NUTRACORE, Glycaemic Index and Appetite

NCT05528874 | Completed

• 1 other identifier: CE 054/2022
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia
4. 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.

Conditions

Hyperglycemia; Hyperglycemia, Postprandial; Appetitive Behavior; Hyperinsulinism; Consumer Preference

Outcome Measures

Primary Outcomes (4)

• 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

• 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)

• 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)

• 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 Outcomes (5)

• 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)

• 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

Other Outcomes (2)

• Weight

  At fasting for each of the 7 days

• Body circumferences

  At fasting for each of the 7 days

Study Arms (2)

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.

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.

Dietary Supplement: Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes; Dietary Supplement: Crossover: Recipe 5 before recipe 4

Interventions

Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes DIETARY_SUPPLEMENT

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.

Also known as: Recipe 1,2,3

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 5 DIETARY_SUPPLEMENT

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.

Also known as: Recipe 4-5

Group 1: randomized to receive recipe 4 after the 5 days single arm study, and then recipe 5

Crossover: Recipe 5 before recipe 4 DIETARY_SUPPLEMENT

Same as previous group, but starting with recipe 5

Also known as: Recipe 5-4

Group 2: randomized to receive recipe 5 after the 5 days single arm study, and then recipe 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Maggiore della Carita: lead
• Polo AgriFood - Miac Scpa: collaborator
• Albertengo Panettoni: collaborator

Study Sites (1)

: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont

Novara, 28100, Italy

Location

Related Publications (10)

• 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.

  PMID: 25590950 BACKGROUND

• Ludwig 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.

  PMID: 11988062 BACKGROUND

• Englyst 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.

  PMID: 12628028 BACKGROUND

• Sivakamasundari 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.

  PMID: 33499662 BACKGROUND

• Soh 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.

  PMID: 10334648 BACKGROUND

• Loper 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.

  PMID: 26024495 BACKGROUND

• Chupeerach 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.

  PMID: 35223410 BACKGROUND

• Wang 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.

  PMID: 32092303 BACKGROUND

• Peters 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.

  PMID: 27522037 BACKGROUND

• Deloose 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.

  PMID: 28148502 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Appetitive Behavior; Hyperinsulinism; Consumer Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. in Clinical Nutrition and MD

Model Details: 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)

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: April 22, 2022
• Primary Completion: April 11, 2023
• Study Completion: September 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)