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| ID | Type | Description | Link |
|---|---|---|---|
| UKRI/BB/C001910/1 | Other Grant/Funding Number | BBSRC and Arla Foods Ingredients |
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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
| Arla Foods | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL | Sham Comparator | 75 g oral glucose tolerance test |
|
| GALACTOSE | Experimental | 75 g oral glucose tolerance test plus 7.5 g galactose |
|
| FRUCTOSE | Active Comparator | 75 g oral glucose tolerance test plus 7.5 g fructose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galactose | Dietary Supplement | 7.5 g galactose |
| |
| fructose |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose incremental area under the curve | Difference in glucose concentration incremental area under the curve between treatments over a 180-minute postprandial period. | 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. | 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. | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 180 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucy Merrell, PhD | Contact | +441225385518 | lhm31@bath.ac.uk | |
| Javier T Gonzalez, PhD | Contact | +441225385518 | j.t.gonzalez@bath.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bath | Recruiting | Bath | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32297937 | Background | 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. |
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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.
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| ID | Term |
|---|---|
| D005690 | Galactose |
| D005632 | Fructose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 |
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| Dietary Supplement |
7.5 g fructose |
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| Glucose Powder | Dietary Supplement | 75 g glucose |
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| 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. | 180 minutes |
| Ketoses |