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

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

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 Overview

• Status: Completed
• Conditions: Dysglycemia
• Intervention / Treatment: Dietary supplement: Glucose; Dietary supplement: MCE

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • Atlantia Food Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Glucose	Dietary supplement: Glucose; Ingestion of 15g glucose in water after min 10 hours of fasting
EXPERIMENTAL: MCE	Dietary supplement: MCE; Ingestion of 15g MCE in water after min 10 hours of fasting
EXPERIMENTAL: MCE + Glucose	Dietary supplement: Glucose; Ingestion of 15g glucose in water after min 10 hours of fasting; Dietary supplement: MCE; Ingestion of 15g MCE in water after min 10 hours of fasting

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Cambridge Glycoscience
• Collaborators: Atlantia Food Clinical Trials
• Investigators: Study Director: Thomas Nicholson, M.Phil; M.Sc, Cambridge Glycoscience; Principal Investigator: Timothy Dinan, M.D; Ph.D; D.Sc, Atlantia Food Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2020
• Primary Completion (ACTUAL): July 31, 2020
• Study Completion (ACTUAL): August 28, 2020

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (ACTUAL): March 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CG1142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No