Effects of Nopal Fractions on Postprandial Glucose Regulation and Appetite Variables in Healthy Humans

October 2, 2020 updated by: Anne Nilsson, Lund University

Evaluation of Potentially Bioactive Foods With Regard to Their Effects on Cardiometabolic Test Markers and Cognitive Variables

Postprandial effects of Nopal fractions on glucose and appetite regulation will be investigated in healthy humans, in a randomised controlled crossover trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • non-smokers
  • diet accordance with the Nordic Nutrition Recommendations
  • BMI: 18.5-25 kg/m2

Exclusion Criteria:

  • metabolic disorders
  • food allergies
  • no probiotics or other food /supplement which may interfere with the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: reference
Test product without the active components
Dietary supplement: Test product without the active components
Test product without the active components
Experimental: Nopal fraction 1
Fraction one out of two possible
Dietary supplement: Nopal fractions
Nopal flour were divided in two fractions and mixed in two different test breads
Experimental: Nopal fraction 2
Fraction two out of two possible
Dietary supplement: Nopal fractions
Nopal flour were divided in two fractions and mixed in two different test breads

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postprandial glucose tolerance
Time Frame: 0-180 min after start of the meal
effects on postprandial glucose tolerance after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
0-180 min after start of the meal
postprandial insulin concentrations
Time Frame: 0-180 min
effects on serum insulin concentrations after intake of test products at breakfast. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
0-180 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective appetite variables
Time Frame: 0-180 min
Subjective appetite variables (hunger, satiety, desire to eat) after intake of test products at breakfast, using a 100 mm Visual Analogue Scale (VAS) on a white paper. Except from a center mark in the center of the scale there was no other visible marks. Measurements were performed at fasting (time = 0 min) and at 15, 30, 45, 60, 90, 120, 150 and 180 min.
0-180 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Anne Nilsson, assoc. prof., Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 18, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Protokoll 2018/8-b

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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