Glycemic and Insulinemic Response of Durum Wheat Bread

NCT06152874 | Completed

• 1 other identifier: W_D_UDI1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

In the last decades, the consumption of energy-dense diets, primarily consisting of highly digestible starchy foods like bread, along with a global increase in obesity rates and a sedentary lifestyle, has emerged as the main contributors to the development of non-communicable diseases such as cardiovascular diseases (CVD) and diabetes type 2. Therefore, there is a need to reduce the starch digestibility of bakery products, and in turn their glycemic index, with a specific emphasis on wheat bread. Several strategies have been used to decrease the glycemic index and insulin response of bread; however, most of these techniques have a detrimental effect on the texture, volume, taste, and color of bread, limiting the consumer's acceptability. Preservation of the native microstructure (cell wall integrity) and employing processing techniques to create a macrostructure (protein network and food matrix) can be used to influence the product structure and therefore how the product is chewed (oral processing), and how these factors can affect carbohydrate digestion and glycemic response. The aim of this study was to examine the effect of different textural characteristics of bread on oral processing in relation to the glycemic and insulin response of the three breads. In the present study, a total of 16 healthy volunteers will be recruited, and if eligible (they need to meet the inclusion and exclusion criteria), they will attend an oral processing test on three breads, a test to measure the glycemic index (ISO) and insulin response. The bread sample composition will be as follows: Bread A is made with 95% durum wheat fine semolina (\< 400 micrometer) + 5% gluten+ 1.2% yeast + 1% salt + 59% water Bread B is made with 80% durum wheat fine semolina (\< 400 micrometer) + 20% gluten+ 1.2% yeast + 1% salt + 59 % water Bread C is made with 80% durum wheat coarse semolina (\> 500 micrometer) + 20% gluten+ 1.2% yeast + 1% salt + 59 % water.

Conditions

Glucose Response; Glycemic Index; Insulin Response; Oral Processing

Keywords

glucose; insulin; durum wheat bread; oral processing; salivary amylase activity

Outcome Measures

Primary Outcomes (1)

• Post-prandial glycemic response

  Post-prandial glycemic response (incremental area under the curve)

  Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes)

Secondary Outcomes (12)

• Maximum peak for glucose

  Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes)

• Maximum peak for insulin

  Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes)

• Satiety using a 10 cm Visual Analogue Scale

  Time 2 hours (before the meal and after the meal at 30, 60 and 120 minutes)

• Gastrointestinal symptoms using a questionnaire with symptoms rated using a 10 cm Visual Analogue Scale

  Time 2 hours (before the meal and after the meal at 30, 60 and 120 minutes)

• Post-prandial insulinemic response

  Time 2 hours (sampling at 0 -fasting-, 15, 30, 45, 60, 90 and 120 minutes)

Study Arms (5)

glucose solution 1

ACTIVE COMPARATOR

glucose solution prepared dissolving 55 g of monohydrate glucose powder in 250 mL of water

Other: consumption of glucose solution 1

glucose solution 2

ACTIVE COMPARATOR

glucose solution prepared dissolving 55 g of monohydrate glucose powder in 250 mL of water

Other: consumption of glucose solution 2

BREAD A

EXPERIMENTAL

bread made with 95% durum wheat fine semolina (\< 400 micrometer)+ 5% of gluten+ 1.2% of yeast + 1% of salt + 59% of water (portion corresponding to 50 g available carbohydrates) +250 mL water

Other: consumption of Bread A and oral processing

BREAD B

EXPERIMENTAL

bread made with 80% durum wheat fine semolina (\< 400 micrometer)+ 20% of gluten+ 1.2% of yeast + 1% of salt + 59% of water (portion corresponding to 50 g available carbohydrates) +250 mL water

Other: consumption of Bread B and oral processing

BREAD C

EXPERIMENTAL

bread made with 80% durum wheat coarse semolina (\> 500 micrometer)+ 20% of gluten+ 1.2% of yeast + 1% of salt + 59% of water) (portion corresponding to 50 g available carbohydrates) +250 mL water

Other: consumption of Bread C and oral processing

Interventions

consumption of glucose solution 1 OTHER

glucose solution prepared dissolving 55 g of monohydrate glucose powder in 250 mL of water

Also known as: glucose solution

glucose solution 1

consumption of glucose solution 2 OTHER

glucose solution prepared dissolving 55 g of monohydrate glucose powder in 250 mL of water

Also known as: glucose solution

glucose solution 2

consumption of Bread A and oral processing OTHER

bread made with 95% durum wheat fine semolina (\< 400 micrometer) + 5% of gluten + 1.2% of yeast + 1% of salt + 59%of water) (portion corresponding to 50 g available carbohydrates) + 250 mL water

BREAD A

consumption of Bread B and oral processing OTHER

bread made with 80% durum wheat fine semolina (\< 400micrometer) + 20% of gluten+ 1.2% of yeast + 1% of salt + 59%of water (portion corresponding to 50g available carbohydrates) +250 mL water

BREAD B

consumption of Bread C and oral processing OTHER

bread made with 80% durum wheat coarse semolina (\> 500micrometer)+ 20% of gluten+ 1.2% of yeast + 1% of salt + 59%of water (portion corresponding to 50g available carbohydrates) +250 mL water

BREAD C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-50 years old;
• Have good general health;
• Have normal smell and taste functions;
• Have a normal body mass index (BMI 18.5-24.9 kg/m2) (based on self-reported weight and height).

You may not qualify if:

• Have dental braces or a piercing in or around the mouth (except removable piercings);
• Use medications known to affect glucose tolerance and influence digestion and absorption of nutrients (excluding oral contraceptives) - stable doses of oral contraceptives, acetylsalicylic acid, thyroxin, vitamins, and mineral supplements or drugs to treat hypertension are acceptable.
• Have a known history of diabetes mellitus or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions;
• Have a major medical or surgical event requiring hospitalization within the preceding 3 months;
• Have any food allergy or intolerance for gluten;
• Being pregnant or lactating (self-reported);
• Use medication that may affect the function of taste, smell, mastication, and salivation;

Sponsors & Collaborators

• University of Udine: lead
• Wageningen University and Research: collaborator

Study Sites (1)

Department of Agricultural, Food, Environmental and Animal Sciences, University of Udine,

Udine, 33100, Italy

Location

Related Publications (16)

• Tagliasco M, Tecuanhuey M, Reynard R, Zuliani R, Pellegrini N, Capuano E. Monitoring the effect of cell wall integrity in modulating the starch digestibility of durum wheat during different steps of bread making. Food Chem. 2022 Dec 1;396:133678. doi: 10.1016/j.foodchem.2022.133678. Epub 2022 Jul 15.

  PMID: 35849983 BACKGROUND

• Vanhatalo S, Dall'Asta M, Cossu M, Chiavaroli L, Francinelli V, Pede GD, Dodi R, Narvainen J, Antonini M, Goldoni M, Holopainen-Mantila U, Cas AD, Bonadonna R, Brighenti F, Poutanen K, Scazzina F. Pasta Structure Affects Mastication, Bolus Properties, and Postprandial Glucose and Insulin Metabolism in Healthy Adults. J Nutr. 2022 Apr;152(4):994-1005. doi: 10.1093/jn/nxab361. Epub 2023 Feb 18.

  PMID: 36967189 BACKGROUND

• Dall'Asta M, Dodi R, Pede GD, Marchini M, Spaggiari M, Gallo A, Righetti L, Brighenti F, Galaverna G, Dall'Asta C, Ranieri R, Folloni S, Scazzina F. Postprandial blood glucose and insulin responses to breads formulated with different wheat evolutionary populations (Triticum aestivum L.): A randomized controlled trial on healthy subjects. Nutrition. 2022 Feb;94:111533. doi: 10.1016/j.nut.2021.111533. Epub 2021 Nov 3.

  PMID: 34936948 BACKGROUND

• Dhital S, Bhattarai RR, Gorham J, Gidley MJ. Intactness of cell wall structure controls the in vitro digestion of starch in legumes. Food Funct. 2016 Mar;7(3):1367-79. doi: 10.1039/c5fo01104c.

  PMID: 26786854 BACKGROUND

• Lau E, Soong YY, Zhou W, Henry J. Can bread processing conditions alter glycaemic response? Food Chem. 2015 Apr 15;173:250-6. doi: 10.1016/j.foodchem.2014.10.040. Epub 2014 Oct 19.

  PMID: 25466020 BACKGROUND

• Stamataki NS, Yanni AE, Karathanos VT. Bread making technology influences postprandial glucose response: a review of the clinical evidence. Br J Nutr. 2017 Apr;117(7):1001-1012. doi: 10.1017/S0007114517000770. Epub 2017 May 2.

  PMID: 28462730 BACKGROUND

• Zou W, Sissons M, Warren FJ, Gidley MJ, Gilbert RG. Compact structure and proteins of pasta retard in vitro digestive evolution of branched starch molecular structure. Carbohydr Polym. 2016 Nov 5;152:441-449. doi: 10.1016/j.carbpol.2016.06.016. Epub 2016 Jun 3.

  PMID: 27516291 BACKGROUND

• Korompokis K , De Brier N , Delcour JA . Differences in endosperm cell wall integrity in wheat (Triticum aestivum L.) milling fractions impact on the way starch responds to gelatinization and pasting treatments and its subsequent enzymatic in vitro digestibility. Food Funct. 2019 Aug 1;10(8):4674-4684. doi: 10.1039/c9fo00947g. Epub 2019 Jul 11.

  PMID: 31292590 BACKGROUND

• Chen X, He X, Zhang B, Sun L, Liang Z, Huang Q. Wheat gluten protein inhibits alpha-amylase activity more strongly than a soy protein isolate based on kinetic analysis. Int J Biol Macromol. 2019 May 15;129:433-441. doi: 10.1016/j.ijbiomac.2019.01.215. Epub 2019 Feb 1.

  PMID: 30716375 BACKGROUND

• Edwards CH, Grundy MM, Grassby T, Vasilopoulou D, Frost GS, Butterworth PJ, Berry SE, Sanderson J, Ellis PR. Manipulation of starch bioaccessibility in wheat endosperm to regulate starch digestion, postprandial glycemia, insulinemia, and gut hormone responses: a randomized controlled trial in healthy ileostomy participants. Am J Clin Nutr. 2015 Oct;102(4):791-800. doi: 10.3945/ajcn.114.106203. Epub 2015 Sep 2.

  PMID: 26333512 BACKGROUND

• Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet. 2017 Jun 3;389(10085):2239-2251. doi: 10.1016/S0140-6736(17)30058-2. Epub 2017 Feb 10.

  PMID: 28190580 BACKGROUND

• Chen Y, Capuano E, Stieger M. Chew on it: influence of oral processing behaviour on in vitro protein digestion of chicken and soya-based vegetarian chicken. Br J Nutr. 2021 Nov 14;126(9):1408-1419. doi: 10.1017/S0007114520005176. Epub 2020 Dec 28.

  PMID: 33645495 BACKGROUND

• Gao J, Lin S, Jin X, Wang Y, Ying J, Dong Z, Zhou W. In vitro digestion of bread: How is it influenced by the bolus characteristics? J Texture Stud. 2019 Jun;50(3):257-268. doi: 10.1111/jtxs.12391. Epub 2019 Feb 14.

  PMID: 30693521 BACKGROUND

• Li HT, Li Z, Fox GP, Gidley MJ, Dhital S. Protein-starch matrix plays a key role in enzymic digestion of high-amylose wheat noodle. Food Chem. 2021 Jan 30;336:127719. doi: 10.1016/j.foodchem.2020.127719. Epub 2020 Aug 1.

  PMID: 32768911 BACKGROUND

• Mosca AC, Moretton M, Angelino D, Pellegrini N. Effect of presence of gluten and spreads on the oral processing behavior of breads. Food Chem. 2022 Mar 30;373(Pt B):131615. doi: 10.1016/j.foodchem.2021.131615. Epub 2021 Nov 16.

  PMID: 34839974 BACKGROUND

• Tagliasco M, Capuano E, Dall'Asta M, Renzetti S, Fogliano V, Pellegrini N. The combined effect of gluten addition and semolina cell wall integrity reduces the oral sugar release and the insulinemic response to bread in healthy volunteers. Eur J Nutr. 2024 Nov 15;64(1):6. doi: 10.1007/s00394-024-03517-5.

  PMID: 39546030 DERIVED

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nicoletta Pellegrini, PhD

  Department of Food Environmental and Animal Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: December 1, 2023
• Study Start: September 19, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 23, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (1)