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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Dysglycemia

Intervention / Treatment
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* Dietary Supplement: MCE
* Dietary Supplement: Glucose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Glucose<br>Glucose | Dietary Supplement: Glucose<br>* Ingestion of 15g glucose in water after min 10 hours of fasting<br>|
| Experimental: MCE<br> | Dietary Supplement: MCE<br>* Ingestion of 15g MCE in water after min 10 hours of fasting<br>|
| Experimental: MCE + Glucose<br> | Dietary Supplement: MCE<br>* Ingestion of 15g MCE in water after min 10 hours of fasting<br>Dietary Supplement: Glucose<br>* Ingestion of 15g glucose in water after min 10 hours of fasting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |