Grain-Like ProductsNCT05358561
Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals
A study testing Flaxseed and Chia in people with Grain-Like Products and Postprandial Glucose, run by Toros University at 1 site in Turkey (Türkiye).
Trial summary
This study is a pioneering study in which the effect of the consumption of cakes produced with the addition of cereal-like products such as chia and flax seeds, which have high soluble fiber content, on blood glucose and insulin values, and the effect on the satiety response of individuals after consumption of cakes… Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Grain-Like Products, Postprandial Glucose, Plasma Insulin
- What is being tested?
- Flaxseed and Chia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Sep 2022
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study will be conducted with 14 volunteers
- Aged between 19 and years 64
- No acute or chronic disease
- Body Mass Index (BMI) of 18.5-24.9 kg/m2
- Beck Depression Scale of 8 or less.
Who cannot join
- Using prescription drugs and/or fiber supplements
- Pregnant or lactating women
- Consuming excessive alcohol (> 2 drinks/day)
- Women in menstrual period
- Having allergic reaction to chia or flaxseed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özlem ÖZPAK AKKUŞ
Mersin, 33040
Özlem ÖZPAK AKKUŞ, 05051397978, dytozlemozpak@hotmail.com
About this study
Official title: An Evaluation of the Effect of Grain-Like Products on Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals
This study is a pioneering study in which the effect of the consumption of cakes produced with the addition of cereal-like products such as chia and flax seeds, which have high soluble fiber content, on blood glucose and insulin values, and the effect on the satiety response of individuals after consumption of cakes, will be a pioneer in many subjects.
As a result of the study, the relationships between the changes in the investigated parameters and the possible changes in these parameters will be revealed. The results obtained suggest that foods rich in soluble fiber such as chia and flaxseed and foods produced with the possible synergetic effect of chia and flaxseed are used in healthy and safe products suitable for our consumption habits, and that these products are both protective and protective against the development of complications such as obesity and type 2 diabetes, cardiovascular diseases. The investigators think that it may also play a role in preventing its progress.
Read the detailed description
The present study aimed to compare the effect of the consumption of the cake supplemented with cereal-like produces, such as chia or flaxseed, which have high soluble fiber content, on postprondial blood glucose and insulin values. It also aimed to evaluate its effect of individuals' saturation response after consumption, and to develop cake recipes involving chia and flax seed. The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced. In the main study, the effect of standard and test cakes containing 50 g digestible carbohydrates on postprandial blood glucose, insulin, and subjective saturation response will be investigated. The study will be conducted with 14 volunteers aged between 19 and years 64, with no acute or chronic disease, having a Body Mass Index (BMI) of 18.5-24.9 kg/m2, and with a Beck Depression Scale of 8 or less. Those using prescription drugs and/or fiber supplements, pregnant or lactating women, those consuming excessive alcohol (> 2 drinks/day), women in menstrual period, those having allergic reaction to chia or flaxseed will not be included in the study. Before the individuals are included in the study, anthropometric measurements will be taken, Beck Depression Scale will be administered in order to evaluate the depression status, and individuals will be informed about the purpose and content of the study, and signed Informed Consent Form will be obtained from all participants. The individuals participating in the study will come to the research center once a week for four weeks to consume the cakes. Individuals will stay hungry for 10-12 hours after eating their usual dinner the night before the test and they will only consume water during this period. Baseline/fasting appetite responses of the individuals who came to the research center after this fasting period will be measured with a 100-mm visual analog scale (VAS) and baseline/fasting blood samples will be taken. The cakes will be consumed within 10 minutes and appetite responses will be measured using the 100-mm Visual Analog Scala (VAS) at 15, 30, 60, 90, 120, 180 minutes, and then venous blood samples will be taken by the nurse-in-charge. During this three-hour period, the participants will not be allowed to leave the research center, nor will they be allowed to consume any other food. Blood samples will be analyzed at the Forum Yaşam Hospital Biochemistry Laboratory. Glucose values will be analyzed by UV test analysis and insulin values will be analyzed by the chemical immunoassay method. The data obtained will be compared with the appropriate statistical methods and interpreted in the light of the literature.
- Conditions
- Grain-Like Products, Postprandial Glucose, Plasma Insulin, Subjective Saturation Response, Healthy Individuals
- Being tested
- Flaxseed and Chia
- Keywords
- Carbohydrate, Chia, Flaxseed, Blood glucose, Insulin, Appetite
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed and ChiaDietary supplement
Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes
| Study group | Role | What they receive |
|---|---|---|
| Nutritional analyzes applied to four cakes | No intervention | The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced. |
| Flaxseed cake | Experimental | Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake Receives: Dietary Supplement: Flaxseed and Chia |
| Chia cake | Experimental | Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake Receives: Dietary Supplement: Flaxseed and Chia |
| Flaxseed and chia cake | Experimental | Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake Receives: Dietary Supplement: Flaxseed and Chia |
| Standart | Experimental | Measuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake Receives: Dietary Supplement: Flaxseed and Chia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flax Seed Cake and Blood Glucose Parameters
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
Measured: One day
Flax Seed Cake and Plasma Insulin Levels
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
Measured: One day
Flax Seed Cake and Satiety Response Measurements
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
Measured: One day
Chia Cake and Blood Glucose Parameters
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
Measured: One day
Chia Cake and Plasma Insulin Levels
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
Measured: One day
Chia Cake and Satiety Response Measurements
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
Measured: One day
Flax Seed and Chia Cake and Blood Glucose Parameters
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
Measured: One day
Flax Seed and Chia Cake and Plasma Insulin Levels
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
Measured: One day
Flax Seed Cake and Satiety Response Measurements
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
Measured: One day
Standart Cake and Blood Glucose Parameters
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
Measured: One day
Standart Cake and Plasma Insulin Levels
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
Measured: One day
Standart Cake and Satiety Response Measurements
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 May 2022
- Primary completion19 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grain-Like ProductsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Cross over
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem ÖZPAK AKKUŞ, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358561
- Sponsor's protocol ID
- ChiaFlaxseed
- Status last verified
- Jun 2022
- First submitted
- 22 Apr 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with permission of principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of Grain-Like Products on Postprandial Glucose, Insulin and Subjective Saturation Response in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05358561
- Acronym / sponsor ID
- ChiaFlaxseed
- Conditions
- Grain-Like Products, Postprandial Glucose, Plasma Insulin, Subjective Saturation Response, Healthy Individuals
- Keywords
- Carbohydrate, Chia, Flaxseed, Blood glucose, Insulin, Appetite
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 19 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 3 May 2022 (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.
This study is a pioneering study in which the effect of the consumption of cakes produced with the addition of cereal-like products such as chia and flax seeds, which have high soluble fiber content, on blood glucose and insulin values, and the effect on the satiety response of individuals after consumption of cakes, will be a pioneer in many subjects.
As a result of the study, the relationships between the changes in the investigated parameters and the possible changes in these parameters will be revealed. The results obtained suggest that foods rich in soluble fiber such as chia and flaxseed and foods produced with the possible synergetic effect of chia and flaxseed are used in healthy and safe products suitable for our consumption habits, and that these products are both protective and protective against the development of complications such as obesity and type 2 diabetes, cardiovascular diseases. The investigators think that it may also play a role in preventing its progress.
Detailed description
The present study aimed to compare the effect of the consumption of the cake supplemented with cereal-like produces, such as chia or flaxseed, which have high soluble fiber content, on postprondial blood glucose and insulin values. It also aimed to evaluate its effect of individuals' saturation response after consumption, and to develop cake recipes involving chia and flax seed. The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced. In the main study, the effect of standard and test cakes containing 50 g digestible carbohydrates on postprandial blood glucose, insulin, and subjective saturation response will be investigated. The study will be conducted with 14 volunteers aged between 19 and years 64, with no acute or chronic disease, having a Body Mass Index (BMI) of 18.5-24.9 kg/m2, and with a Beck Depression Scale of 8 or less. Those using prescription drugs and/or fiber supplements, pregnant or lactating women, those consuming excessive alcohol (> 2 drinks/day), women in menstrual period, those having allergic reaction to chia or flaxseed will not be included in the study. Before the individuals are included in the study, anthropometric measurements will be taken, Beck Depression Scale will be administered in order to evaluate the depression status, and individuals will be informed about the purpose and content of the study, and signed Informed Consent Form will be obtained from all participants. The individuals participating in the study will come to the research center once a week for four weeks to consume the cakes. Individuals will stay hungry for 10-12 hours after eating their usual dinner the night before the test and they will only consume water during this period. Baseline/fasting appetite responses of the individuals who came to the research center after this fasting period will be measured with a 100-mm visual analog scale (VAS) and baseline/fasting blood samples will be taken. The cakes will be consumed within 10 minutes and appetite responses will be measured using the 100-mm Visual Analog Scala (VAS) at 15, 30, 60, 90, 120, 180 minutes, and then venous blood samples will be taken by the nurse-in-charge. During this three-hour period, the participants will not be allowed to leave the research center, nor will they be allowed to consume any other food. Blood samples will be analyzed at the Forum Yaşam Hospital Biochemistry Laboratory. Glucose values will be analyzed by UV test analysis and insulin values will be analyzed by the chemical immunoassay method. The data obtained will be compared with the appropriate statistical methods and interpreted in the light of the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- Cross over
| Arm | Type | Receives |
|---|---|---|
| Nutritional analyzes applied to four cakes | No intervention | –The study is two-fold. In the preliminary study, the standard and test cakes (chia added cake, flax seed added cake, and chia+flax seed added cake) were developed and the amount of cake containing 50 g carbohydrate and the amount of moisture, ash, pulp, protein, fat, and digestible carbohydrate will be determined via analyses that will be carried at Toros University Food Chemistry Laboratory. Based on the results obtained, the amount of cakes containing 50 g digestible carbohydrate will be calculated and produced. |
| Flaxseed cake | Experimental | Dietary Supplement: Flaxseed and ChiaMeasuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed cake |
| Chia cake | Experimental | Dietary Supplement: Flaxseed and ChiaMeasuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of chia cake |
| Flaxseed and chia cake | Experimental | Dietary Supplement: Flaxseed and ChiaMeasuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed and chia cake |
| Standart | Experimental | Dietary Supplement: Flaxseed and ChiaMeasuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of standart cake |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The study will be conducted with 14 volunteers
- Aged between 19 and years 64
- No acute or chronic disease
- Body Mass Index (BMI) of 18.5-24.9 kg/m2
- Beck Depression Scale of 8 or less.
Key exclusion criteria (5 listed)
- Using prescription drugs and/or fiber supplements
- Pregnant or lactating women
- Consuming excessive alcohol (> 2 drinks/day)
- Women in menstrual period
- Having allergic reaction to chia or flaxseed
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 |
|---|---|---|
| Flaxseed and ChiaMeasuring blood glucose levels, plasma insulin and the satiety response levels of individuals after consumption of flaxseed, chia, flaxseed + chia and standart cakes | Dietary supplement | Chia cake, Flaxseed and chia cake, Flaxseed cake, Standart |
Primary outcome
Flax Seed Cake and Blood Glucose Parameters
Time frame: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
Flax Seed Cake and Plasma Insulin Levels
Time frame: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
Flax Seed Cake and Satiety Response Measurements
Time frame: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed cake.
Chia Cake and Blood Glucose Parameters
Time frame: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
Chia Cake and Plasma Insulin Levels
Time frame: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
Chia Cake and Satiety Response Measurements
Time frame: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of chia cake.
Flax Seed and Chia Cake and Blood Glucose Parameters
Time frame: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
Flax Seed and Chia Cake and Plasma Insulin Levels
Time frame: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
Flax Seed Cake and Satiety Response Measurements
Time frame: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of flax seed and chia cake.
Standart Cake and Blood Glucose Parameters
Time frame: One day
Measurement of blood glucose parameters seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
Standart Cake and Plasma Insulin Levels
Time frame: One day
Measurement of plasma insulin levels seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
Standart Cake and Satiety Response Measurements
Time frame: One day
Measurement of the satiety response seven times (0. minute, 15. minute, 30. minute, 60. minute, 90. minute, 120. minute, 180. minute) within three hours after consumption of standart cake.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No. Data can be shared with permission of principal investigator
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed and Chia in people with Grain-Like Products and Postprandial Glucose, run by Toros University at 1 site in Turkey (Türkiye).
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 5 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 23 Jun 2022. 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 Turkey (Türkiye). 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?
Contact Özlem ÖZPAK AKKUŞ, PhD (+905051397978, dytozlemozpak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flax Seed Cake and Blood Glucose Parameters (time frame: One day). The study lists 12 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 23 Jun 2022; AzTrials last refreshed its copy on 8 Nov 2026.