change in aspartate transaminase (AST) level

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in aspartate transaminase (AST) level was observed.

  12 weeks

• Change in antioxidant potential of serum

  After 8 weeks of using chokeberry juice-100 mL daily and another 4 weeks of using chokeberry juice - 100 mL daily and chokeberry fiber - 10 g daily, a change in antioxidant potential of serum was observed.

  12 weeks

Study Arms (1)

Dietary intervention with chokeberry juice and fibre

EXPERIMENTAL

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.

Other: Dietary intervention with chokeberry juices; Other: Dietary intervention with chokeberry juices and fibers

Interventions

Dietary intervention with chokeberry juices 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 juice and fibre

Dietary intervention with chokeberry juices and fibers 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.

Dietary intervention with chokeberry juice and fibre

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Bialystok: lead

Study Sites (1)

Medical University of Bialystok

Bialystok, 15-089, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Obesity; Hypercholesterolemia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Malgorzata E. Zujko, Dr.

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 102 people (67 women and 35 men) with metabolic disorders were included in the interventional study

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: May 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

PL (1)