Overweight and ObesityNCT03986775
Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension
A study testing isomaltulose and sucrose in people with Overweight and Obesity, run by Beneo-Institute.
Trial summary
To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- isomaltulose and sucrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 9 Aug 2017
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is healthy at the time of pre-examination
- Subject has a BMI of 25 - 35 kg/m²
- Subject is aged 25 - 50 years at the time of pre-examination
- Signed written informed consent
- Inactive (IPAQ score <1)
- Waist to Hip ratio ≥0.90 cm for males, ≥0.85 cm for females
- High-normo/Mild hypertensive (SBP: 130-159 mmHg / DBP: 80-99 mmHg)
Who cannot join
- Use of medication interfering with RAAS, such as ACE-inhibitors,
- Advanced cardio-vascular disease (CVD),
- Severe kidney disorders (CKD),
- Diabetes mellitus, both type 1 and II diabetes,
- Pregnant, lactating or wish to become pregnant,
- Hypersensitivity to any of the components of the test product,
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- Restricted diet (vegetarian)
- Thyroid disease
- Heavy Smokers (light smokers allowed)
- Lack of suitability for participation in the trial, for any medical reason, as judged by the PI.
- Excessive alcohol consumption (>21 units/week for males \& >14 units/week for females)
About this study
Official title: AFCRO-066: A Double-blinded, Randomized, Controlled, Acute, Cross-over Study to Determine the Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension
To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension.
- Conditions
- Overweight and Obesity
- Being tested
- isomaltulose, sucrose
- Keywords
- Glycemic Index, Overweight, Endothelial function, carbohydrate
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isomaltuloseDietary supplement
replacement of sucrose with low-glycemic isomaltulose
sucroseDietary supplement
conventional beverage with sucrose
| Study group | Role | What they receive |
|---|---|---|
| citrus drink with isomaltulose | Active comparator | Not described Receives: Dietary Supplement: isomaltulose |
| citrus drink with sucrose | Placebo comparator | Not described Receives: Dietary Supplement: sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial ultrasound FMD scan
Changes in postprandial flow-mediated Dilation (endothelial function)
Measured: Baseline, 60 minutes, 120 minutes, 180 minutes
Secondary outcomes (2)
Postprandial glycemic response
Postprandial glycemic response (Plasma samples)
Measured: Baseline, 60 minutes, 120 minutes, 180 minutes
Postprandial insulin response
Postprandial Insulin response (Plasma samples)
Measured: Baseline, 60 minutes, 120 minutes, 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Aug 2016
- Primary completion3 Mar 2017
- Study completion9 Aug 2017
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986775
- Sponsor's protocol ID
- AFCRO-066
- Status last verified
- Jun 2019
- First submitted
- 11 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AFCRO-066: A Double-blinded, Randomized, Controlled, Acute, Cross-over Study to Determine the Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension
- ClinicalTrials.gov ID
- NCT03986775
- Acronym / sponsor ID
- AFCRO-066
- Conditions
- Overweight and Obesity
- Keywords
- Glycemic Index, Overweight, Endothelial function, carbohydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 14 Jun 2019 (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.
To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| citrus drink with isomaltulose | Active comparator | Dietary Supplement: isomaltulose |
| citrus drink with sucrose | Placebo comparator | Dietary Supplement: sucrose |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is healthy at the time of pre-examination
- Subject has a BMI of 25 - 35 kg/m²
- Subject is aged 25 - 50 years at the time of pre-examination
- Signed written informed consent
- Inactive (IPAQ score <1)
Key exclusion criteria (11 listed)
- Use of medication interfering with RAAS, such as ACE-inhibitors,
- Advanced cardio-vascular disease (CVD),
- Severe kidney disorders (CKD),
- Diabetes mellitus, both type 1 and II diabetes,
- Pregnant, lactating or wish to become pregnant,
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 |
|---|---|---|
| isomaltulosereplacement of sucrose with low-glycemic isomaltulose | Dietary supplement | citrus drink with isomaltulose |
| sucroseconventional beverage with sucrose | Dietary supplement | citrus drink with sucrose |
Primary outcome
Brachial ultrasound FMD scan
Time frame: Baseline, 60 minutes, 120 minutes, 180 minutes
Changes in postprandial flow-mediated Dilation (endothelial function)
2 secondary outcomes
Postprandial glycemic response
Time frame: Baseline, 60 minutes, 120 minutes, 180 minutes
Postprandial insulin response
Time frame: Baseline, 60 minutes, 120 minutes, 180 minutes
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 17 Jun 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing isomaltulose and sucrose in people with Overweight and Obesity, run by Beneo-Institute.
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 7 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Brachial ultrasound FMD scan (time frame: Baseline, 60 minutes, 120 minutes, 180 minutes). 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 17 Jun 2019.