Dysglycemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMCE
Ingestion of 15g MCE in water after min 10 hours of fasting
DIETARY_SUPPLEMENTGlucose
Ingestion of 15g glucose in water after min 10 hours of fasting
Sponsors
Atlantia Food Clinical Trials
Cambridge Glycoscience
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Ireland
Outcome results
None listed