Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05528874
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2022-09-01
Brief Title:
NUTRACORE Glycaemic Index and Appetite
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
Glycemic Index Analysis of Functional Bakery Products on a Group of Healthy Volunteers a NUTRACORE Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NTRCR-vivo
Brief 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 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
1 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
2 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
3 Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia
4 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
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
1 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
2 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
3 Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia
4 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 mmolL or mgdl 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 regulationThe 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
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 mmolL or mgdl 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 regulationThe 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None