Hyperglycemia Clinical Trial
— NTRCR-vivoOfficial title:
Glycemic Index Analysis of Functional Bakery Products on a Group of Healthy Volunteers, a NUTRACORE Study
Verified date | September 2023 |
Source | Azienda Ospedaliero Universitaria Maggiore della Carita |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | September 1, 2023 |
Est. primary completion date | April 11, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont | Novara |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero Universitaria Maggiore della Carita | Albertengo Panettoni, Polo AgriFood - Miac Scpa |
Italy,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Weight | Assessment of weight in each day as a potential confounding factor during statistical analyses | At fasting for each of the 7 days | |
Other | Body circumferences | Assessment of body circumferences (waist and hip) in each day as potential confounding factors during statistical analyses | At fasting for each of the 7 days | |
Primary | Blood Glucose | Variation of glucose in time for each day after the ingestion of a certain food | Change from fasting glucose at time 15, 30, 45, 60, 90, 120, (180) minutes | |
Primary | 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 | Differences between VAS scores before food ingestion (h 9:00), before lunch (h: 13:00), and before dinner (h: 20:00) | |
Primary | Ghrelin | Variation of blood acylated and des-acylated ghrelin in time for each day after the ingestion of a certain food | Change from fasting ghrelin at time 15, 30, 45, 60, 90, 120, (180) | |
Primary | GLP-1 | Variation of blood GLP-1 in time for each day after the ingestion of a certain food | Change from fasting GLP-1 at time 15, 30, 45, 60, 90, 120, (180) | |
Secondary | Insulin | Variation of blood Insulin in time for each day after the ingestion of a certain food | Change from fasting Insulin at time 15, 30, 45, 60, 90, 120, (180) | |
Secondary | C-Peptide | Variation of blood C-Peptide in time for each day after the ingestion of a certain food | Change from fasting C-Peptide at time 15, 30, 45, 60, 90, 120, (180) | |
Secondary | Leptin | Assessment of fasting leptin in each day | At fasting for each of the 7 days | |
Secondary | Glycated Hemoglobin (Hb1ac) | Assessment of fasting Hb1ac in each day | At fasting for each of the 7 days | |
Secondary | 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 | After the ingestion for each of the 5 days with biscuits |
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