DysglycemiaNCT04296045

A Study to Investigate the Effect of MCE on Glucose and Insulin Responses in Healthy Males

A study testing MCE and Glucose in people with Dysglycemia, run by Cambridge Glycoscience at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Maize Cob Extract (MCE) is intended to be used as a bulking agent in food. The purpose of this study is to determine the glycaemic and insulinemic response of MCE consumed in isolation compared to glucose; the glycaemic and insulinemic response will also be determined for MCE alone and in combination with glucose. Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Dysglycemia
What is being tested?: MCE and Glucose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteIreland
Study dates: 2 Jul 2020to 28 Aug 2020
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 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Be able to give written informed consent;
Be between 18 and 60 years of age inclusive;
Have a body mass index <30 Kg/m2;
Have a fasting glucose level of ≤6.0 mmol/L
Be in general good health, as determined by the investigator;
Be willing to fast for at least 10 hours before the study visit.

Who cannot join

The presence of any of the following criteria will exclude the participant from participating in the study:
Are less than 18 or greater than 60 years of age;
Recent gastroenteritis or food borne illness such as confirmed food poisoning within the past 4 weeks;
Have taken a medication or dietary supplement that may influence GI activity within the 2-weeks prior to screening;
Have a history of abdominal surgery (excluding appendectomy);
Have taken anaesthesia within the past 4 weeks;

Show all 20Show fewer

Have taken antibiotics within the past 12-weeks;
Have a recent history of drug and/or alcohol abuse at the time of enrolment;
Are a smoker (defined as >5 cigarettes/week);
Have made any major dietary change in the past 3 months;
Have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
Have an active gastrointestinal disorder or previous gastrointestinal surgery;
Have irritable bowel syndrome, diagnosed or undiagnosed and treated with chronic medications;
Have a metabolic or endocrine disorder such as diabetes, thyroidism, or other metabolic disorder;
Have a severe chronic disease i.e. cancer, renal failure, hepatitis, HIV, cirrhosis etc., or with a history of such diseases;
Have a gastrointestinal disease i.e., chronic diarrhoea, Crohn's disease, ulcerative colitis, diverticulosis, stomach or duodenal ulcers, or with a history of such diseases;
Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a systemic steroid for >30 days, or chemotherapy or radiotherapy within the last year);
Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
Participants who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
Participant is currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study

Trial locations and contacts

1 site in 1 country.

Ireland1 site

Atlantia Food Clinical Trials
Cork

Other trials in Ireland

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Cross-over Study, to Investigate the Effect of Maize Cob Extract on Post-prandial Glucose and Insulin Responses in Healthy Males

Conditions: Dysglycemia
Being tested: MCE, Glucose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MCEDietary supplement
Ingestion of 15g MCE in water after min 10 hours of fasting
GlucoseDietary supplement
Ingestion of 15g glucose in water after min 10 hours of fasting

Study groups in NCT04296045
Study group	Role	What they receive
Glucose	Active comparator	Glucose Receives: Dietary Supplement: Glucose
MCE	Experimental	Not described Receives: Dietary Supplement: MCE
MCE + Glucose	Experimental	Not described Receives: Dietary Supplement: MCE; Dietary Supplement: Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes)
Measured: Through intervention periods of two hours

Secondary outcomes (2)

Difference in venous insulin from incremental area under the curve (iAUC) (T-15 to T120 minutes)
Measured: Through intervention periods of two hours
Maximal concentrations for glucose and insulin (Cmax)
Measured: Through intervention periods of two hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jul 202028 Aug 2020

First posted5 Mar 2020
Study start2 Jul 2020
Primary completion31 Jul 2020
Study completion28 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DysglycemiaStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04296045
Sponsor's protocol ID: CG1142
Status last verified: Oct 2022
First submitted: 3 Mar 2020
Last updated: 19 Oct 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)
Dysglycemia
Active, not recruiting
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Dysglycemia
Enrolling by invitation
Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
Gestational Diabetes
Not yet recruitingPhase 2
Verapamil Effect in Cystic Fibrosis-related Dysglycemia
Cystic Fibrosis Related Diabetes, Cystic Fibrosis (CF)
Not yet recruitingPhase 2
Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
Type 1 Diabetes (T1D)

All Dysglycemia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Cross-over Study, to Investigate the Effect of Maize Cob Extract on Post-prandial Glucose and Insulin Responses in Healthy Males
ClinicalTrials.gov ID: NCT04296045
Acronym / sponsor ID: CG1142
Conditions: Dysglycemia
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Cambridge GlycoscienceIndustry (pharma, biotech, devices)
Collaborators: Atlantia Food Clinical Trials
Study start: 2 Jul 2020 (actual)
Primary completion: 31 Jul 2020 (actual)
Study completion: 28 Aug 2020 (actual)
First posted: 5 Mar 2020 (actual)
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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Glucose	Active comparator	Dietary Supplement: GlucoseGlucose
MCE	Experimental	Dietary Supplement: MCE
MCE + Glucose	Experimental	Dietary Supplement: MCE, Dietary Supplement: Glucose

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Be able to give written informed consent;
Be between 18 and 60 years of age inclusive;
Have a body mass index <30 Kg/m2;
Have a fasting glucose level of ≤6.0 mmol/L
Be in general good health, as determined by the investigator;

Key exclusion criteria (20 listed)

The presence of any of the following criteria will exclude the participant from participating in the study:
Are less than 18 or greater than 60 years of age;
Recent gastroenteritis or food borne illness such as confirmed food poisoning within the past 4 weeks;
Have taken a medication or dietary supplement that may influence GI activity within the 2-weeks prior to screening;
Have a history of abdominal surgery (excluding appendectomy);

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
MCEIngestion of 15g MCE in water after min 10 hours of fasting	Dietary supplement	MCE, MCE + Glucose
GlucoseIngestion of 15g glucose in water after min 10 hours of fasting	Dietary supplement	Glucose, MCE + Glucose

Primary outcome

Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes)
Time frame: Through intervention periods of two hours

2 secondary outcomes

Difference in venous insulin from incremental area under the curve (iAUC) (T-15 to T120 minutes)
Time frame: Through intervention periods of two hours
Maximal concentrations for glucose and insulin (Cmax)
Time frame: Through intervention periods of two hours

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 19 Oct 2022.
Individual participant dataSharing planned: Undecided

Related trials for Dysglycemia

Not yet recruitingObservational study
Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)
Dysglycemia
Active, not recruiting
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, Dysglycemia
Enrolling by invitation
Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening
Gestational Diabetes
Not yet recruitingPhase 2
Verapamil Effect in Cystic Fibrosis-related Dysglycemia
Cystic Fibrosis Related Diabetes, Cystic Fibrosis (CF)
Not yet recruitingPhase 2
Platform Trial in Stage 1 Diabetes: Comparing Golimumab vs Placebo
Type 1 Diabetes (T1D)

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.

Thomas Nicholson, M.Phil; M.Sc study director

Cambridge Glycoscience

Timothy Dinan, M.D; Ph.D; D.Sc principal investigator

Atlantia Food Clinical Trials

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MCE and Glucose in people with Dysglycemia, run by Cambridge Glycoscience at 1 site in Ireland.

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 6 inclusion and 20 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 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes) (time frame: Through intervention periods of two hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04296045.

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 19 Oct 2022.