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

NCT ID: NCT04296045

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2020-08-28

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.

Conditions

Dysglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Glucose

Glucose

Group Type: ACTIVE_COMPARATOR

Glucose

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of 15g glucose in water after min 10 hours of fasting

MCE

Group Type: EXPERIMENTAL

MCE

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of 15g MCE in water after min 10 hours of fasting

MCE + Glucose

Group Type: EXPERIMENTAL

MCE

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of 15g MCE in water after min 10 hours of fasting

Glucose

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of 15g glucose in water after min 10 hours of fasting

Interventions

MCE

Ingestion of 15g MCE in water after min 10 hours of fasting

Intervention Type: DIETARY_SUPPLEMENT

Glucose

Ingestion of 15g glucose in water after min 10 hours of fasting

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

Cambridge Glycoscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Nicholson, M.Phil; M.Sc

Role: STUDY_DIRECTOR

Cambridge Glycoscience

Timothy Dinan, M.D; Ph.D; D.Sc

Role: PRINCIPAL_INVESTIGATOR

Atlantia Food Clinical Trials

Locations

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

Ireland

Other Identifiers

CG1142

Identifier Type: -

Identifier Source: org_study_id