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Completed

NCT Number: NCT03831893

Metabolic Effects of Nopal in Healthy Humans

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.

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Key information

Conditions

Healthy

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food Technology, engineering and Nutrition, LTH, Lund University

Lund, 22100, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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..

Treatment and study plan

Nopal food product 1

Other

Dried Nopal incorporated in a food product

Nopal food product 2

Other

Dried Nopal incorporated in a food product

Control

Other

Food Product without nopal

Primary outcomes

  1. Blood glucose tolerance

    Time frame: 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)

    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.

Secondary outcomes

  1. subjective appetite sensations

    Time frame: 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)

    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

  2. Mood

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Evaluation of Potentially Bioactive Foods With Respect to Effects on Metabolic Test Markers and Cognitive Variables

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
Oct 21, 2019

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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