Effects of Two Doses of Thylakoids on OGTT

May 12, 2017 updated by: Eva-Lena Stenblom, Region Skane

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

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 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo comparator: Control
OGTT without thylakoids.
Other: Placebo Comparator: Control
75 g pure glucose.
EXPERIMENTAL: Experimental: Thylakoids 5 g
Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion.
Dietary supplement: Experimental: Thylakoids 5 g
75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.
Other Names:
  • Appethyl
EXPERIMENTAL: Experimental: Thylakoids 10 g
Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion.
Dietary supplement: Experimental: Thylakoids 10 g
75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.
Other Names:
  • Appethyl

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Region Skane

Collaborators

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

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

February 25, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (ESTIMATE)

March 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 15, 2017

Last Update Submitted That Met QC Criteria

May 12, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thylakoid OGTT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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