Effects of Two Doses of Thylakoids on OGTT

Study Overview
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Brief Summary
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This cross-over intervention study aims to investigate the effect of two doses of thylakoids to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as appetite regulating hormones in healthy volunteers.

Detailed Description
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A minimum of twenty healthy volunteers are recruited to participate in an OGTT at three different occasions separated by one week. At two of the occasions a green leaf extract, thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. The third occasion, without added thylakoids, serve as control. Blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose load. Blood samples are analysed for p-glucose, p-insulin, p-C-peptide, p-ghrelin, p-CCK and p-GLP-1.

Official Title
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Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers

Conditions
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Glucose Intolerance

Intervention / Treatment
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* Dietary Supplement: Experimental: Thylakoids 5 g
* Dietary Supplement: Experimental: Thylakoids 10 g
* Other: Placebo Comparator: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Adult Normal-weight and weight stable Not pregnant or breast-feeding No use of medication that can affect glucose- and insulin homeostasis (for example corticosteroids). Exclusion Criteria: Diabetes, Impaired glucose tolerance and/or insulin resistance Anaemia Use of tobacco or drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo comparator: Control<br>OGTT without thylakoids. | Other: Placebo Comparator: Control<br>* 75 g pure glucose.<br>|
| Experimental: Experimental: Thylakoids 5 g<br>Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion. | Dietary Supplement: Experimental: Thylakoids 5 g<br>* 75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.<br>* Other names: Appethyl;|
| Experimental: Experimental: Thylakoids 10 g<br>Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion. | Dietary Supplement: Experimental: Thylakoids 10 g<br>* 75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.<br>* Other names: Appethyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Measurement of p-glucose, p-insulin and p-C-peptide in repeated blood sampling during three hours after an OGTT. | 180 minutes, repeated at three occasions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p-GLP-1 | Repeated blood sampling during three hours after an OGTT. | 180 minutes, repeated at three occasions | 
| p-ghrelin | Repeated blood sampling during three hours after an OGTT. | 180 minutes, repeated at three occasions |