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

Dysglycemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296045
• Other study ID #: CG1142
• Status: Completed
• Phase: N/A
• Start date: July 2, 2020
• Est. completion date: August 28, 2020

Study information

• Verified date: October 2022
• Source: Cambridge Glycoscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 28, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysglycemia

Intervention

Dietary Supplement:
• MCE
Ingestion of 15g MCE in water after min 10 hours of fasting
• Glucose
Ingestion of 15g glucose in water after min 10 hours of fasting

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge Glycoscience	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

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