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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemias; Overweight and Obesity; Prediabetes
• Intervention / Treatment: Other: Orange juice enriched with vitamin D3 and encapsulated probiotics; Other: Conventional orange juice

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11855
      • Agricultural University of Athens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orange juice enriched with vitamin D3 and encapsulated probiotics; 250 ml of orange juice enriched with vitamin D3 and encapsulated probiotics	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.
Active Comparator: Conventional orange juice; 250 ml of conventional orange juice	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood glucose concentrations	Clinically significant change in blood glucose concentrations (mg/dL)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in energy intake	Clinically significant change in energy intake (kcal/day)	8 weeks
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
Change in blood insulin concentrations	Clinically significant change in blood insulin concentrations (μU/L)	8 weeks
Change in basal metabolic rate (BMR)	Clinically significant change in basal metabolic rate (kcal/day)	8 weeks
Change in central aortic blood pressure	Clinically significant change in central pressure (mmHg)	8 weeks
Change in body weight	Clinically significant change in body weight (kg)	8 weeks

Collaborators and Investigators

• Sponsor: Agricultural University of Athens
• Investigators: Principal Investigator: Emilia Papakonstantinou, PhD, Agricultural University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): August 30, 2023

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 27, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: probiotics; vitamin D3; orange juice; cardiometabolic risk factors
• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Dyslipidemias; Overweight; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: HRPD 75/04.10.2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No