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Completed

NCT Number: NCT04296045

A Study to Investigate the Effect of MCE on 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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Atlantia Food Clinical Trials

Cork, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MCE

Dietary Supplement

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

Glucose

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Difference in venous insulin from incremental area under the curve (iAUC) (T-15 to T120 minutes)

    Time frame: Through intervention periods of two hours

  2. Maximal concentrations for glucose and insulin (Cmax)

    Time frame: Through intervention periods of two hours

Sponsors and collaborators

Lead sponsor

Cambridge Glycoscience

Industry

Collaborators

  • Atlantia Food Clinical Trials

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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