Effects of Two Doses of Thylakoids on OGTT

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02702245

Enrollment

Registered

2016-03-08

Start date

2014-01-31

Completion date

2017-03-31

Last updated

2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Intolerance

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.

Interventions

DIETARY_SUPPLEMENTExperimental: Thylakoids 5 g

75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.

DIETARY_SUPPLEMENTExperimental: Thylakoids 10 g

75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.

OTHERPlacebo Comparator: Control

75 g pure glucose.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Insulin sensitivity	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

Measure	Time frame	Description
p-GLP-1	180 minutes, repeated at three occasions	Repeated blood sampling during three hours after an OGTT.
p-ghrelin	180 minutes, repeated at three occasions	Repeated blood sampling during three hours after an OGTT.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026