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NCT Number: NCT07599683

Effect of Low Dose Galactose on Glycaemia and Glucose Kinetics

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galactose

Dietary Supplement

7.5 g galactose

Fructose

Dietary Supplement

7.5 g fructose

Glucose Powder

Dietary Supplement

75 g glucose

Primary outcomes

  1. Glucose incremental area under the curve

    Time frame: 180 minutes

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

  2. Plasma glucose kinetics

    Time frame: 180 minutes

    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.

  3. Oxidative and non-oxidative fate of ingested glucose

    Time frame: 180 minutes

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

Secondary outcomes

  1. Glucoregulatory and metabolite concentrations

    Time frame: 180 minutes

    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.

  2. Whole-body carbohydrate and fat oxidation

    Time frame: 180 minutes

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

Other outcomes

  1. Other analyte concentrations

    Time frame: 180 minutes

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Javier T Gonzalez, PhD

CONTACT

[email protected]

+441225385518

Lucy Merrell, PhD

CONTACT

[email protected]

+441225385518

Sponsors and collaborators

Lead sponsor

University of Bath

Other

Collaborators

  • Arla Foods
  • University of Birmingham

Registry information

Acronym: GLOWS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
May 20, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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