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RecruitingNCT07599683GLOWSUpdated Jul 8, 2026

Effect of Low Dose Galactose on Glycaemia and Glucose Kinetics

An interventional study of galactose and fructose in Glucose, sponsored by University of Bath. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by University of Bath · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glucose
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Sham comparator
    CONTROL

    75 g oral glucose tolerance test

    Dietary Supplement: Glucose Powder

  • Experimental
    GALACTOSE

    75 g oral glucose tolerance test plus 7.5 g galactose

    Dietary Supplement: galactose · Dietary Supplement: Glucose Powder

  • Active comparator
    FRUCTOSE

    75 g oral glucose tolerance test plus 7.5 g fructose

    Dietary Supplement: fructose · Dietary Supplement: Glucose Powder

Interventions

  • Dietary supplementgalactose

    7.5 g galactose

  • Dietary supplementfructose

    7.5 g fructose

  • Dietary supplementGlucose Powder

    75 g glucose

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

  1. 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

06

Study locations

1 of 1 sites recruiting
  • University of Bath
    Bath, United Kingdom
    Recruiting
07

References and documents

Publications

  • Watkins J, Simpson A, Betts JA, Thompson D, Holliday A, Deighton K, Gonzalez JT. Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men. J Nutr. 2020 Jul 1;150(7):1765-1772. doi: 10.1093/jn/nxaa105. PubMed 32297937 ↗

Individual participant data

Plan to share: Yes — IPD will be shared via the University of Bath data repository in deidentified form at the point of publication of the primary outcome in a peer-reviewed journal.

Supporting information: Study protocol, Sap, Icf, Analytic code

08

Registry details

Key details

Study ID
NCT07599683
Lead sponsor
University of Bath
Collaborators
University of Birmingham, Arla Foods
Responsible party
Javier Gonzalez (Professor of Nutrition and Metabolism, University of Bath) — Principal investigator
First posted
May 20, 2026
Start date
Jan 1, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jul 8, 2026

Study contacts

Lucy Merrell, PhD
Contact
lhm31@bath.ac.uk
+441225385518
Javier T Gonzalez, PhD
Contact
j.t.gonzalez@bath.ac.uk
+441225385518

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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