Status:
COMPLETED
Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers
Lead Sponsor:
Agricultural University of Athens
Conditions:
Overweight and Obesity
Prediabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06114576
Start Date
March 1 2023
End Date
August 30 2023
Last Update
November 2 2023
Active Locations (1)
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1
Agricultural University of Athens
Athens, Attica, Greece, 11855