The Metabolic Effects of Ultra-endurance Exercise and Training Under Low or High Glycaemic Index-carbohydrate Diets.

NCT05519800 | Completed

• 1 other identifier: U1111-1281-5048
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A randomised counter-balanced intervention study in endurance athletes

Conditions

A Randomised Counter-balanced Intervention Study in Endurance Athletes

Outcome Measures

Primary Outcomes (1)

• Interstitial Glucose Percentage Coefficient of Variation.

  A metric which is related to the daily variation of Interstitial Glucose concentration relative to mean concentration.

  24 months

Secondary Outcomes (7)

• Mean blood and interstitial glucose concentration.

  24 Months

• % Time Spent in Range

  24 Months

• Performance changes

  24 Months

• Cardio vascular indicators during exercise

  24 Months

• Metabolic and hormonal change in response to re-feed of high or low glycaemic carbohydrate.

  24 Months

Study Arms (2)

High Glycaemic Index

ACTIVE COMPARATOR

A diet comprising of High Glycaemic Carbohydrate. Supplemented with a maltodextrin containing beverage.

Dietary Supplement: Maltodextrin

Low Glycaemic Index

EXPERIMENTAL

A diet comprising of Low Glycaemic Carbohydrate. Supplemented with an Isomaltulose containing beverage.

Dietary Supplement: Isomaltulose

Interventions

Isomaltulose DIETARY_SUPPLEMENT

Diet will be supplemented with a beverage containing Isomaltulose as a carbohydrate source.

Also known as: Palatinose

Low Glycaemic Index

Maltodextrin DIETARY_SUPPLEMENT

Diet will be supplemented using a beverage containing Maltodextrin.

High Glycaemic Index

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained
• Male or female aged 18-65 years (both inclusive)
• Otherwise healthy (as judged by premedical questionnaire) and participating in regular training (volume in training \>10 h training per week) and participating in endurance events and/or VO2max \> 55 ml.kg-1.min-1.

You may not qualify if:

• Receipt of any investigational medicinal product within 1 month prior to screening in this trial
• Haemoglobin \<8.0 mmol/L (male) or \<7.0 mmol/L (female).
• Systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone and non-routine vitamins and herbal products. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months.
• Suffer from or history of a life-threatening disease (i.e. cancer judged not to be in full remission except basal cell skin cancer or squamous cell skin cancer), or clinically severe diseases that directly influence the study results, as judged by the Investigator. This does not prohibit the participation of patients taking medications that influences their metabolism (e.g. statin) or cardio- respiratory system (e.g. asthma spray) as long as the therapy is stable and is not adapted throughout the run of the trial. Furthermore, it does not exclude patients how have coeliac disease (or similar diseases or allergies), as long as the disease is stable, and patients are able to stay on their specific (e.g.) gluten- free diet.
• Known cardiac problems defined as decompensated heart failure (New York Heart Association (NYHA) class III and IV) 10 at any time and/or angina pectoris within the last 12 months and/or acute myocardial infarction at any time
• History of clinically significant abnormal ECG issues, as judged by the Investigator.
• Severe retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
• Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise participant's safety or compliance with the protocol.
• History of allergies and/or intolerances to drugs or foods or a history of severe anaphylactic reaction e.g. fructose intolerance.
• Significant history of alcoholism or drug/chemical abuse as per Investigator's judgement or a positive result in the urine drug/alcohol screen at the screening Visit.
• Smoker (defined as a participant who is smoking more than 5 cigarettes or the equivalent per day).
• Not able or willing to refrain from smoking or use of nicotine substitute products during the monitoring period.
• Participant with mental incapacity or language barriers precluding adequate understanding or cooperation or who, in the opinion of their general practitioner or the Investigator, should not participate in the trial.
• Participating in any other research trial which may interfere with the current study.
• Potentially non-compliant or uncooperative during the trial, as judged by the Investigator.

Sponsors & Collaborators

• Swansea University: lead
• Beneo GmbH: collaborator

Study Sites (1)

Swansea Univeristy

Swansea, SA28PP, United Kingdom

Location

MeSH Terms

Interventions

isomaltulose; maltodextrin

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomised counter-balanced

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 29, 2022
• Study Start: October 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: November 22, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Locations

GB (1)