HyperglycemiaNTRCR-vivoNCT05528874
NUTRACORE, Glycaemic Index and Appetite
A study testing Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes, Crossover: Recipe 4 before recipe 5 and Crossover: Recipe 5 before recipe 4 in people with Hyperglycemia and Hyperglycemia, Postprandial, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
In recent decades, the world prevalence of obesity and type 2 diabetes (DMT2) has increased dramatically, resulting in a global epidemic. One of the aspects more connected to the etiology of these pathologies is undoubtedly the concept of the glycemic index (GI) and glycemic load (CG). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Hyperglycemia, Postprandial, Appetitive Behavior
- What is being tested?
- Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes, Crossover: Recipe 4 before recipe 5 and Crossover: Recipe 5 before recipe 4
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2022to 1 Sep 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Absence of allergies or intolerances to tested foods
- Absence of drugs that affect glucose metabolism. Stable doses of oral contraceptives, acetylsalicylic acid, thyroxine, mineral supplements, medications for hypertension or osteoporosis are accepted.
- Criteria for exclusion:
- diagnosis or history of diabetes or reduced glucose tolerance.
- surgery or severe and acute illness in the last 3 months
- use of steroids, protease inhibitors or antipsychotics
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont
Novara, 28100
About this study
Official title: Glycemic Index Analysis of Functional Bakery Products on a Group of Healthy Volunteers, a NUTRACORE Study
In recent decades, the world prevalence of obesity and type 2 diabetes (DMT2) has increased dramatically, resulting in a global epidemic. One of the aspects more connected to the etiology of these pathologies is undoubtedly the concept of the glycemic index (GI) and glycemic load (CG). It has been shown that, with the same CG, that is of carbohydrates contained in a food, a food with a higher GI tends to raise blood sugar more quickly (and consequently insulin), causing several negative effects on the body. We now have sufficient evidence to show that high GI diets are associated with increased incidence of DMT2, hyperlipoproteinemia, and cardiovascular disease.
Although simple carbohydrates, namely sugars, have always been considered the major inducers of hyperglycemia and hyperinsulinemia, in reality also starches, or complex carbohydrates digestible by humans, may lead to an increase in blood sugar levels which is not as rapid but often equally harmful to health, since the GC is generally higher.
Read more
The reason why a high GI diet is responsible for this increased risk of developing pathologies is not unambiguous. We can identify at least 4 probable mechanisms.
- Sudden hyperglycemia tends to cause insulin to rise beyond what is necessary, leading subsequently to the risk of hypoglycemia and thus an excessive feeling of hunger. Increased energy intake and obesity.
- Excess insulin secretion, aggravated by insulin resistance, represents an effort for the pancreas with the risk, over time, to arrive at a deficit of insulin-dependent diabetes type 2 insulin production
- Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia
- Fat accumulation, especially in the abdominal region, is associated with chronic inflammation and insulin resistance by type 2 diabetes tissues and metabolic syndrome In addition to these reasons, a high GI diet, typically called Western Diet, is also generally deficient in plant foods, rich in antioxidants and photo compounds with anti-inflammatory action, without which the process of chronic organic inflammation is accelerated, even in the absence of real obesity.
Read the detailed description
For these reasons, in recent years the food industry has tried, not always successfully, to experiment with alternative formulations for its products, implementing a series of techniques to reduce the GI of foods, in particular those based on cereal flour. There are different methods useful to reduce the GI; in particular, the most impacting aspects of the GI of food containing carbohydrates are the sugar content, the starch content, the type of starch, the cooking method, previous processing, pre-cooking, post-cooking cooling, soaking, particle size and fiber quantity.
Increased consumption of soluble fiber is associated with reduced absorption of sugars in the intestine and therefore a reduced GI. On the contrary, most of the fibers contained in cereals and tubers are not soluble. For this reason, the direct effect of fibers on glycemic absorption is not significant. On the other hand, whole grains generally have a lower glycemic index than refined grains and this may be due to a combination of factors such as reduced digestibility, higher starch-content resistance, and the effects of other constituents of bran (such as lipids). Insoluble fibers are also attributed to a greater satiating effect.
The determination of the glycemic index can be estimated in vitro with good accuracy through an artificial digestive apparatus, or dynamic gastric model (DGM) but the gold standard remains the analysis of the glycemic response on subjects in vivo, typically volunteers. The ISO standard 26642 guidelines of 2010 represent the gold standard for the analysis of GI in humans and consists of a few simple steps that require blood sampling to determine blood sugar at the time 0, 15, 30, 45, 60, 90, and 120 min. The GI is but the average of the proportions between the sum of the 7 areas created by placing time on the abscissa (in minutes) and the ordinate blood sugar levels at each T (expressed in mmol/L or mg/dl) after consuming the test food compared to the sum of the areas created after consuming the reference food, usually glucose.
Secondly, the modulation of the intake of sugars and calories can also be managed through alternative methods. It has been seen that, for example, different stimuli related to the sense of taste can modulate the sense of hunger and consequently the calorie intake in the following hours. This is especially true with the bitter taste. Appetite modulation due to the administration of particular foods was primarily associated with particular polymorphisms of receptor genes associated particularly with a bitter taste (TAS2R) and sweet (T1R2-T1R3). At the same time, the discovery of extra-oral receptors to recognize bitterness (extra-oral TAS2R) led the researchers to test the effects of administering particular bitter foods without the potential confounding effect of oral ingestion.
Among recent studies, some researchers have shown that the effect of reducing energy intake has not been statistically significant in a group of overweight women, at least for some types of encapsulated bitterness while others have proven that an intragastric infusion of bitters significantly reduced hunger in a group of normal-weight women. Another study, in the short term, showed instead that an administration of bitters encapsulated with the base of 'Gentiana Lutea' during the morning meal can significantly reduce the energy intake of the day.
Different types of bitters can stimulate different receptors of the TAS2R family. A recent review showed that the bitters most tested and used to determine changes in hunger and energy intake were Quinine, Denatonium Benzoate, Naringin, Secoiridoid, Hops, and Gentian. Bitter compounds, in comparison to other flavors, have proved to be the most effective in influencing eating behavior. This highlights the potential preventive role of bitter flavors in the fight against epidemic obesity. However, further studies are needed to understand which bitters are most useful for this purpose, and which subcategories of the population are most effective. Artemisia Absinthium is an edible and non-toxic plant, commonly called wormwood, for which analgesic, anti-inflammatory, and antidiabetic effects are documented. The bitter extract of this plant, if properly encapsulated, could also affect appetite regulation.The purpose of the first phase of this study is to test the GI of 3 different formulations, in the form of dietary biscuits, on 12 healthy volunteer subjects in order to calculate an average GI necessary for the company that provides the product to enrich the label with a final IG and start marketing. In the second phase, the same subjects will participate in a crossover study to test the same parameters of the first phase, with the addition of an investigation on the effects on hunger with 2 formulations of biscuits different from the first 3, one containing bitter encapsulated Artemisia Absinthium base. The chemotype of Artemisia absinthium used for the extract used is thujoni-free and therefore has no documented contraindication.
- Conditions
- Hyperglycemia, Hyperglycemia, Postprandial, Appetitive Behavior, Hyperinsulinism, Consumer Preference
- Being tested
- Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes, Crossover: Recipe 4 before recipe 5, Crossover: Recipe 5 before recipe 4
- Medical subject headings
- Hyperglycemia, Appetitive Behavior, Hyperinsulinism, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same intervention for both groups: glycaemic index assessment of 3 biscuits recipesDietary supplement
Also called Recipe 1,2,3
Following International standards ISO 26642 guidelines, subjects (at fasting) will have their glycemia measured and after will consume a solution containing 50g of glucose and 100g of water. In the following 2 hours, glycemia and other blood parameters will be taken 6 times (at 15, 30, 45, 60, 90, and 120 minutes). This protocol is repeated twice within 3 months. After these 2 days, with the same methods, they will come to our clinic to test 3 different recipes of biscuits (characteristics are presented on request). Subjects and investigators are not blinded to these biscuits characteristics.
Crossover: Recipe 4 before recipe 5Dietary supplement
Also called Recipe 4-5
After the assessment of fasting parameters, subjects will consume recipe 4 (chocolate biscuits) and perform a 180 min curve with blood taken at 15, 30, 45, 60, 90, 120, and 180 minutes. In this case, both investigators and patients are blinded to the presence of an additional "non-nutritive, non-toxic and without taste" encapsulated bitter compound (artemisia absinthium), that could be present in recipe 4 or recipe 5. On the second day (with at least a week gap), patients will consume recipe 5. Questionnaires and a food diary will also be requested for subjects for lunch and dinner.
Crossover: Recipe 5 before recipe 4Dietary supplement
Also called Recipe 5-4
Same as previous group, but starting with recipe 5
| Study group | Role | What they receive |
|---|---|---|
| Group 1: randomized to receive recipe 4 after the 5 days single arm study, and then recipe 5 | Experimental | Healthy volunteers that signed informed consent. Will consume all recipes in crescent order. Receives: Dietary Supplement: Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes; Dietary Supplement: Crossover: Recipe 4 before recipe 5 |
| Group 2: randomized to receive recipe 5 after the 5 days single arm study, and then recipe 4 | Experimental | Same as before but randomized to receive recipe 5 before recipe 4. Receives: Dietary Supplement: Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes; Dietary Supplement: Crossover: Recipe 5 before recipe 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Variation of glucose in time for each day after the ingestion of a certain food
Measured: Change from fasting glucose at time 15, 30, 45, 60, 90, 120, (180) minutes
COEQ (Control of Eating Questionnaire)
Variation of 20-item COEQ questionnaire 100mm VAS scales for each day after the ingestion of a certain food. Hunger, satiety, quality of life, and food craving were assessed through a 100 mm VAS-scale
Measured: Differences between VAS scores before food ingestion (h 9:00), before lunch (h: 13:00), and before dinner (h: 20:00)
Ghrelin
Variation of blood acylated and des-acylated ghrelin in time for each day after the ingestion of a certain food
Measured: Change from fasting ghrelin at time 15, 30, 45, 60, 90, 120, (180)
GLP-1
Variation of blood GLP-1 in time for each day after the ingestion of a certain food
Measured: Change from fasting GLP-1 at time 15, 30, 45, 60, 90, 120, (180)
Secondary outcomes (5)
Insulin
Variation of blood Insulin in time for each day after the ingestion of a certain food
Measured: Change from fasting Insulin at time 15, 30, 45, 60, 90, 120, (180)
C-Peptide
Variation of blood C-Peptide in time for each day after the ingestion of a certain food
Measured: Change from fasting C-Peptide at time 15, 30, 45, 60, 90, 120, (180)
Leptin
Assessment of fasting leptin in each day
Measured: At fasting for each of the 7 days
Glycated Hemoglobin (Hb1ac)
Assessment of fasting Hb1ac in each day
Measured: At fasting for each of the 7 days
Customer preference and satisfaction
Assessment of subject personal taste and preferences after the ingestion of the biscuits recipes. Questions are regarding taste, smell, consistency and knowledge about functional foods
Measured: After the ingestion for each of the 5 days with biscuits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start22 Apr 2022
- Primary completion11 Apr 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- This study is composed by 2 parts. The same participants are enrolled in a single arm study (5 days), followed by a cross-over part (2 days)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Polo AgriFood - Miac Scpa, Albertengo Panettoni
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528874
- Sponsor's protocol ID
- CE 054/2022
- Acronym
- NTRCR-vivo
- Status last verified
- Sep 2023
- First submitted
- 1 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be available
Publications
Kaur B, Ranawana V, Henry J. The Glycemic Index of Rice and Rice Products: A Review, and Table of GI Values. Crit Rev Food Sci Nutr. 2016;56(2):215-36. doi: 10.1080/10408398.2012.717976.
PubMed 25590950Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. doi: 10.1001/jama.287.18.2414.
PubMed 11988062Englyst KN, Vinoy S, Englyst HN, Lang V. Glycaemic index of cereal products explained by their content of rapidly and slowly available glucose. Br J Nutr. 2003 Mar;89(3):329-40. doi: 10.1079/BJN2002786.
PubMed 12628028Sivakamasundari SK, Priyanga S, Moses JA, Anandharamakrishnan C. Impact of processing techniques on the glycemic index of rice. Crit Rev Food Sci Nutr. 2022;62(12):3323-3344. doi: 10.1080/10408398.2020.1865259. Epub 2021 Jan 27.
PubMed 33499662Soh NL, Brand-Miller J. The glycaemic index of potatoes: the effect of variety, cooking method and maturity. Eur J Clin Nutr. 1999 Apr;53(4):249-54. doi: 10.1038/sj.ejcn.1600713.
PubMed 10334648Loper HB, La Sala M, Dotson C, Steinle N. Taste perception, associated hormonal modulation, and nutrient intake. Nutr Rev. 2015 Feb;73(2):83-91. doi: 10.1093/nutrit/nuu009.
PubMed 26024495Chupeerach C, Tapanee P, On-Nom N, Temviriyanukul P, Chantong B, Reeder N, Adegoye GA, Tolar-Peterson T. The influence of TAS2R38 bitter taste gene polymorphisms on obesity risk in three racially diverse groups. Biomedicine (Taipei). 2021 Sep 1;11(3):43-49. doi: 10.37796/2211-8039.1175. eCollection 2021.
PubMed 35223410Wang Q, Liszt KI, Depoortere I. Extra-oral bitter taste receptors: New targets against obesity? Peptides. 2020 May;127:170284. doi: 10.1016/j.peptides.2020.170284. Epub 2020 Feb 21.
PubMed 32092303Peters HPF, Koppenol W, Schuring EAH, Gouka R, Mela DJ, Blom WAM. The effect of two weeks ingestion of a bitter tastant mixture on energy intake in overweight females. Appetite. 2016 Dec 1;107:268-273. doi: 10.1016/j.appet.2016.08.013. Epub 2016 Aug 10.
PubMed 27522037Deloose E, Janssen P, Corsetti M, Biesiekierski J, Masuy I, Rotondo A, Van Oudenhove L, Depoortere I, Tack J. Intragastric infusion of denatonium benzoate attenuates interdigestive gastric motility and hunger scores in healthy female volunteers. Am J Clin Nutr. 2017 Mar;105(3):580-588. doi: 10.3945/ajcn.116.138297. Epub 2017 Feb 1.
PubMed 28148502
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Index Analysis of Functional Bakery Products on a Group of Healthy Volunteers, a NUTRACORE Study
- ClinicalTrials.gov ID
- NCT05528874
- Acronym / sponsor ID
- NTRCR-vivo / CE 054/2022
- Conditions
- Hyperglycemia, Hyperglycemia, Postprandial, Appetitive Behavior, Hyperinsulinism, Consumer Preference
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Polo AgriFood - Miac Scpa, Albertengo Panettoni
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 6 Sep 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.
In recent decades, the world prevalence of obesity and type 2 diabetes (DMT2) has increased dramatically, resulting in a global epidemic. One of the aspects more connected to the etiology of these pathologies is undoubtedly the concept of the glycemic index (GI) and glycemic load (CG). It has been shown that, with the same CG, that is of carbohydrates contained in a food, a food with a higher GI tends to raise blood sugar more quickly (and consequently insulin), causing several negative effects on the body. We now have sufficient evidence to show that high GI diets are associated with increased incidence of DMT2, hyperlipoproteinemia, and cardiovascular disease.
Although simple carbohydrates, namely sugars, have always been considered the major inducers of hyperglycemia and hyperinsulinemia, in reality also starches, or complex carbohydrates digestible by humans, may lead to an increase in blood sugar levels which is not as rapid but often equally harmful to health, since the GC is generally higher.
The reason why a high GI diet is responsible for this increased risk of developing pathologies is not unambiguous. We can identify at least 4 probable mechanisms.
- Sudden hyperglycemia tends to cause insulin to rise beyond what is necessary, leading subsequently to the risk of hypoglycemia and thus an excessive feeling of hunger. Increased energy intake and obesity.
- Excess insulin secretion, aggravated by insulin resistance, represents an effort for the pancreas with the risk, over time, to arrive at a deficit of insulin-dependent diabetes type 2 insulin production
- Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia
- Fat accumulation, especially in the abdominal region, is associated with chronic inflammation and insulin resistance by type 2 diabetes tissues and metabolic syndrome In addition to these reasons, a high GI diet, typically called Western Diet, is also generally deficient in plant foods, rich in antioxidants and photo compounds with anti-inflammatory action, without which the process of chronic organic inflammation is accelerated, even in the absence of real obesity.
Detailed description
For these reasons, in recent years the food industry has tried, not always successfully, to experiment with alternative formulations for its products, implementing a series of techniques to reduce the GI of foods, in particular those based on cereal flour. There are different methods useful to reduce the GI; in particular, the most impacting aspects of the GI of food containing carbohydrates are the sugar content, the starch content, the type of starch, the cooking method, previous processing, pre-cooking, post-cooking cooling, soaking, particle size and fiber quantity.
Increased consumption of soluble fiber is associated with reduced absorption of sugars in the intestine and therefore a reduced GI. On the contrary, most of the fibers contained in cereals and tubers are not soluble. For this reason, the direct effect of fibers on glycemic absorption is not significant. On the other hand, whole grains generally have a lower glycemic index than refined grains and this may be due to a combination of factors such as reduced digestibility, higher starch-content resistance, and the effects of other constituents of bran (such as lipids). Insoluble fibers are also attributed to a greater satiating effect.
The determination of the glycemic index can be estimated in vitro with good accuracy through an artificial digestive apparatus, or dynamic gastric model (DGM) but the gold standard remains the analysis of the glycemic response on subjects in vivo, typically volunteers. The ISO standard 26642 guidelines of 2010 represent the gold standard for the analysis of GI in humans and consists of a few simple steps that require blood sampling to determine blood sugar at the time 0, 15, 30, 45, 60, 90, and 120 min. The GI is but the average of the proportions between the sum of the 7 areas created by placing time on the abscissa (in minutes) and the ordinate blood sugar levels at each T (expressed in mmol/L or mg/dl) after consuming the test food compared to the sum of the areas created after consuming the reference food, usually glucose.
Secondly, the modulation of the intake of sugars and calories can also be managed through alternative methods. It has been seen that, for example, different stimuli related to the sense of taste can modulate the sense of hunger and consequently the calorie intake in the following hours. This is especially true with the bitter taste. Appetite modulation due to the administration of particular foods was primarily associated with particular polymorphisms of receptor genes associated particularly with a bitter taste (TAS2R) and sweet (T1R2-T1R3). At the same time, the discovery of extra-oral receptors to recognize bitterness (extra-oral TAS2R) led the researchers to test the effects of administering particular bitter foods without the potential confounding effect of oral ingestion.
Among recent studies, some researchers have shown that the effect of reducing energy intake has not been statistically significant in a group of overweight women, at least for some types of encapsulated bitterness while others have proven that an intragastric infusion of bitters significantly reduced hunger in a group of normal-weight women. Another study, in the short term, showed instead that an administration of bitters encapsulated with the base of 'Gentiana Lutea' during the morning meal can significantly reduce the energy intake of the day.
Different types of bitters can stimulate different receptors of the TAS2R family. A recent review showed that the bitters most tested and used to determine changes in hunger and energy intake were Quinine, Denatonium Benzoate, Naringin, Secoiridoid, Hops, and Gentian. Bitter compounds, in comparison to other flavors, have proved to be the most effective in influencing eating behavior. This highlights the potential preventive role of bitter flavors in the fight against epidemic obesity. However, further studies are needed to understand which bitters are most useful for this purpose, and which subcategories of the population are most effective. Artemisia Absinthium is an edible and non-toxic plant, commonly called wormwood, for which analgesic, anti-inflammatory, and antidiabetic effects are documented. The bitter extract of this plant, if properly encapsulated, could also affect appetite regulation.The purpose of the first phase of this study is to test the GI of 3 different formulations, in the form of dietary biscuits, on 12 healthy volunteer subjects in order to calculate an average GI necessary for the company that provides the product to enrich the label with a final IG and start marketing. In the second phase, the same subjects will participate in a crossover study to test the same parameters of the first phase, with the addition of an investigation on the effects on hunger with 2 formulations of biscuits different from the first 3, one containing bitter encapsulated Artemisia Absinthium base. The chemotype of Artemisia absinthium used for the extract used is thujoni-free and therefore has no documented contraindication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is composed by 2 parts. The same participants are enrolled in a single arm study (5 days), followed by a cross-over part (2 days)
| Arm | Type | Receives |
|---|---|---|
| Group 1: randomized to receive recipe 4 after the 5 days single arm study, and then recipe 5 | Experimental | Dietary Supplement: Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes, Dietary Supplement: Crossover: Recipe 4 before recipe 5Healthy volunteers that signed informed consent. Will consume all recipes in crescent order. |
| Group 2: randomized to receive recipe 5 after the 5 days single arm study, and then recipe 4 | Experimental | Dietary Supplement: Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes, Dietary Supplement: Crossover: Recipe 5 before recipe 4Same as before but randomized to receive recipe 5 before recipe 4. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Absence of allergies or intolerances to tested foods
- Absence of drugs that affect glucose metabolism. Stable doses of oral contraceptives, acetylsalicylic acid, thyroxine, mineral supplements, medications for hypertension or osteoporosis are accepted.
- diagnosis or history of diabetes or reduced glucose tolerance.
- surgery or severe and acute illness in the last 3 months
- use of steroids, protease inhibitors or antipsychotics
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Same intervention for both groups: glycaemic index assessment of 3 biscuits recipesAlso: Recipe 1,2,3Following International standards ISO 26642 guidelines, subjects (at fasting) will have their glycemia measured and after will consume a solution containing 50g of glucose and 100g of water. In the following 2 hours, glycemia and other blood parameters will be taken 6 times (at 15, 30, 45, 60, 90, and 120 minutes). This protocol is repeated twice within 3 months. After these 2 days, with the same methods, they will come to our clinic to test 3 different recipes of biscuits (characteristics are presented on request). Subjects and investigators are not blinded to these biscuits characteristics. | Dietary supplement | Group 1: randomized to receive recipe 4 after the 5 days single arm study, and then recipe 5, Group 2: randomized to receive recipe 5 after the 5 days single arm study, and then recipe 4 |
| Crossover: Recipe 4 before recipe 5Also: Recipe 4-5After the assessment of fasting parameters, subjects will consume recipe 4 (chocolate biscuits) and perform a 180 min curve with blood taken at 15, 30, 45, 60, 90, 120, and 180 minutes. In this case, both investigators and patients are blinded to the presence of an additional "non-nutritive, non-toxic and without taste" encapsulated bitter compound (artemisia absinthium), that could be present in recipe 4 or recipe 5. On the second day (with at least a week gap), patients will consume recipe 5. Questionnaires and a food diary will also be requested for subjects for lunch and dinner. | Dietary supplement | Group 1: randomized to receive recipe 4 after the 5 days single arm study, and then recipe 5 |
| Crossover: Recipe 5 before recipe 4Also: Recipe 5-4Same as previous group, but starting with recipe 5 | Dietary supplement | Group 2: randomized to receive recipe 5 after the 5 days single arm study, and then recipe 4 |
Primary outcome
Blood Glucose
Time frame: Change from fasting glucose at time 15, 30, 45, 60, 90, 120, (180) minutes
Variation of glucose in time for each day after the ingestion of a certain food
COEQ (Control of Eating Questionnaire)
Time frame: Differences between VAS scores before food ingestion (h 9:00), before lunch (h: 13:00), and before dinner (h: 20:00)
Variation of 20-item COEQ questionnaire 100mm VAS scales for each day after the ingestion of a certain food. Hunger, satiety, quality of life, and food craving were assessed through a 100 mm VAS-scale
Ghrelin
Time frame: Change from fasting ghrelin at time 15, 30, 45, 60, 90, 120, (180)
Variation of blood acylated and des-acylated ghrelin in time for each day after the ingestion of a certain food
GLP-1
Time frame: Change from fasting GLP-1 at time 15, 30, 45, 60, 90, 120, (180)
Variation of blood GLP-1 in time for each day after the ingestion of a certain food
5 secondary outcomes
Insulin
Time frame: Change from fasting Insulin at time 15, 30, 45, 60, 90, 120, (180)
C-Peptide
Time frame: Change from fasting C-Peptide at time 15, 30, 45, 60, 90, 120, (180)
Leptin
Time frame: At fasting for each of the 7 days
Glycated Hemoglobin (Hb1ac)
Time frame: At fasting for each of the 7 days
Customer preference and satisfaction
Time frame: After the ingestion for each of the 5 days with biscuits
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 28 Sep 2023.
- Background: PubMed 25590950Kaur B, Ranawana V, Henry J. The Glycemic Index of Rice and Rice Products: A Review, and Table of GI Values. Crit Rev Food Sci Nutr. 2016;56(2):215-36. doi: 10.1080/10408398.2012.717976.
- Background: PubMed 11988062Ludwig DS. The glycemic index: physiological mechanisms relating to obesity, diabetes, and cardiovascular disease. JAMA. 2002 May 8;287(18):2414-23. doi: 10.1001/jama.287.18.2414.
- Background: PubMed 12628028Englyst KN, Vinoy S, Englyst HN, Lang V. Glycaemic index of cereal products explained by their content of rapidly and slowly available glucose. Br J Nutr. 2003 Mar;89(3):329-40. doi: 10.1079/BJN2002786.
- Background: PubMed 33499662Sivakamasundari SK, Priyanga S, Moses JA, Anandharamakrishnan C. Impact of processing techniques on the glycemic index of rice. Crit Rev Food Sci Nutr. 2022;62(12):3323-3344. doi: 10.1080/10408398.2020.1865259. Epub 2021 Jan 27.
- Background: PubMed 10334648Soh NL, Brand-Miller J. The glycaemic index of potatoes: the effect of variety, cooking method and maturity. Eur J Clin Nutr. 1999 Apr;53(4):249-54. doi: 10.1038/sj.ejcn.1600713.
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- Individual participant dataSharing planned: No. No IPD will be available
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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 Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes, Crossover: Recipe 4 before recipe 5 and Crossover: Recipe 5 before recipe 4 in people with Hyperglycemia and Hyperglycemia, Postprandial, run by Azienda Ospedaliero Universitaria Maggiore della Carita 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 6 inclusion and 0 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 28 Sep 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 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: Change from fasting glucose at time 15, 30, 45, 60, 90, 120, (180) minutes). The study lists 4 primary outcomes in all. 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 NCT05528874, which also lists 10 linked publications.
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 28 Sep 2023.