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

Sponsor

Cambridge Glycoscience (Industry)

Overall Status

Completed

CT.gov ID

NCT04296045

Collaborator

Atlantia Food Clinical Trials (Industry)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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. This is a randomised, double-blind, single-centre trial in 10 healthy male participants.

Condition or Disease	Intervention/Treatment	Phase
Dysglycemia	Dietary Supplement: MCE Dietary Supplement: Glucose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 2, 2020

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Aug 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Glucose	Dietary Supplement: Glucose Glucose
Experimental: MCE	Dietary Supplement: MCE MCE
Experimental: MCE + Glucose	Dietary Supplement: MCE MCE Dietary Supplement: Glucose Glucose

Arm

Intervention/Treatment

Placebo Comparator: Glucose

Dietary Supplement: Glucose

Glucose

Experimental: MCE

Dietary Supplement: MCE

MCE

Experimental: MCE + Glucose

Dietary Supplement: MCE

MCE

Dietary Supplement: Glucose

Glucose

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlantia Food Clinical Trials	Cork		Ireland

Sponsors and Collaborators

Cambridge Glycoscience
Atlantia Food Clinical Trials

Investigators

Study Director: Thomas Nicholson, M.Phil; M.Sc, Cambridge Glycoscience
Principal Investigator: Timothy Dinan, M.D; Ph.D; D.Sc, Atlantia Food Clinical Trials

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cambridge Glycoscience

ClinicalTrials.gov Identifier:

NCT04296045

Other Study ID Numbers:

CG1142

First Posted:

Mar 5, 2020

Last Update Posted:

Jun 18, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 18, 2021