Status:
UNKNOWN
Effect of Two Alcohol-free Beers With Different Carbohydrates Composition on Lipids and Glucose Metabolism
Lead Sponsor:
Instituto Aragones de Ciencias de la Salud
Collaborating Sponsors:
Aragon Institute of Health Sciences
Conditions:
Glucose Metabolism Disorders (Including Diabetes Mellitus)
Overweight and Obesity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This a controlled, double-blind, randomized, cross designed study to determine the effect of an alcohol-free beer with low glycemic index carbohydrates (isomaltulose) and a resistant maltodextrin, com...
Detailed Description
The study involves a nutritional intervention with a controlled, double-blind, randomized, cross design. It includes 44 healthy subjects with a total duration of 20 weeks with a "wash-out/stabilizatio...
Eligibility Criteria
Inclusion
- Aged between 18 and 80 years.
- To provide informed consent in writing of voluntary participation in the study after having read the participant information sheet, and having consulted the doubts that may arise from it.
- Diagnosis of prediabetes or diabetes mellitus type 2 defined as: a) fasting glucose ≥ 100 mg/dL in the last 3 months; b) glycated hemoglobin ≥ 5.7% and ≤ 6.5%.
Exclusion
- Gluten intolerance.
- Taking lipid-lowering drugs.
- Taking antidiabetic drugs, except for metformin in a stable dose in the last 3 months.
- To be under treatment with insulin.
- Presence of uncontrolled endocrinological disease by including hypothyroidism.
- Regular intake of functional foods with plant sterols in the past 6 weeks.
- Intake of vitamin supplements.
- Hormone replacement therapy.
- High intake of alcohol (\> 30 g ethanol) on a regular basis.
- Pregnancy or intention of pregnancy during the study since the proposed nutritional intervention may not be suitable for this situation.
- Serious illness of any type with less than 1-year life expectancy or if, in the opinion of the investigators, it would limit a stable diet throughout the study.
- To be under treatment with corticosteroids, hormonal treatment or antibiotics the 3 months prior to randomization.
- To take prebiotics, probiotics, vitamin supplements and any other drug that could influence the intestinal microbiota, in the 3 months prior to randomization.
- Any other circumstances which, according to researcher's assessment, could interfere with the correct development of nutritional intervention (e.g.: frequent trips during the study, failure to attend visits by personal or business circumstances, etc.).
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03337828
Start Date
March 1 2017
End Date
December 1 2017
Last Update
November 9 2017
Active Locations (1)
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1
Fernando Civeira
Zaragoza, Spain, 50009