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Metabolic Responses to Glucose and Fructose supplementation in healthy individuals: a double-blind randomized crossover-controlled trial (MERGE1)

Metabolic Responses to Glucose and Fructose supplementation in healthy individuals: a double-blind randomized crossover-controlled trial (MERGE1) - MERGE1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024755
Enrollment
15
Registered
2021-06-11
Start date
2021-05-17
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Group 1: Ingestion of 1 g glucose per kgBW Group 2: Ingestion of 1 g fructose per kgBW Group 3: Ingestion of 0,5 g glucose + 0,5 g fructose per kgBW Group 4: Ingestion of 0,2 g sucralose

Sponsors

Universität Bayreuth Institut für Sportwissenschaften Division of Exercise Physiology and Metabolism
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - Informed consent obtained - Body mass index 18.0–29.9 kg/m2 (both inclusive) - Normal glucose tolerance (measured via overnight fasting blood glucose levels)

Exclusion criteria

Exclusion criteria: - Enrolment in other study - Known or suspected hypersensitivity to trial product(s) or related products Receipt of any investigational medicinal product within 1 week prior to screening in this trial -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) - Suffer from or history of a 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 the 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 excluded patients how have celiac 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. - Suffer from any chronic (metabolic) disorder or severe disease which, in the opinion of the Investigator might jeopardise participant’s safety or compliance with the protocol -heart rate <35 beats per minute (bpm) at screening (after resting for 5 min in supine position) - Supine blood pressure at screening (after resting for 5 min in supine position) outside the range of 90-150 mmHg for systolic or 50-95 mmHg for diastolic (excluding white-coat hypertension). - Significant abnormal ECG at screening, as judged by the Investigator - History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction - mental incapacity or language barriers precluding adequate understanding or cooperation - people who, in the opinion of their general practitioner or the Investigator, should not participate - Any condition that would interfere with trial participation or evaluation of results, as judged by the Investigator - Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods (including sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)

Design outcomes

Primary

MeasureTime frame
- Time in minutes until reaching peak blood glucose concentration in comparison of trial arms

Secondary

MeasureTime frame
- Time until peak blood glucose level following ingestion of study specific beverage in comparison of trial arms - Absolute and relative blood glucose level following ingestion of study specific beverage in comparison of trial arms - Peak blood lactate level following ingestion of study specific beverage in comparison of trial arms - Absolute and relative blood lactate level following ingestion of study specific beverage in comparison of trial arms - Peak insulin level following ingestion of study specific beverage in comparison of trial arms - Absolute and relative insulin level following ingestion of study specific beverage in comparison of trial arms - Peak glucagon level following ingestion of study specific beverage in comparison of trial arms - Absolute and relative glucagon level following ingestion of study specific beverage in comparison of trial arms - Peak c-peptide level following ingestion of study specific beverage in comparison of trial arms - Delta c-peptide level following ingestion of study specific beverage in comparison of trial arms - Change in fat oxidation following ingestion of study specific beverage in comparison of trial arms - Change in carbohydrate oxidation following ingestion of study specific beverage in comparison of trial arms - Change in heart rate variability in response to blood glucose levels and/or different glycaemic ranges following ingestion of study specific beverage in comparison of trial arms - Change in heart rate variability in response to rapid blood glucose excursions following ingestion of study specific beverage in comparison of trial arms

Countries

Germany

Contacts

Public ContactOthmar Moser

Division Exercise Physiology and Metabolism

othmar.moser@uni-bayreuth.de+49 (0)921 / 55-3465

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026