HyperglycemiaNCT02702934
Metabolic Effects of High-amylose Wheat-based Rusks.
A study testing Test meal in people with Hyperglycemia, run by Federico II University at 1 site in Italy.
Trial summary
Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Feb 2016
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight/obese;
- 30-60 years.
Who cannot join
- age <30 and >60 years;
- fasting triglycerides ≥400 mg/dl;
- fasting cholesterol >270 mg/dl;
- cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
- established diabetes mellitus or any chronic disease;
- renal and liver failure (creatinine >1.7 mg/dl and transaminases >2 times than normal values, respectively);
- anaemia (Hb <12 g /dl);
- any chronic disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.
Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.
- Conditions
- Hyperglycemia
- Being tested
- Test meal
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealOther
Also called Acute test meal
Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.
| Study group | Role | What they receive |
|---|---|---|
| High-amylose rusks | Experimental | Test meal with 100g of carbohydrates coming from high-amylose rusks Receives: Other: Test meal |
| Control rusks | Active comparator | Test meal with 100g of carbohydrates coming from regular rusks used as control Receives: Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Incremental area under the curve
Measured: 4 hours
Secondary outcomes (3)
Blood insulin
Incremental area under the curve
Measured: 4 hours
Intestinal fermentation
Incremental area under the curve
Measured: 4 hours
Blood triglycerides
Incremental area under the curve
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMay 2015
- Primary completionOct 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rivellese angela, Federico II University
- Investigators
- Angela Rivellese, Professor, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702934
- Sponsor's protocol ID
- 233/14
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of High-amylose Wheat-based Rusks in Healthy Subjects. A Pilot Study.
- ClinicalTrials.gov ID
- NCT02702934
- Acronym / sponsor ID
- 233/14
- Conditions
- Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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.
Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based rusks in overweight subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-amylose rusks | Experimental | Other: Test mealTest meal with 100g of carbohydrates coming from high-amylose rusks |
| Control rusks | Active comparator | Other: Test mealTest meal with 100g of carbohydrates coming from regular rusks used as control |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Overweight/obese;
- 30-60 years.
Key exclusion criteria (8 listed)
- age <30 and >60 years;
- fasting triglycerides ≥400 mg/dl;
- fasting cholesterol >270 mg/dl;
- cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
- established diabetes mellitus or any chronic disease;
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 |
|---|---|---|
| Test mealAlso: Acute test mealParticipants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations. | Other | Control rusks, High-amylose rusks |
Primary outcome
Blood glucose
Time frame: 4 hours
Incremental area under the curve
3 secondary outcomes
Blood insulin
Time frame: 4 hours
Intestinal fermentation
Time frame: 4 hours
Blood triglycerides
Time frame: 4 hours
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 10 Aug 2017.
- 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.
Angela Rivellese, Professor principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test meal in people with Hyperglycemia, run by Federico II University at 1 site in Italy.
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 2 inclusion and 8 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 10 Aug 2017. 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 Italy. 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?
Blood glucose (time frame: 4 hours). 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 10 Aug 2017.