Broccoli Effect on Glycated Haemoglobin (HbA1c) (BETA)
Primary Purpose
Pre-diabetes
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Broccoli soup
Courgette soup
Sponsored by
About this trial
This is an interventional basic science trial for Pre-diabetes focused on measuring Broccoli, Pre-diabetes, Glycated Haemoglobin (HbA1c), Glucose, Energy metabolism
Eligibility Criteria
Inclusion Criteria:
- Individuals with prediabetes (confirmed through screening)
- Aged 18 and older.
- Body Mass Index (BMI) between 18.5 - 35 kg/m2.
- Living within 40 miles from the Norwich Research Park.
Exclusion Criteria:
The participant will not be able to take part if they('re):
- Screening test results indicate they are not suitable to take part in this study such as HbA1c level at screening visit of < 42 mmol/mol (healthy) and > 47 mmol/mol (diabetes) and BMI at screening visit < 18.5 kg/m2 (underweight) and > 35 kg/m2 (extremely obese).
- Have a known allergy to any of the components (broccoli, courgette, milk, lactose, or gluten) of the test soups.
- Have been diagnosed or have a history of blood or clotting disorders such as anaemia or thrombosis.
- Have been treated for heart disease, cancer, or diabetes.
- Are immunocompromised due to medications or viral infection such human immunodeficiency virus (HIV).
- Have low or high blood pressure with hypertension medication (≤90/60, ≥160/100 respectively would be classed as abnormal).
- Have any acute or chronic illnesses that affects the outcome of the study such as a gastrointestinal disorder. This will be assessed on a case by case basis by QI medical advisor.
- Plan to become pregnant during the study duration, pregnant or breastfeeding.
- Frequently take medications that may interfere with sugar metabolism or absorption such as laxatives, steroids, dietary supplements, or anti-inflammatory medications. This will be assessed on a case by case basis by QI medical advisor.
- Drink more than 14 alcohol units/week.
- Smoke socially or on occasion more than 12.5 grams or 20 cigarettes/week
- Vegan or any dietary restrictions that prevent the consumption of study soups or follow a diet programme which requires fasting for multiple days.
- Are a registered blood donor and have donated a large quantity of blood within the last 16 weeks. Registered blood donors should abstain from blood donations for the duration of the study.
- Are unable to give written or verbal informed consent
- Unable to provide GP contact details.
- Are participating in another dietary intervention study nor given blood in another dietary study in the last 3 months.
- Are related to or living with any member of the study team or part of the management/supervisory structure of the Chief Investigator.
- Have symptoms of COVID-19, been asked to self-isolate, or have been diagnosed with COVID-19 in the last 14 days.
Sites / Locations
- Quadram Institute Bioscience
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Broccoli soup
Courgette soup
Arm Description
The soup will be made with a commercially available dried vegetable soup supplemented with broccoli powder.
The soup will be made with a commercially available dried vegetable soup supplemented with courgette powder.
Outcomes
Primary Outcome Measures
Change in glycated haemoglobin (HbA1c) after broccoli and courgette soup interventions
Comparison of fasting blood for HbA1c at baseline and after soup interventions
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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
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
Full Information
NCT ID
NCT05367024
First Posted
October 4, 2021
Last Updated
May 4, 2022
Sponsor
Quadram Institute Bioscience
Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05367024
Brief Title
Broccoli Effect on Glycated Haemoglobin (HbA1c)
Acronym
BETA
Official Title
Broccoli Effect on Glycated Haemoglobin (HbA1c) - BETA Study, A Randomised Double-blinded Crossover Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quadram Institute Bioscience
Collaborators
Norfolk and Norwich University Hospitals NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Broccoli, Pre-diabetes, Glycated Haemoglobin (HbA1c), Glucose, Energy metabolism
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double blind masking
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Broccoli soup
Arm Type
Experimental
Arm Description
The soup will be made with a commercially available dried vegetable soup supplemented with broccoli powder.
Arm Title
Courgette soup
Arm Type
Sham Comparator
Arm Description
The soup will be made with a commercially available dried vegetable soup supplemented with courgette powder.
Intervention Type
Other
Intervention Name(s)
Broccoli soup
Intervention Description
Participants will consume one broccoli soup three times a week for one 12-week intervention period as part of their normal diet.
Intervention Type
Other
Intervention Name(s)
Courgette soup
Intervention Description
Participants will consume one courgette soup three times a week for one 12-week intervention period as part of their normal diet.
Primary Outcome Measure Information:
Title
Change in glycated haemoglobin (HbA1c) after broccoli and courgette soup interventions
Description
Comparison of fasting blood for HbA1c at baseline and after soup interventions
Time Frame
Week: 0, 12, 24 and 36.
Secondary Outcome Measure Information:
Title
Change in postprandial capillary glucose concentration
Description
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.
Time Frame
3.5 hours
Title
Change in fasting plasma glucose (mmol/l) after broccoli and courgette soup interventions
Description
Comparison of fasting plasma glucose between baseline and at 12 weeks and washout (24 weeks) and 36 weeks.
Time Frame
Week: 0 to12 and 24 to 36.
Title
Change in fasting plasma insulin (mmol/L) after broccoli and courgette soup interventions
Description
Comparison of fasting plasma insulin between baseline and at 12 weeks and washout (24 weeks) and 36 weeks.
Time Frame
Week: 0 to12 and 24 to 36.
Title
Change in fasting serum fructosamine (µmol/L) after broccoli and courgette soup interventions
Description
Comparison of fasting serum fructosamine between baseline and at 12 weeks as well as washout (24 weeks) and 36 weeks.
Time Frame
Week: 0 to12 and 24 to 36.
Title
Change in fasting serum cholesterol (mmol/L) after broccoli and courgette soup interventions
Description
Comparison of fasting serum cholesterol between baseline and at 12 weeks as well as washout (24 weeks) and 36 weeks.
Time Frame
Week: 0 to12 and 24 to 36.
Title
Change in fasting serum triglycerides (mmol/L) after broccoli and courgette soup interventions
Description
Comparison of fasting serum triglycerides between baseline and at 12 weeks as well as washout (24 weeks) and 36 weeks.
Time Frame
Week: 0 to12 and 24 to 36.
Title
Change in broccoli metabolites (glucosinolates, sulforaphane, and S-methyl cysteine sulfoxide) in 24 hour urine collection
Description
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
Time Frame
Week: 0, 12, 24, and 36.
Title
Treatment effects on whole blood gene expression from RNAseq
Description
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
Time Frame
up to 36 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals with prediabetes (confirmed through screening)
Aged 18 and older.
Body Mass Index (BMI) between 18.5 - 35 kg/m2.
Living within 40 miles from the Norwich Research Park.
Exclusion Criteria:
The participant will not be able to take part if they('re):
Screening test results indicate they are not suitable to take part in this study such as HbA1c level at screening visit of < 42 mmol/mol (healthy) and > 47 mmol/mol (diabetes) and BMI at screening visit < 18.5 kg/m2 (underweight) and > 35 kg/m2 (extremely obese).
Have a known allergy to any of the components (broccoli, courgette, milk, lactose, or gluten) of the test soups.
Have been diagnosed or have a history of blood or clotting disorders such as anaemia or thrombosis.
Have been treated for heart disease, cancer, or diabetes.
Are immunocompromised due to medications or viral infection such human immunodeficiency virus (HIV).
Have low or high blood pressure with hypertension medication (≤90/60, ≥160/100 respectively would be classed as abnormal).
Have any acute or chronic illnesses that affects the outcome of the study such as a gastrointestinal disorder. This will be assessed on a case by case basis by QI medical advisor.
Plan to become pregnant during the study duration, pregnant or breastfeeding.
Frequently take medications that may interfere with sugar metabolism or absorption such as laxatives, steroids, dietary supplements, or anti-inflammatory medications. This will be assessed on a case by case basis by QI medical advisor.
Drink more than 14 alcohol units/week.
Smoke socially or on occasion more than 12.5 grams or 20 cigarettes/week
Vegan or any dietary restrictions that prevent the consumption of study soups or follow a diet programme which requires fasting for multiple days.
Are a registered blood donor and have donated a large quantity of blood within the last 16 weeks. Registered blood donors should abstain from blood donations for the duration of the study.
Are unable to give written or verbal informed consent
Unable to provide GP contact details.
Are participating in another dietary intervention study nor given blood in another dietary study in the last 3 months.
Are related to or living with any member of the study team or part of the management/supervisory structure of the Chief Investigator.
Have symptoms of COVID-19, been asked to self-isolate, or have been diagnosed with COVID-19 in the last 14 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Kroon, PhD
Organizational Affiliation
Quadram Institute Bioscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quadram Institute Bioscience
City
Norwich
ZIP/Postal Code
NR4 7UQ
Country
United Kingdom
12. IPD Sharing Statement
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Broccoli Effect on Glycated Haemoglobin (HbA1c)
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