Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers

Sponsor

Agricultural University of Athens (Other)

Overall Status

Completed

CT.gov ID

NCT06114576

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Prediabetes Hypertension Dyslipidemias	Other: Orange juice enriched with vitamin D3 and encapsulated probiotics Other: Conventional orange juice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Double-blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Actual Primary Completion Date :

Jul 25, 2023

Actual Study Completion Date :

Aug 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in blood glucose concentrations [8 weeks]
Clinically significant change in blood glucose concentrations (mg/dL)

Secondary Outcome Measures

Change in energy intake [8 weeks]
Clinically significant change in energy intake (kcal/day)
Change in blood lipids [8 weeks]
Clinically significant in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL), and high-density lipoprotein (mg/dL)
Change in blood insulin concentrations [8 weeks]
Clinically significant change in blood insulin concentrations (μU/L)
Change in basal metabolic rate (BMR) [8 weeks]
Clinically significant change in basal metabolic rate (kcal/day)
Change in central aortic blood pressure [8 weeks]
Clinically significant change in central pressure (mmHg)
Change in body weight [8 weeks]
Clinically significant change in body weight (kg)
Change in gut microbiome [8 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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