Effects of Two Doses of Thylakoids on OGTT

NCT ID: NCT02702245

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-03-31

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.

Conditions

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Glucose Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo comparator: Control

OGTT without thylakoids.

Group Type PLACEBO_COMPARATOR

Placebo Comparator: Control

Intervention Type OTHER

75 g pure glucose.

Experimental: Thylakoids 5 g

Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion.

Group Type EXPERIMENTAL

Experimental: Thylakoids 5 g

Intervention Type DIETARY_SUPPLEMENT

75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.

Experimental: Thylakoids 10 g

Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion.

Group Type EXPERIMENTAL

Experimental: Thylakoids 10 g

Intervention Type DIETARY_SUPPLEMENT

75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.

Interventions

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Experimental: Thylakoids 5 g

75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.

Intervention Type DIETARY_SUPPLEMENT

Experimental: Thylakoids 10 g

75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.

Intervention Type DIETARY_SUPPLEMENT

Placebo Comparator: Control

75 g pure glucose.

Intervention Type OTHER

Other Intervention Names

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Appethyl Appethyl

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Eva-Lena Stenblom

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva-Lena Stenblom, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lund University, Region Skane

Other Identifiers

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Thylakoid OGTT

Identifier Type: -

Identifier Source: org_study_id

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