NCT06114576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 18, 2023

Last Update Submit

October 27, 2023

Conditions

Overweight and ObesityPrediabetesHypertensionDyslipidemias

Keywords

orange juicevitamin D3probioticscardiometabolic risk factors

Outcome Measures

Primary Outcomes (1)

  • Change in blood glucose concentrations

    Clinically significant change in blood glucose concentrations (mg/dL)

    8 weeks

Secondary Outcomes (7)

  • Change in energy intake

    8 weeks

  • Change in blood lipids

    8 weeks

  • Change in blood insulin concentrations

    8 weeks

  • Change in basal metabolic rate (BMR)

    8 weeks

  • Change in central aortic blood pressure

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Orange juice enriched with vitamin D3 and encapsulated probiotics

EXPERIMENTAL

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

Other: Orange juice enriched with vitamin D3 and encapsulated probiotics

Conventional orange juice

ACTIVE COMPARATOR

250 ml of conventional orange juice

Other: Conventional orange juice

Interventions

Orange juice enriched with vitamin D3 and encapsulated probioticsOTHER

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.

Orange juice enriched with vitamin D3 and encapsulated probiotics
Conventional orange juiceOTHER

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.

Conventional orange juice

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[total cholesterol \> 200 mg/dL, and/or LDL-C \> 100 mg/dL, and/or triglycerides \> 150 mg/dL\]

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agricultural University of Athens

Athens, Attica, 11855, Greece

Location

MeSH Terms

Conditions

OverweightObesityPrediabetic StateHypertensionDyslipidemias

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Emilia Papakonstantinou, PhD

    Agricultural University of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 18, 2023

First Posted

November 2, 2023

Study Start

March 1, 2023

Primary Completion

July 25, 2023

Study Completion

August 30, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)