Postprandial HyperglycemiaNCT03899974
Metabolic Effects of High-amylose Wheat-based Breads
A study testing Test meal in people with Postprandial Hyperglycemia, run by Federico II University at 1 site in Italy.
Trial summary
The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postprandial Hyperglycemia
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 31 Jul 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese
- 18-70 years
Who cannot join
- age <18 and >70 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals
The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.
- Conditions
- Postprandial 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
Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) 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.
After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the "second meal effect" from breakfast to lunch.
| Study group | Role | What they receive |
|---|---|---|
| 70% amylose bread | Experimental | Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour) Receives: Other: Test meal |
| 85% amylose bread | Experimental | Mixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour) Receives: Other: Test meal |
| Control bread | Active comparator | Mixed meal with 80g of available carbohydrates coming mainly from conventional bread Receives: Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-hours blood glucose response
incremental area under the curve
Measured: over 2 hours after the test meal
Secondary outcomes (5)
2-hours blood insulin response
incremental area under the curve
Measured: over 2 hours after the test meal
4-hours blood glucose response
incremental area under the curve
Measured: over 4 hours after the test meal
4-hours blood insulin response
incremental area under the curve
Measured: over 4 hours after the test meal
intestinal fermentation
breath test for the detection of hydrogen production
Measured: over 4 hours after the test meal
glucose response
Second meal effect
Measured: over 2 hours after the standard meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Mar 2018
- Primary completion15 Dec 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postprandial 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899974
- Sponsor's protocol ID
- 252/17
- Status last verified
- Dec 2019
- First submitted
- 29 Mar 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Costabile G, Vetrani C, Calabrese I, Vitale M, Cipriano P, Salamone D, Testa R, Paparo L, Russo R, Rivellese AA, Giacco R, Riccardi G. High Amylose Wheat Bread at Breakfast Increases Plasma Propionate Concentrations and Reduces the Postprandial Insulin Response to the Following Meal in Overweight Adults. J Nutr. 2023 Jan;153(1):131-137. doi: 10.1016/j.tjnut.2022.10.007. Epub 2022 Dec 20.
PubMed 36913446
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals
- ClinicalTrials.gov ID
- NCT03899974
- Acronym / sponsor ID
- 252/17
- Conditions
- Postprandial Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 2 Apr 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.
The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 70% amylose bread | Experimental | Other: Test mealMixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 70% high-amylose flour) |
| 85% amylose bread | Experimental | Other: Test mealMixed meal with 80g of available carbohydrates coming mainly from high-amylose bread (made with 85% high-amylose flour) |
| Control bread | Active comparator | Other: Test mealMixed meal with 80g of available carbohydrates coming mainly from conventional bread |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight/obese
- 18-70 years
Key exclusion criteria (7 listed)
- age <18 and >70 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 mealParticipants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) 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. After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the "second meal effect" from breakfast to lunch. | Other | 70% amylose bread, 85% amylose bread, Control bread |
Primary outcome
2-hours blood glucose response
Time frame: over 2 hours after the test meal
incremental area under the curve
5 secondary outcomes
2-hours blood insulin response
Time frame: over 2 hours after the test meal
4-hours blood glucose response
Time frame: over 4 hours after the test meal
4-hours blood insulin response
Time frame: over 4 hours after the test meal
intestinal fermentation
Time frame: over 4 hours after the test meal
glucose response
Time frame: over 2 hours after the standard meal
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 4 Dec 2019.
- Derived from this study: PubMed 36913446Costabile G, Vetrani C, Calabrese I, Vitale M, Cipriano P, Salamone D, Testa R, Paparo L, Russo R, Rivellese AA, Giacco R, Riccardi G. High Amylose Wheat Bread at Breakfast Increases Plasma Propionate Concentrations and Reduces the Postprandial Insulin Response to the Following Meal in Overweight Adults. J Nutr. 2023 Jan;153(1):131-137. doi: 10.1016/j.tjnut.2022.10.007. Epub 2022 Dec 20.
- 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.
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 Postprandial 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 7 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 4 Dec 2019. 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?
2-hours blood glucose response (time frame: over 2 hours after the test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899974, which also lists 1 linked publication.
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 4 Dec 2019.