Overweight and ObesityNCT06114576
Effects of Biofunctional Orange Juice on Cardiometabolic Risk Markers
A study testing Orange juice enriched with vitamin D3 and encapsulated probiotics and Conventional orange juice in people with Overweight and Obesity and Prediabetes, run by Agricultural University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight and Obesity, Prediabetes, Hypertension
- What is being tested?
- Orange juice enriched with vitamin D3 and encapsulated probiotics and Conventional orange juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2023to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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]
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Orange Juice Enriched With Vitamin D3 and Encapsulated Probiotics in High Cardiometabolic Risk Individuals
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.
Read the 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.
- Conditions
- Overweight and Obesity, Prediabetes, Hypertension, Dyslipidemias
- Being tested
- Orange juice enriched with vitamin D3 and encapsulated probiotics, Conventional orange juice
- Keywords
- orange juice, vitamin D3, probiotics, cardiometabolic risk factors
- Medical subject headings
- Overweight, Obesity, Prediabetic State, Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Orange juice enriched with vitamin D3 and encapsulated probiotics | Experimental | 250 ml of orange juice enriched with vitamin D3 and encapsulated probiotics Receives: Other: Orange juice enriched with vitamin D3 and encapsulated probiotics |
| Conventional orange juice | Active comparator | 250 ml of conventional orange juice Receives: Other: Conventional orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose concentrations
Clinically significant change in blood glucose concentrations (mg/dL)
Measured: 8 weeks
Secondary outcomes (7)
Change in energy intake
Clinically significant change in energy intake (kcal/day)
Measured: 8 weeks
Change in blood lipids
Clinically significant in triglycerides (mg/dL), total cholesterol (mg/dL), low-density lipoprotein (mg/dL), and high-density lipoprotein (mg/dL)
Measured: 8 weeks
Change in blood insulin concentrations
Clinically significant change in blood insulin concentrations (μU/L)
Measured: 8 weeks
Change in basal metabolic rate (BMR)
Clinically significant change in basal metabolic rate (kcal/day)
Measured: 8 weeks
Change in central aortic blood pressure
Clinically significant change in central pressure (mmHg)
Measured: 8 weeks
Change in body weight
Clinically significant change in body weight (kg)
Measured: 8 weeks
Change in gut microbiome
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Mar 2023
- Primary completion25 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimilia Papakonstantinou, Agricultural University of Athens
- Investigators
- Emilia Papakonstantinou, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114576
- Sponsor's protocol ID
- HRPD 75/04.10.2022
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Orange Juice Enriched With Vitamin D3 and Encapsulated Probiotics in High Cardiometabolic Risk Individuals
- ClinicalTrials.gov ID
- NCT06114576
- Acronym / sponsor ID
- HRPD 75/04.10.2022
- Conditions
- Overweight and Obesity, Prediabetes, Hypertension, Dyslipidemias
- Keywords
- orange juice, vitamin D3, probiotics, cardiometabolic risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange juice enriched with vitamin D3 and encapsulated probiotics | Experimental | Other: Orange juice enriched with vitamin D3 and encapsulated probiotics250 ml of orange juice enriched with vitamin D3 and encapsulated probiotics |
| Conventional orange juice | Active comparator | Other: Conventional orange juice250 ml of conventional orange juice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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]
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juice enriched with vitamin D3 and encapsulated probiotics25 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. | Other | Orange juice enriched with vitamin D3 and encapsulated probiotics |
| Conventional orange juice25 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. | Other | Conventional orange juice |
Primary outcome
Change in blood glucose concentrations
Time frame: 8 weeks
Clinically significant change in blood glucose concentrations (mg/dL)
7 secondary outcomes
Change in energy intake
Time frame: 8 weeks
Change in blood lipids
Time frame: 8 weeks
Change in blood insulin concentrations
Time frame: 8 weeks
Change in basal metabolic rate (BMR)
Time frame: 8 weeks
Change in central aortic blood pressure
Time frame: 8 weeks
Change in body weight
Time frame: 8 weeks
Change in gut microbiome
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Papakonstantinou, PhD principal investigator
Agricultural University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice enriched with vitamin D3 and encapsulated probiotics and Conventional orange juice in people with Overweight and Obesity and Prediabetes, run by Agricultural University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood glucose concentrations (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.