Effect of Low Dose Galactose on Glycaemia and Glucose Kinetics

ConditionGlucose

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Bath

About this trial

This project will establish the degree to which adding low-dose galactose to a meal can control blood sugar levels. People will consume standardised glucose drinks (75g glucose, as an oral glucose tolerance test). People will consume these with and without the addition of galactose, and with the addition of another sugar (fructose) for an extra comparison. The investigators will use state-of-the-art labelling methods (dual stable isotope technology) to follow what happens to the glucose that is ingested and understand what happens to sugar being released by the liver and sugar being taken up by other tissues like the muscles. These methods can tell the investigators how the addition of galactose can control blood sugar levels. For example, the galactose could slow down the appearance of glucose from the gut and/or liver released into the blood, or it could increase the disappearance of glucose from the blood into muscles. The investigators will measure the appearance of the label on exhaled breath, which will establish whether ingested sugar is stored, or burned as fuel. The investigators will also explore other potential ways in which galactose might control blood sugar levels by measuring key hormones and metabolites that contribute to blood sugar control (for example, insulin, fatty acids, and incretin hormones which potentiate insulin secretion). This additional evidence of how galactose can control blood sugar levels will provide the understanding required to best make use of this approach across a variety of settings.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: 18 years and above;

Normoglycaemic (fasting glucose <6.1 mmol/L)

Body mass index: 18.5-30 kg/m2

Disqualifiers

weight instability (>5% change within last 3 months);

pregnant or lactating;

following a very low-carbohydrate (ketogenic) diet;

diagnosis of diabetes or prediabetes, or any other metabolic disease;

Trial design

Design model

Crossover

Treatments tested in this trial

galactose
Dietary supplement
7.5 g galactose
fructose
Dietary supplement
7.5 g fructose
Glucose Powder
Dietary supplement
75 g glucose

Treatment groups

25 Participants

are divided into 3 treatment groups

Group A: CONTROLSham comparator 1 intervention

Group B: GALACTOSEExperimental treatment 2 interventions

Group C: FRUCTOSEActive comparator 2 interventions

Trial outcomes

Primary outcomes

Glucose incremental area under the curve

Difference in glucose concentration incremental area under the curve between treatments over a 180-minute postprandial period.

Time frame

180 minutes

Plasma glucose kinetics

Difference in plasma glucose kinetics (rate of total glucose appearance, rate of endogenous glucose appearance, rate of exogenous glucose appearance, rate of glucose disappearance and glucose metabolic clearance rate) between treatments over a 180-minute postprandial period.

Time frame

180 minutes

Oxidative and non-oxidative fate of ingested glucose

Difference in oxidative and non-oxidative fate of ingested glucose between treatments over a 180-minute postprandial period.

Time frame

180 minutes

Secondary outcomes

Glucoregulatory and metabolite concentrations

Difference in glucoregulatory hormone and metabolite incremental area under the curve between treatments over a 180-minute postprandial period, with the following metabolites and hormones: Insulin, C-peptide Glucagon, Glucose-dependent insulinotropic polypeptide (GIP), Glucagon-like peptide-1 (GLP-1), Non-esterified fatty acids (NEFA), Glycerol, Uric acid, Triacylglycerol. Oxygen saturation, pH, Bicarbonate.

Time frame

180 minutes

Whole-body carbohydrate and fat oxidation

Difference in whole-body carbohydrate and fat oxidation rates between treatments over a 180-minute postprandial period.

Time frame

180 minutes

Other outcomes

Other analyte concentrations

Difference in hormone and analyte concentrations during the postprandial period, adjusted for baseline, with the following analytes: Fructose Galactose Low-density lipoprotein cholesterol High-density lipoprotein cholesterol C-reactive protein Aspartate transaminase Alanine aminotransferase

Time frame

180 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bath

Lead sponsor

University of Birmingham

Collaborator

Arla Foods

Collaborator

Source ClinicalTrials.gov

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