Glucose IntoleranceNCT02702245
Effects of Two Doses of Thylakoids on OGTT
A study testing Experimental: Thylakoids 5 g and Experimental: Thylakoids 10 g in people with Glucose Intolerance, run by Region Skane.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Intolerance
- What is being tested?
- Experimental: Thylakoids 5 g and Experimental: Thylakoids 10 g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Diabetes,
- Impaired glucose tolerance and/or insulin resistance
- Anaemia
- Use of tobacco or drugs.
About this study
Official title: Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers
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.
Read the 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.
- Conditions
- Glucose Intolerance
- Being tested
- Experimental: Thylakoids 5 g, Experimental: Thylakoids 10 g, Placebo Comparator: Control
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Thylakoids 5 gDietary supplement
Also called Appethyl
75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.
Experimental: Thylakoids 10 gDietary supplement
Also called Appethyl
75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.
Placebo Comparator: ControlOther
75 g pure glucose.
| Study group | Role | What they receive |
|---|---|---|
| Placebo comparator: Control | Placebo comparator | OGTT without thylakoids. Receives: Other: Placebo Comparator: Control |
| Experimental: Thylakoids 5 g | Experimental | Intervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion. Receives: 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. Receives: Dietary Supplement: Experimental: Thylakoids 10 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measurement of p-glucose, p-insulin and p-C-peptide in repeated blood sampling during three hours after an OGTT.
Measured: 180 minutes, repeated at three occasions
Secondary outcomes (2)
p-GLP-1
Repeated blood sampling during three hours after an OGTT.
Measured: 180 minutes, repeated at three occasions
p-ghrelin
Repeated blood sampling during three hours after an OGTT.
Measured: 180 minutes, repeated at three occasions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose IntoleranceStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Eva-Lena Stenblom, Region Skane
- Investigators
- Eva-Lena Stenblom, M.D., Principal investigator, Lund University, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702245
- Sponsor's protocol ID
- Thylakoid OGTT
- Status last verified
- May 2017
- First submitted
- 25 Feb 2016
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thylakoids' Effect on Glucose Homeostasis and Appetite Regulation After an Oral Glucose Tolerance Test in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02702245
- Acronym / sponsor ID
- Thylakoid OGTT
- Conditions
- Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo comparator: Control | Placebo comparator | Other: Placebo Comparator: ControlOGTT without thylakoids. |
| Experimental: Thylakoids 5 g | Experimental | Dietary Supplement: Experimental: Thylakoids 5 gIntervention type: Dietary supplement. Supplement: thylakoid powder, dose 5 g. Intervention: OGTT at one occasion. |
| Experimental: Thylakoids 10 g | Experimental | Dietary Supplement: Experimental: Thylakoids 10 gIntervention type: Dietary supplement. Supplement: thylakoid powder, dose 10 g. Intervention: OGTT at one occasion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Diabetes,
- Impaired glucose tolerance and/or insulin resistance
- Anaemia
- Use of tobacco or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Thylakoids 5 gAlso: Appethyl75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder. | Dietary supplement | Experimental: Thylakoids 5 g |
| Experimental: Thylakoids 10 gAlso: Appethyl75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder. | Dietary supplement | Experimental: Thylakoids 10 g |
| Placebo Comparator: Control75 g pure glucose. | Other | Placebo comparator: Control |
Primary outcome
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.
2 secondary outcomes
p-GLP-1
Time frame: 180 minutes, repeated at three occasions
p-ghrelin
Time frame: 180 minutes, repeated at three occasions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva-Lena Stenblom, M.D. principal investigator
Lund University, Region Skane
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Thylakoids 5 g and Experimental: Thylakoids 10 g in people with Glucose Intolerance, run by Region Skane.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 180 minutes, repeated at three occasions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.