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| Name | Class |
|---|---|
| Norfolk and Norwich University Hospitals NHS Foundation Trust | OTHER |
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Broccoli has shown to normalise elevated blood sugars when eaten over long period of time. Individuals with pre-diabetes have higher than normal blood sugar levels. In this study, investigators are trying to understand how broccoli, when eaten as a soup, affects blood sugar levels in individuals with pre-diabetes.
The BETA study is a 36-week randomized, double-blind, placebo-controlled, two-arm crossover intervention study conducted at the Quadram Institute Clinical Research Facility (QI CRF), Norwich, UK. Investigators are seeking adults with pre-diabetes, to determine whether broccoli soups affect glucose metabolism, compared to a similar soup containing courgette. There are a total of 9 clinical visits (1 screening visit, 4 short visits, and 4 oral glucose tolerance testing visits). Investigators will assess blood samples for glycated hemoglobin (HbA1c), fasting plasma glucose, insulin, fructosamine, cholesterol and triglycerides. Investigators will also quantify the metabolites in urine through analytical analysis and determine whether gene expression is altered by the soups through RNA sequencing. Participants will consume one of two soups (broccoli or courgette) for the first intervention period then after a twelve-week washout phase (soup holiday), participants will crossover and consume the other soup for the second intervention period. For each intervention period, soups will be consumed three times a week per twelve-week period. Investigators will ask the participant to complete lifestyle questionnaires regarding their physical activity and dietary pattern.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Broccoli soup | Experimental | The soup will be made with a commercially available dried vegetable soup supplemented with broccoli powder. |
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| Courgette soup | Sham Comparator | The soup will be made with a commercially available dried vegetable soup supplemented with courgette powder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Broccoli soup | Other | Participants will consume one broccoli soup three times a week for one 12-week intervention period as part of their normal diet. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated haemoglobin (HbA1c) after broccoli and courgette soup interventions | Comparison of fasting blood for HbA1c at baseline and after soup interventions | Week: 0, 12, 24 and 36. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postprandial capillary glucose concentration | Capillary glucose concentration will be measured by finger prick after administration of a glucose challenge using a standardized 75g glucose beverage (GlucosePro). Measurements will be taken -15, -10, -5, 15, 30, 45, 60, 90, 120, 150, 180, 210 min post glucose beverage at Week: 0, 12, 24 and 36. | 3.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
The participant will not be able to take part if they('re):
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| Name | Affiliation | Role |
|---|---|---|
| Paul A Kroon, PhD | Quadram Institute Bioscience | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quadram Institute Bioscience | Norwich | NR4 7UQ | United Kingdom |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2022 | Feb 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Crossover Assignment
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Double blind masking
| Courgette soup | Other | Participants will consume one courgette soup three times a week for one 12-week intervention period as part of their normal diet. |
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| Change in fasting plasma glucose (mmol/l) after broccoli and courgette soup interventions | Comparison of fasting plasma glucose between baseline and at 12 weeks and washout (24 weeks) and 36 weeks. | Week: 0 to12 and 24 to 36. |
| Change in fasting plasma insulin (mmol/L) after broccoli and courgette soup interventions | Comparison of fasting plasma insulin between baseline and at 12 weeks and washout (24 weeks) and 36 weeks. | Week: 0 to12 and 24 to 36. |
| Change in fasting serum fructosamine (µmol/L) after broccoli and courgette soup interventions | Comparison of fasting serum fructosamine between baseline and at 12 weeks as well as washout (24 weeks) and 36 weeks. | Week: 0 to12 and 24 to 36. |
| Change in fasting serum cholesterol (mmol/L) after broccoli and courgette soup interventions | Comparison of fasting serum cholesterol between baseline and at 12 weeks as well as washout (24 weeks) and 36 weeks. | Week: 0 to12 and 24 to 36. |
| Change in fasting serum triglycerides (mmol/L) after broccoli and courgette soup interventions | Comparison of fasting serum triglycerides between baseline and at 12 weeks as well as washout (24 weeks) and 36 weeks. | Week: 0 to12 and 24 to 36. |
| Change in broccoli metabolites (glucosinolates, sulforaphane, and S-methyl cysteine sulfoxide) in 24 hour urine collection | Quantification of broccoli metabolite excretion into urine metabolites will be measured from 24-hour urine collections using targeted metabolite analysis of glucosinolates, sulforaphane, and S-methyl cysteine sulfoxide. These metabolites will be used to define relationships between dietary intake, broccoli metabolism and the biological outcomes | Week: 0, 12, 24, and 36. |
| Treatment effects on whole blood gene expression from RNAseq | The effect of soup consumption will be tested using edgeR and Limma to fit linear models to gene expression data. False discovery rate will be corrected using the Benjamin Hochberg procedure | up to 36 weeks. |