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

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

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

Conditions
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Glucose Tolerance, Appetite Sensations

Intervention / Treatment
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* Dietary Supplement: Nopal fractions
* Dietary Supplement: Test product without the active components


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomised crossover study in healthy young adults with normal BMI
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial glucose tolerance | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy subjects, diabetes prevention, obesity prevention