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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03831893
Other study ID # 2019-00980
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2019
Est. completion date August 13, 2019

Study information

Verified date October 2019
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall goal is to increase the knowledge that can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the purpose of this study is to evaluate effects on metabolic test markers of Nopal (Opuntia) in healthy humans.


Description:

The study include three visits at the research unit. At two of the visits the test subjects consume nopal in different doses. At one visit the subjects will consume a reference product. The intervention products are consumed at breakfast (at 8.00) and metabolic effects are investigated 3 hours postprandially. Consumption of the intervention products is separated by a one week washout period.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date August 13, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria:

Healthy men and women (non-smokers), BMI 18,5-30 kg/m2, and with no known metabolic disorders or food allergies will be recruited to the studies. The test subjects should consume a normal diet in accordance with the Nordic Nutrition Recommendations.

Exclusion Criteria:

Fasting blood glucose >6.1 mmol/L. Metabolic diseases or conditions. Food allergies or gastro- intestinal conditions. Consumption of probiotics, antibiotics or other drugs..

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nopal food product 1
Dried Nopal incorporated in a food product
Nopal food product 2
Dried Nopal incorporated in a food product
control
Food Product without nopal

Locations

Country Name City State
Sweden Food Technology, engineering and Nutrition, LTH, Lund University Lund

Sponsors (1)

Lead Sponsor Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood glucose tolerance Repeated blood glucose determinations in the postprandial period after breakfast. The area under the curve, using incremental changes from baseline, are used in the statistical evaluation to determine glucose tolerance. 3 hours after breakfast (measurements at fasting, at 15 min, 30 min, 45 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Secondary subjective appetite sensations changes in subjective appetite sensations will be registered in the postprandial period at breakfast, using 0 - 100 mm visual analogue scales (VAS scale). The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a appetite sensation. The hunger sensations to measure are: hunger, satiety and desire to eat.The area under the curve are used in the statistical evaluation to determine 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Area under the curve is calculated and used in the statistical evaluations)
Secondary Mood Changes in mood parameters (valence and activity) will be registered in the postprandial period after breakfast.The mood measurements will be assessed using the Swedish Core Affect Scale which included three self-reporting rating scales for evaluating valence (unpleasantness-pleasantness) and for activation (quietness-excitement), respectively. The subjective mood ratings are registered using 0 mm-100 mm VAS. The two end points of the scales (i.e. 0 mm and 100 mm) represent the minimum and maximum, respectively, agreement with a sensation to be rated.The valence rating is assessed by obtaining a mean rating of three scales graded from displeased-pleased, sad-glad and depressed-happy, respectively, and the rating of activation is assessed by obtaining a mean rating of three scales graded from sleepy-awake, passive-active and dull-peppy, respectively. 3 hours after breakfast (measurements at fasting, at 30 min, 60 min, 90 min, 120 min, 150 min and 180 min. Mean values are calculated and used in the statistical evaluations)
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