NCT04296045CompletedNot Applicable
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
Cambridge Glycoscience1 site in 1 country10 target enrollmentStarted: July 2, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
MCE
Experimental
Intervention: MCE (Dietary Supplement)
MCE + Glucose
Experimental
Intervention: MCE (Dietary Supplement)
Glucose
Active Comparator
Glucose
Intervention: Glucose (Dietary Supplement)
MCE + Glucose
Experimental
Intervention: Glucose (Dietary Supplement)
Outcomes
Primary Outcomes
Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes)
Time Frame: Through intervention periods of two hours
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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