NCT06114576

Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers

Effects of Orange Juice Enriched With Vitamin D3 and Encapsulated Probiotics in High Cardiometabolic Risk Individuals

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Agricultural University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The effects of orange juice enriched with vitamin D3 and encapsulated probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) compared to conventional orange juice on several cardiometabolic and anthropometric parameters in individuals at risk of cardiovascular disease.

Detailed description

This randomized, double-blind, controlled clinical trial aims to evaluate the effects of the consumption of orange juice enriched with vitamin D3 and encapsulated probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) compared to conventional orange juice in 50 high cardiometabolic risk volunteers. The participants must be overweight/obese with either prediabetes, and/or hypertension, and/or hyperlipidemia, and will be divided and randomly assigned into 2 groups of 25 individuals each. Participants will consume 250 ml of either orange juice enriched with vitamin D3 and encapsulated probiotics (Lacticaseibacillus casei Shirota and Lacticaseibacillus rhamnosus GG) or conventional orange juice daily for 8 weeks as an addition to their usual dietary intake. Participants will be asked to maintain their usual physical activity during the intervention period. At the beginning of the study and at 8 weeks, blood samples will be collected after 12 hours of fasting. Two-hour oral glucose tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the beginning and at 8 weeks. Anthropometric measurements will be performed at the beginning and every week for 8 weeks. Basal metabolic rate (BMR) and central aortic blood pressure will be measured at the beginning, 4 weeks, and 8 weeks of intervention. Fecal samples will be collected and analyzed to study gut microbiome compositob at the intervention's beginning and at 8 weeks.

Conditions

• Overweight and Obesity
• Prediabetes
• Hypertension
• Dyslipidemias

Interventions

Type	Name	Description
OTHER	Orange juice enriched with vitamin D3 and encapsulated probiotics	25 high cardiometabolic risk volunteers will be asked to consume 250 ml orange juice enriched with 2000 IU vitamin D3 and 10\^8 cfu/ml encapsulated probiotics (Lactocaseibacillus casei shirota and Lactocaseibacillus rhamnosus GG) daily, for 8 weeks, without any other change in their dietary habits and physical activity.
OTHER	Conventional orange juice	25 high cardiometabolic risk volunteers will be asked to consume 250 ml conventional orange juice daily, for 8 weeks, without any other change in their dietary habits and physical activity.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-07-25
• Completion: 2023-08-30
• First posted: 2023-11-02
• Last updated: 2023-11-02

Locations

1 site across 1 country: Greece