Dyslipidemias, Hypertension, Overweight and Obesity, Prediabetes
Conditions
Keywords
orange juice, vitamin D3, probiotics, cardiometabolic risk factors
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.
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.
Interventions
OTHEROrange 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.
OTHERConventional 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.
Sponsors
Agricultural University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood glucose concentrations | 8 weeks | Clinically significant change in blood glucose concentrations (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 energy intake | 8 weeks | Clinically significant change in energy intake (kcal/day) |
| 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 |
| Change in central aortic blood pressure | 8 weeks | Clinically significant change in central pressure (mmHg) |
Countries
Greece
Outcome results
None listed