Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers

Agricultural University of Athens

Status: Completed

Conditions: Hypertension; Prediabetes; Dyslipidemias; Overweight and Obesity

Treatments: Other: Conventional orange juice; Other: Orange juice enriched with vitamin D3 and encapsulated probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06114576

HRPD 75/04.10.2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Orange juice enriched with vitamin D3 and encapsulated probiotics

Experimental group

Description:

250 ml of orange juice enriched with vitamin D3 and encapsulated probiotics

Treatment:

Other: Orange juice enriched with vitamin D3 and encapsulated probiotics

Conventional orange juice

Active Comparator group

Description:

250 ml of conventional orange juice

Treatment:

Other: Conventional orange juice