Clinical trial NCT04296045: A Study to Investigate the Effect of MCE on Glucose and Insulin Responses in Healthy Males
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysglycemia
Lead sponsor: Cambridge Glycoscience
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2020-03-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes)
timeFrame: Through intervention periods of two hours
Secondary outcomes:
measure: Difference in venous insulin from incremental area under the curve (iAUC) (T-15 to T120 minutes)
timeFrame: Through intervention periods of two hours
measure: Maximal concentrations for glucose and insulin (Cmax)
timeFrame: Through intervention periods of two hours
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
affiliation: Cambridge Glycoscience
name: Thomas Nicholson, M.Phil; M.Sc
role: STUDY_DIRECTOR
affiliation: Atlantia Food Clinical Trials
name: Timothy Dinan, M.D; Ph.D; D.Sc
role: PRINCIPAL_INVESTIGATOR
References: