HealthyCrade23NCT05977543
Acute Effect of Functional Crackers on Postprandial Metabolism
A study testing Functional crackers enriched with grape seed flour and Functional crackers with 40% barley flour and enriched with β-glucans in people with Healthy, run by University of the Aegean at 1 site in Greece.
Trial summary
The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Functional crackers enriched with grape seed flour and Functional crackers with 40% barley flour and enriched with β-glucans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2023to 15 Jan 2024
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-65 years
Who cannot join
- Age over 65 years old
- History of chronic illness including type I and II diabetes (hemoglobin A1c-HbA1c > 5%)
- Abnormal Body Mass Index (BMI) (>25 kg/m2)
- Alcohol overconsumption (>40 g alcohol/day)
- Abnormal hematological and biochemical profiles (cholesterol > 6.8 mM, triglycerides > 2.8 mM, glucose > 6.11 mM)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Acute Effect of Functional Crackers, Enriched With Grape Seed Flour or With Barley Flour and β-glucans, on Postprandial Glycemic, Lipemic and Antioxidant Metabolism
The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.
Read the detailed description
A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after random allocation into the control, the grape and the barley interventional groups, received a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed the same meals, allocating in cross-over order, with 1 washout week after each trial period. Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-), Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.
- Conditions
- Healthy
- Being tested
- Functional crackers enriched with grape seed flour, Functional crackers with 40% barley flour and enriched with β-glucans
- Keywords
- enriched with 10% grape seed flour crackers, 40% barley flour crackers enriched with β-glucan, postprandial effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional crackers enriched with grape seed flourOther
Also called Grape seed flour crackers
The crackers was enriched with 10% grape seed flour
Functional crackers with 40% barley flour and enriched with β-glucansOther
Also called Barley flour crackers
The crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans.
| Study group | Role | What they receive |
|---|---|---|
| Control wheat crackers | No intervention | Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers. |
| Grape seed flour crackers | Other | Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers. Receives: Other: Functional crackers enriched with grape seed flour |
| Barley flour and β-glucan crackers | Other | Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of 60% wheat flour and 40% barley flour crackers, enriched with β-glucan Receives: Other: Functional crackers with 40% barley flour and enriched with β-glucans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Glucose concentration changes from baseline at 3hours
Measured: 3 hours
Total Antioxidant Capacity
Total Antioxidant Capacity concentration changes from baseline at 3 hours
Measured: 3 hours
Secondary outcomes (5)
Total cholesterol
Total cholesterol concentration changes from baseline at 3hours
Measured: 3 hours
High Density Lipoprotein cholesterol
High Density Lipoprotein concentration cholesterol changes from baseline at 3hours
Measured: 3 hours
Low Density Lipoprotein cholesterol
Low Density Lipoprotein cholesterol concentration changes from baseline at 3hours
Measured: 3 hours
Triglycerides
Triglycerides concentration changes from baseline at 3hours
Measured: 3 hours
Uric Acid
Uric Acid concentration changes from baseline at 3hours
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start15 Feb 2023
- Primary completion1 Oct 2023
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- On enrolment, all subjects were randomly assigned to the C: F1:F2 group (Control: Functional 1: Functional 2), to the F1: C: F2 group (Functional 1: Control: Functional 2) or to the F2: F1: C group (Functional 2: Functional 1: Control). Subjects in the C: F1:F2 group received the Control meal on the first visit, the Functional meal 1 on the second visit and the Functional meal 2 on the third visit; those in the F1:C:F2 group received the Functional meal 1 on the first visit, the Control meal on the second visit and the Functional meal 2 on the third visit while those in the F2:F1:C group received the Functional meal 2 on the first visit, the meal Functional meal 1 on the second visit and the Control meal on the third visit.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Aegean
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonios Koutelidakis, Professor, Study director, University of the Aegean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977543
- Sponsor's protocol ID
- 12123
- Acronym
- Crade23
- Status last verified
- Nov 2023
- First submitted
- 16 Jul 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data for this study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Functional Crackers, Enriched With Grape Seed Flour or With Barley Flour and β-glucans, on Postprandial Glycemic, Lipemic and Antioxidant Metabolism
- ClinicalTrials.gov ID
- NCT05977543
- Acronym / sponsor ID
- Crade23 / 12123
- Conditions
- Healthy
- Keywords
- enriched with 10% grape seed flour crackers, 40% barley flour crackers enriched with β-glucan, postprandial effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of the AegeanUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 4 Aug 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 aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.
Detailed description
A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after random allocation into the control, the grape and the barley interventional groups, received a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed the same meals, allocating in cross-over order, with 1 washout week after each trial period. Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-), Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- On enrolment, all subjects were randomly assigned to the C: F1:F2 group (Control: Functional 1: Functional 2), to the F1: C: F2 group (Functional 1: Control: Functional 2) or to the F2: F1: C group (Functional 2: Functional 1: Control). Subjects in the C: F1:F2 group received the Control meal on the first visit, the Functional meal 1 on the second visit and the Functional meal 2 on the third visit; those in the F1:C:F2 group received the Functional meal 1 on the first visit, the Control meal on the second visit and the Functional meal 2 on the third visit while those in the F2:F1:C group received the Functional meal 2 on the first visit, the meal Functional meal 1 on the second visit and the Control meal on the third visit.
| Arm | Type | Receives |
|---|---|---|
| Control wheat crackers | No intervention | –Volunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers. |
| Grape seed flour crackers | Other | Other: Functional crackers enriched with grape seed flourVolunteers consumed 80g of white bread, 30g of full fat butter and 55g of wheat flour crackers, enriched with 10% grape seed flour crackers. |
| Barley flour and β-glucan crackers | Other | Other: Functional crackers with 40% barley flour and enriched with β-glucansVolunteers consumed 80g of white bread, 30g of full fat butter and 55g of 60% wheat flour and 40% barley flour crackers, enriched with β-glucan |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 19-65 years
Key exclusion criteria (5 listed)
- Age over 65 years old
- History of chronic illness including type I and II diabetes (hemoglobin A1c-HbA1c > 5%)
- Abnormal Body Mass Index (BMI) (>25 kg/m2)
- Alcohol overconsumption (>40 g alcohol/day)
- Abnormal hematological and biochemical profiles (cholesterol > 6.8 mM, triglycerides > 2.8 mM, glucose > 6.11 mM)
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 |
|---|---|---|
| Functional crackers enriched with grape seed flourAlso: Grape seed flour crackersThe crackers was enriched with 10% grape seed flour | Other | Grape seed flour crackers |
| Functional crackers with 40% barley flour and enriched with β-glucansAlso: Barley flour crackersThe crackers consisted of 60% wheat flour, 40% barley flour and was enriched with β-glucans. | Other | Barley flour and β-glucan crackers |
Primary outcome
Glucose
Time frame: 3 hours
Glucose concentration changes from baseline at 3hours
Total Antioxidant Capacity
Time frame: 3 hours
Total Antioxidant Capacity concentration changes from baseline at 3 hours
5 secondary outcomes
Total cholesterol
Time frame: 3 hours
High Density Lipoprotein cholesterol
Time frame: 3 hours
Low Density Lipoprotein cholesterol
Time frame: 3 hours
Triglycerides
Time frame: 3 hours
Uric Acid
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data for this study.
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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.
Antonios Koutelidakis, Professor study director
University of the Aegean
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional crackers enriched with grape seed flour and Functional crackers with 40% barley flour and enriched with β-glucans in people with Healthy, run by University of the Aegean 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 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?
Results are not available in the source record.
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?
Glucose (time frame: 3 hours). The study lists 2 primary outcomes in all. 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 30 Nov 2023.