跳至主要内容
临床试验/NCT05528874
NCT05528874已完成不适用

Glycemic Index Analysis of Functional Bakery Products on a Group of Healthy Volunteers, a NUTRACORE Study

Azienda Ospedaliero Universitaria Maggiore della Carita2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Blood Glucose

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Subject and investigators cannot know which of the last 2 formulations are given and the unmasking will be made by the coordinator group of Nutracore project

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Blood Glucose

时间窗: 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

Ghrelin

时间窗: 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

COEQ (Control of Eating Questionnaire)

时间窗: 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

GLP-1

时间窗: 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

次要结局

  • Leptin(At fasting for each of the 7 days)
  • Glycated Hemoglobin (Hb1ac)(At fasting for each of the 7 days)
  • Customer preference and satisfaction(After the ingestion for each of the 5 days with biscuits)
  • Insulin(Change from fasting Insulin at time 15, 30, 45, 60, 90, 120, (180))
  • C-Peptide(Change from fasting C-Peptide at time 15, 30, 45, 60, 90, 120, (180))

研究者

发起方
Azienda Ospedaliero Universitaria Maggiore della Carita
申办方类型
Other
责任方
Principal Investigator
主要研究者

Flavia Prodam

Associated Prof. in Clinical Nutrition and MD

Azienda Ospedaliero Universitaria Maggiore della Carita

研究点 (2)

Loading locations...

相似试验

NUTRACORE, Glycaemic Index and Appetite | 临床试验