Status:
COMPLETED
A Study to Investigate the Effect of MCE on Glucose and Insulin Responses in Healthy Males
Lead Sponsor:
Cambridge Glycoscience
Collaborating Sponsors:
Atlantia Food Clinical Trials
Conditions:
Dysglycemia
Eligibility:
MALE
18-60 years
Phase:
NA
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 glu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04296045
Start Date
July 2 2020
End Date
August 28 2020
Last Update
October 19 2022
Active Locations (1)
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1
Atlantia Food Clinical Trials
Cork, Ireland