Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06114576
• Other study ID #: HRPD 75/04.10.2022
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Agricultural University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 30, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Body Mass Index >= 25 kg/m2

• Prediabetes [fasting blood glucose > 100 mg/dL], or/and

• Hypertension [Systolic blood pressure (SBP) > 130 mmHg or Diastolic blood pressure (DBP) > 80 mmHg], or/and

• Hyperlipidemia [total cholesterol > 200 mg/dL, and/or LDL-C > 100 mg/dL, and/or triglycerides > 150 mg/dL]

Exclusion Criteria:

• Severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver diseases, endocrine conditions)

• Medication that affects glycemia such as metformin, glucocorticoids, thiazide diuretics

• Gastrointestinal disorders

• Pregnancy

• Lactation

• Alcohol abuse

• Drug dependency

• Body weight lowering medications and/or history of bariatric surgery

• Depression and other psychiatric diseases

• Cancer

• Probiotic, prebiotic, and vitamin D supplemental intake

Related Conditions & MeSH terms

• Dyslipidemias
• Hypertension
• Overweight
• Overweight and Obesity
• Prediabetes

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Agricultural University of Athens	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Agricultural University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood glucose concentrations	Clinically significant change in blood glucose concentrations (mg/dL)	8 weeks
Secondary	Change in energy intake	Clinically significant change in energy intake (kcal/day)	8 weeks
Secondary	Change in blood lipids	Clinically significant in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL), and high-density lipoprotein (mg/dL)	8 weeks
Secondary	Change in blood insulin concentrations	Clinically significant change in blood insulin concentrations (µU/L)	8 weeks
Secondary	Change in basal metabolic rate (BMR)	Clinically significant change in basal metabolic rate (kcal/day)	8 weeks
Secondary	Change in central aortic blood pressure	Clinically significant change in central pressure (mmHg)	8 weeks
Secondary	Change in body weight	Clinically significant change in body weight (kg)	8 weeks
Secondary	Change in gut microbiome	The microbial composition in fecal samples will be measured via taxonomic profiling by 16S (V3-V4 region) ribosomal RNA gene amplicon sequencing using the MiSeq Illumina platform (v3 300bp pair-end sequencing) to identify a wide diversity of microbes	8 weeks