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Completed

NCT Number: NCT02702245

Effects of Two Doses of Thylakoids on OGTT

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.

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Key information

Conditions

Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Thylakoids 5 g

Dietary Supplement

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

Other names: Appethyl

Experimental: Thylakoids 10 g

Dietary Supplement

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

Other names: Appethyl

Placebo Comparator: Control

Other

75 g pure glucose.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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