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Trial record 2 of 3 for:    appethyl

Effects of Two Doses of Thylakoids on OGTT

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ClinicalTrials.gov Identifier: NCT02702245
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Eva-Lena Stenblom, Region Skane

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.

Condition or disease Intervention/treatment Phase
Glucose Intolerance Dietary Supplement: Experimental: Thylakoids 5 g Dietary Supplement: Experimental: Thylakoids 10 g Other: Placebo Comparator: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers
Study Start Date : January 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2017

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 Name: 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 Name: Appethyl




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. p-GLP-1 [ Time Frame: 180 minutes, repeated at three occasions ]
    Repeated blood sampling during three hours after an OGTT.

  2. p-ghrelin [ Time Frame: 180 minutes, repeated at three occasions ]
    Repeated blood sampling during three hours after an OGTT.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702245


Sponsors and Collaborators
Region Skane
Lund University
Investigators
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Principal Investigator: Eva-Lena Stenblom, M.D. Lund University, Region Skane
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Responsible Party: Eva-Lena Stenblom, M.D., Region Skane
ClinicalTrials.gov Identifier: NCT02702245    
Other Study ID Numbers: Thylakoid OGTT
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases