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Completed

NCT Number: NCT04790877

Effect of the Consumption of Alcohol-free Beers With Different Carbohydrates Composition on Postprandial Metabolic Response

The overall objective of this study is to explore the glycemic index and glycemic load induced by an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of isomaltulose and a resistant maltodextrin), as well as its postprandial metabolic response, compared to the effect induced by: a) an alcohol-free beer with a usual composition; b) an alcohol-free beer with modified composition (including almost full fermentation of carbohydrates and the addition of a resistant maltodextrin). This study includes two cross-over sub-studies recruiting healthy participants. In the first one, 10 healthy volunteers receive 25 g of carbohydrates coming from: regular alcohol-free beer (RB), alcohol-free beer with almost completely eliminated maltose and enriched with isomaltulose (2.5 g/100 mL) and a resistant maltodextrin (0.8 g/100 mL) (IMB), alcohol-free beer with the same maltose removal enriched with resistant maltodextrin (2.0 g/100 mL) (MB) and glucose solution. In the second study, 20 healthy volunteers are provided with 50 g of carbohydrates from white bread and water and the same meal plus 14.3 g of carbohydrates coming from: RB, IMB, MB and extra white bread. Blood is sampled at baseline and for 2 h, every 15 min, after ingestion.

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Key information

Conditions

Healthy Diet Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Postprandial Hyperglycemia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Investigación Sanitaria Aragón, Hospital Universitario Miguel Servet, Universidad de Zaragoza

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 18.5 and 27.5 kg/m2.

Exclusion criteria

  • Presence of cardiometabolic pathology such as dyslipemia (total cholesterol > 200 mg/dL and/or triglycerides > 150 mg/dL, and/or taking lipid-lowering drugs), prediabetes or type 1 or 2 diabetes mellitus (glucose ≥ 100 mg/dL and/or glycosylated hemoglobin ≥ 5.7% and/or taking hypoglycemic drugs) or high blood pressure without drug treatment.
  • Presence of other chronic pathologies that could interfere with the results of the study such as cardiovascular disease, kidney disease, thyroid disease or liver disease.
  • Presence of intestinal malabsorption syndromes and/or presence of Chron disease or ulcerative colitis.
  • Use of drugs that may interfere with lipid and/or glycidic metabolism.
  • Presence of some analytical alteration that could interfere with the results of the study.
  • Increased or decreased body weight of ≥ 5 kg in the last 6 months.
  • Gluten intolerance.
  • Regular intake of functional foods such as phytosterols or red rice yeast, which have a significant effect on lipid or glycidic metabolism, in the last 6 weeks.
  • Intake of vitamin supplements.
  • Hormone replacement therapy.

Treatment and study plan

Sub-study 1

Other

Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).

Sub-study 2

Other

Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.

Primary outcomes

  1. Glucose

    Time frame: Change from Baseline to 15-minutes after consumption of the beverage.

  2. Glucose

    Time frame: Change from Baseline to 30-minutes after consumption of the beverage.

  3. Glucose

    Time frame: Change from Baseline to 45-minutes after consumption of the beverage.

  4. Glucose

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  5. Glucose

    Time frame: Change from Baseline to 75-minutes after consumption of the beverage.

  6. Glucose

    Time frame: Change from Baseline to 90-minutes after consumption of the beverage.

  7. Glucose

    Time frame: Change from Baseline to 105-minutes after consumption of the beverage.

  8. Glucose

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  9. Insulin

    Time frame: Change from Baseline to 15-minutes after consumption of the beverage.

  10. Insulin

    Time frame: Change from Baseline to 30-minutes after consumption of the beverage.

  11. Insulin

    Time frame: Change from Baseline to 45-minutes after consumption of the beverage.

  12. Insulin

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  13. Insulin

    Time frame: Change from Baseline to 75-minutes after consumption of the beverage.

  14. Insulin

    Time frame: Change from Baseline to 90-minutes after consumption of the beverage.

  15. Insulin

    Time frame: Change from Baseline to 105-minutes after consumption of the beverage.

  16. Insulin

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  17. GLP-1

    Time frame: Change from Baseline to 15-minutes after consumption of the beverage.

  18. GLP-1

    Time frame: Change from Baseline to 30-minutes after consumption of the beverage.

  19. GLP-1

    Time frame: Change from Baseline to 45-minutes after consumption of the beverage.

  20. GLP-1

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  21. GLP-1

    Time frame: Change from Baseline to 75-minutes after consumption of the beverage.

  22. GLP-1

    Time frame: Change from Baseline to 90-minutes after consumption of the beverage.

  23. GLP-1

    Time frame: Change from Baseline to 105-minutes after consumption of the beverage.

  24. GLP-1

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  25. GIP

    Time frame: Change from Baseline to 15-minutes after consumption of the beverage.

  26. GIP

    Time frame: Change from Baseline to 30-minutes after consumption of the beverage.

  27. GIP

    Time frame: Change from Baseline to 45-minutes after consumption of the beverage.

  28. GIP

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  29. GIP

    Time frame: Change from Baseline to 75-minutes after consumption of the beverage.

  30. GIP

    Time frame: Change from Baseline to 90-minutes after consumption of the beverage.

  31. GIP

    Time frame: Change from Baseline to 105-minutes after consumption of the beverage.

  32. GIP

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

Secondary outcomes

  1. Leptin

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  2. Leptin

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  3. Glucagon

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  4. Glucagon

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  5. Ghrelin

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  6. Ghrelin

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  7. Polypeptide Y

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  8. Polypeptide Y

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  9. Pancreatic polypeptide

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  10. Pancreatic polypeptide

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  11. HDL cholesterol

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  12. HDL cholesterol

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  13. LDL cholesterol

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  14. LDL cholesterol

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

  15. Triglycerides

    Time frame: Change from Baseline to 60-minutes after consumption of the beverage.

  16. Triglycerides

    Time frame: Change from Baseline to 120-minutes after consumption of the beverage.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 10, 2021
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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