Effects of Two Doses of Thylakoids on OGTT

Glucose Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702245
• Other study ID #: Thylakoid OGTT
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: May 12, 2017
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance

Intervention

Dietary Supplement:
• Experimental: Thylakoids 5 g
75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.
• Experimental: Thylakoids 10 g
75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.

Other:
• Placebo Comparator: Control
75 g pure glucose.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	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	p-GLP-1	Repeated blood sampling during three hours after an OGTT.	180 minutes, repeated at three occasions
Secondary	p-ghrelin	Repeated blood sampling during three hours after an OGTT.	180 minutes, repeated at three occasions