search
Back to results

Effects of Two Doses of Thylakoids on OGTT

Primary Purpose

Glucose Intolerance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: Thylakoids 5 g
Experimental: Thylakoids 10 g
Placebo Comparator: Control
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Arm Label

    Placebo comparator: Control

    Experimental: Thylakoids 5 g

    Experimental: Thylakoids 10 g

    Arm Description

    OGTT without thylakoids.

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

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

    Outcomes

    Primary Outcome Measures

    Insulin sensitivity
    Measurement of p-glucose, p-insulin and p-C-peptide in repeated blood sampling during three hours after an OGTT.

    Secondary Outcome Measures

    p-GLP-1
    Repeated blood sampling during three hours after an OGTT.
    p-ghrelin
    Repeated blood sampling during three hours after an OGTT.

    Full Information

    First Posted
    February 25, 2016
    Last Updated
    May 12, 2017
    Sponsor
    Region Skane
    Collaborators
    Lund University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02702245
    Brief Title
    Effects of Two Doses of Thylakoids on OGTT
    Official Title
    Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Region Skane
    Collaborators
    Lund University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucose Intolerance

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo comparator: Control
    Arm Type
    Placebo Comparator
    Arm Description
    OGTT without thylakoids.
    Arm Title
    Experimental: Thylakoids 5 g
    Arm Type
    Experimental
    Arm Description
    Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion.
    Arm Title
    Experimental: Thylakoids 10 g
    Arm Type
    Experimental
    Arm Description
    Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Experimental: Thylakoids 5 g
    Other Intervention Name(s)
    Appethyl
    Intervention Description
    75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Experimental: Thylakoids 10 g
    Other Intervention Name(s)
    Appethyl
    Intervention Description
    75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo Comparator: Control
    Intervention Description
    75 g pure glucose.
    Primary Outcome Measure Information:
    Title
    Insulin sensitivity
    Description
    Measurement of p-glucose, p-insulin and p-C-peptide in repeated blood sampling during three hours after an OGTT.
    Time Frame
    180 minutes, repeated at three occasions
    Secondary Outcome Measure Information:
    Title
    p-GLP-1
    Description
    Repeated blood sampling during three hours after an OGTT.
    Time Frame
    180 minutes, repeated at three occasions
    Title
    p-ghrelin
    Description
    Repeated blood sampling during three hours after an OGTT.
    Time Frame
    180 minutes, repeated at three occasions

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eva-Lena Stenblom, M.D.
    Organizational Affiliation
    Lund University, Region Skane
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Two Doses of Thylakoids on OGTT

    We'll reach out to this number within 24 hrs