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

NCT04296045 | Completed DMC

• 1 other identifier: CG1142
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Difference in venous glucose from incremental area under the curve (iAUC) (T-15 to T120 minutes)

  Through intervention periods of two hours

Secondary Outcomes (2)

• 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

Study Arms (3)

Glucose

ACTIVE COMPARATOR

Glucose

Dietary Supplement: Glucose

MCE

EXPERIMENTAL

Dietary Supplement: MCE

MCE + Glucose

EXPERIMENTAL

Dietary Supplement: MCE; Dietary Supplement: Glucose

Interventions

MCE DIETARY_SUPPLEMENT

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

MCE; MCE + Glucose

Glucose DIETARY_SUPPLEMENT

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

Glucose; MCE + Glucose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cambridge Glycoscience: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Thomas Nicholson, M.Phil; M.Sc

  Cambridge Glycoscience

  STUDY DIRECTOR

• Timothy Dinan, M.D; Ph.D; D.Sc

  Atlantia Food Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: July 2, 2020
• Primary Completion: July 31, 2020
• Study Completion: August 28, 2020
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

IE (1)