Metabolic Effects of Nopal in Healthy Humans

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: control; Other: Nopal food product 1; Other: Nopal food product 2

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, 22100
    • Food Technology, engineering and Nutrition, LTH, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control; A food product similar to the test products but without nopal	Other: control; Food Product without nopal
Experimental: Nopal food product 1; Food product with Nopal	Other: Nopal food product 1; Dried Nopal incorporated in a food product
Experimental: Nopal food product 2; Food product with Nopal	Other: Nopal food product 2; Dried Nopal incorporated in a food product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Lund University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2019
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): August 13, 2019

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: February 5, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2019
• Last Update Submitted That Met QC Criteria: October 18, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2019-00980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No