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Completed

NCT Number: NCT06435130

The Impact of Chokeberry Bioproducts on Metabolic Parameters and Antioxidant Potential

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.

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Key information

Conditions

Diet, Healthy Body Weight Cardiovascular Diseases Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Bialystok

Bialystok, 15-089, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Change in waist circumference

    Time frame: 12 weeks

    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.

  2. Change in blood pressure

    Time frame: 12 weeks

    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.

  3. Change in glycated hemoglobin

    Time frame: 12 weeks

    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.

  4. Change in glucose level

    Time frame: 12 weeks

    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.

  5. Change in LDL-cholesterol

    Time frame: 12 weeks

    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.

  6. Change in aspartate transaminase (AST) level

    Time frame: 12 weeks

    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.

  7. Change in antioxidant potential of serum

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Medical University of Bialystok

Other

Registry information

Official study title

The Impact of Chokeberry Bioproducts Consumption on Metabolic Parameters and the Antioxidant Potential of Serum

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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