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Effect of Low Dose Galactose on Glycaemia and Glucose Kinetics

Effect of Low Dose Galactose on Glycaemia and Glucose Kinetics

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07599683
Acronym
GLOWS
Enrollment
25
Registered
2026-05-20
Start date
2026-01-01
Completion date
2029-12-31
Last updated
2026-07-08

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

Conditions

Glucose

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTgalactose

7.5 g galactose

DIETARY_SUPPLEMENTfructose

7.5 g fructose

DIETARY_SUPPLEMENTGlucose Powder

75 g glucose

Sponsors

University of Bath
Lead SponsorOTHER
University of Birmingham
CollaboratorOTHER
Arla Foods
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age: 18 years and above; * Normoglycaemic (fasting glucose \<6.1 mmol/L) * Body mass index: 18.5-30 kg/m2

Exclusion criteria

* 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; * dietary intolerances or allergies, or to any other study procedures; * disorders in the ability to metabolise galactose or fructose (e.g., galactosemias); * diagnosis of any gastrointestinal disorders; * any other condition/medications that could introduce bias; * unable to understand and follow study procedures

Design outcomes

Primary

MeasureTime frameDescription
Glucose incremental area under the curve180 minutesDifference in glucose concentration incremental area under the curve between treatments over a 180-minute postprandial period.
Plasma glucose kinetics180 minutesDifference 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.
Oxidative and non-oxidative fate of ingested glucose180 minutesDifference in oxidative and non-oxidative fate of ingested glucose between treatments over a 180-minute postprandial period.

Secondary

MeasureTime frameDescription
Glucoregulatory and metabolite concentrations180 minutesDifference 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.
Whole-body carbohydrate and fat oxidation180 minutesDifference in whole-body carbohydrate and fat oxidation rates between treatments over a 180-minute postprandial period.

Countries

United Kingdom

Contacts

CONTACTLucy Merrell, PhD
lhm31@bath.ac.uk+441225385518
CONTACTJavier T Gonzalez, PhD
j.t.gonzalez@bath.ac.uk+441225385518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026