NCT02702245

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

February 25, 2016

Last Update Submit

May 12, 2017

Conditions

Glucose Intolerance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • p-GLP-1

    180 minutes, repeated at three occasions

  • p-ghrelin

    180 minutes, repeated at three occasions

Study Arms (3)

Placebo comparator: Control

PLACEBO COMPARATOR

OGTT without thylakoids.

Other: Placebo Comparator: Control

Experimental: Thylakoids 5 g

EXPERIMENTAL

Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion.

Dietary Supplement: Experimental: Thylakoids 5 g

Experimental: Thylakoids 10 g

EXPERIMENTAL

Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion.

Dietary Supplement: Experimental: Thylakoids 10 g

Interventions

Experimental: Thylakoids 5 gDIETARY_SUPPLEMENT

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

Also known as: Appethyl
Experimental: Thylakoids 5 g
Experimental: Thylakoids 10 gDIETARY_SUPPLEMENT

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

Also known as: Appethyl
Experimental: Thylakoids 10 g
Placebo Comparator: ControlOTHER

75 g pure glucose.

Placebo comparator: Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Diabetes,
  • Impaired glucose tolerance and/or insulin resistance
  • Anaemia
  • Use of tobacco or drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eva-Lena Stenblom, M.D.

    Lund University, Region Skane

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 8, 2016

Study Start

January 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2017

Last Updated

May 15, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share