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

Cambridge Glycoscience

Status: Completed

Conditions: Dysglycemia

Treatments: Dietary Supplement: Glucose; Dietary Supplement: MCE

Study type: Interventional

Funder types: Industry

Identifiers

NCT04296045

CG1142

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 3 patient groups

Glucose

Active Comparator group

Description:

Glucose

Treatment:

Dietary Supplement: Glucose

MCE

Experimental group

Treatment:

Dietary Supplement: MCE

MCE + Glucose

Experimental group

Treatment:

Dietary Supplement: Glucose

Dietary Supplement: MCE