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
About this trial
This is an interventional basic science trial for Glucose Intolerance
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.
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
NCT ID
NCT02702245
First Posted
February 25, 2016
Last Updated
May 12, 2017
Sponsor
Region Skane
Collaborators
Lund University
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
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Effects of Two Doses of Thylakoids on OGTT
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