HyperglycemiaNCT03093753
Effect of a Beverage Comprised of Compounds From Olives on Post-prandial Blood Glucose Responses in Healthy Volunteers
A study testing Test (study 1) and Test (study 2) in people with Hyperglycemia, run by University of Leeds.
Trial summary
Consumption of carbohydrate containing foods or sugary drinks brings about changes to the blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak concentration usually after 30 minutes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Test (study 1) and Test (study 2)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Measured
- Fasting plasma glucose between 3.9 -5.6 mmol/L Self-assessed
- Apparently healthy
- Not diabetic
- Not pregnant nor lactating
- Not on special diet (for loosing weight)
- Not on long term prescribed medication
Who cannot join
- Measured
- Fasting plasma glucose >5.6 mmol/L
- Self-assessed
- Not healthy
- Diabetic
- Pregnant or lactating
Show all 11Show fewer
- On special diet (for loosing weight)
- On long term prescribed medication
- Smoker
- Diabetic
- Allergic to olives
About this study
Consumption of carbohydrate containing foods or sugary drinks brings about changes to the blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak concentration usually after 30 minutes. When the body senses the increase in blood glucose, a hormonal process involving insulin takes place to ensure that the glucose is taken up from the blood for storage and where it is needed for energy in the body. This process then brings about a decrease in the concentration of glucose until it reaches approximately the starting concentration. The original concentration of glucose is attained approximately 2 hours after eating or drinking a carbohydrate food or sugary drink respectively in healthy people.
Different carbohydrates and sugary drinks have different effects on blood glucose response depending on the amount as well as the type of carbohydrate. Those that give rise to a high glucose response compared to a reference carbohydrate (usually glucose) are said to be high glycaemic index (GI) foods and those with a lower glucose response compared to a reference carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.
Read more
Research has shown that diets that give rise to a high glucose response are associated with a number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly comprises of insulin resistance and glucose intolerance which gives an increased risk of type 2 diabetes. It also gives rise to other conditions like high blood pressure (arterial hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises. Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI) rather than rapidly (high GI) have health benefits which include reducing the risk of metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits, vegetables and plant based foods have a positive effect on carbohydrate metabolism and can lower the blood glucose levels.
This research will determine whether the presence of polyphenols in the diet has any lowering effect on the blood glucose levels and hence the glycaemic index of foods. This will be determined by asking volunteers to consume pomegranate polyphenols together with different carbohydrate sources which will define the 6 different interventions. The blood glucose response of bread will be determined initially as a control reference. All meals will be consumed in random order.
Analysis will be done by measuring blood glucose response after consumption of the control reference meal and the test meal containing polyphenols and then determining the incremental area under the glucose curve.
THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.
Read the detailed description
The world health organisation has reported that over 220 million people suffer from diabetes worldwide and that by the year 2030, this number will be doubled. The WHO also reports that in 2004, about 3.4 million people died from high blood sugar. About 90% of all diabetes cases is due to type II diabetes. Type 2 diabetes is largely due to overweight and lack of physical activity characterised by high glucose levels (hyperglycaemia).
In the human diet, the source of blood glucose is carbohydrates. Dietary carbohydrate is important to maintain glycaemic homeostasis and provides the most of the energy in the diets of most people. The control of blood glucose is a hormonal process and it is very important to human physiology. Hormonal processes involve the release of insulin from the β- cells of the pancreatic cells which stimulates the uptake of glucose after a meal, to other tissues either for utilisation (glycolysis) or to be stored in the liver as glycogen (glycogenesis). When blood glucose falls below normal, glucagon is secreted from the pancreatic α-cells and it promotes liver glucose production by inducing the generation of glucose from non-carbohydrate substrates such as amino and fatty acids (gluconeogenesis) and the generation of glucose from glycogen (glycogenolysis).
When the glucose homeostasis hormonal control fails, it entails high blood glucose levels (postprandial hyperglycaemia) which can lead to metabolic syndrome which includes obesity, impaired glucose tolerance (IGT), hypertension and dyslipidemia. Disturbance of glucose homeostasis can also lead to other symptoms such as inflammation and oxidative stress at the whole body level as well as disturbances of the functionality in several organs as well as diabetes. Therefore, as much as carbohydrates are required in the human body as a major source of energy, too much in the diet can have adverse health effects especially the one with high glycaemic effect.
The proposed mechanism adapted from Aston, 2006 of how carbohydrates may affect human health is that when there is a continual presence of high glycaemic index foods in the diet, this gives rise to postprandial glucose rise as well as high insulin demand to act on the high blood glucose levels in the blood. Postprandial glucose rise and high insulin demand may lead to insulin resistance which is the major component of metabolic syndrome. High insulin demand may also lead to β-cell failure which may also result in hyperglycaemia which is also a cause of insulin resistance. Insulin resistance and hyperglycaemia are risk factors for metabolic syndrome and diabetes type 2.
Scientific evidence suggest that postprandial hyperglycaemia in humans has a major role to play in health priorities like type 2 diabetes and blood glucose control. It has been reported that about 90% of all diabetes cases consist of type 2 diabetes. Apart from type I and type 2 diabetes, there are other related conditions which include pre-diabetes (impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) as well as metabolic syndrome (obesity, hypertension and insulin resistance). It has been reported that pre-diabetes and metabolic syndrome increases the risk of developing cardiovascular disease and diabetes mellitus. The glycaemic index was originally proposed with the aim of managing diabetes. However, recent studies have shown that the GI has potential in the prevention of type 2 diabetes as well as in the treatment of metabolic syndrome. Research has shown that high GI diets are associated with increased risk of developing type 2 diabetes. More research has shown that high GI diet is associated with a number of abnormalities like increased metabolic syndrome and insulin resistance. In the same way, a low GI diet is said to improve insulin sensitivity but more research is needed to support this. A few studies have shown this to be the case. However it was observed that it was difficult to know whether this was as a result of improved insulin sensitivity, or improved insulin secretion or due to reduced rate of glucose absorption.
Potential solution having anything in the diet that can either slow down the digestion and absorption of carbohydrates can help reduce the risk. Among others, two potential solutions are that of consumption of low glycaemic index foods or having ingredients in the diet that can reduce the glycaemic index of foods as well as postprandial blood glucose levels. The presence of inhibiting components in the diet that can reduce postprandial glucose can also be a solution to reducing the risk. Drugs like acarbose are currently used in some countries for the management of type 2 diabetes which act by inhibiting carbohydrate digestive enzymes. However, the use of acarbose has side effects such as nausea, flatulence and diarrhoea. It has been reported that polyphenols also have the potential to inhibit the rise in blood glucose by hindering the rapid absorption of glucose.
A recent review has reported that research using animal models as well as a limited number of human studies, have shown that polyphenols and polyphenol rich foods or beverages have the potential to affect postprandial glycaemic responses and fasting glycaemia as well as an improvement of acute insulin secretion and sensitivity. Other possible mechanisms as reported in the review include pancreatic β- cells stimulation to secrete insulin as well as activation of insulin receptors, modulation of the release of glucose from the liver as well as of intracellular signalling pathways and gene expression.
Another recent review concluded that it is very possible that the effects of polyphenols in the diet will affect glycaemic index of foods as well as postprandial glucose responses in humans. The two mechanisms highlighted by which this can be achieved being the inhibition of sugar metabolising enzymes as well as transporters. This potential action of polyphenols can thus be compared to that of acarbose which acts by the same mechanism and research in chronic intervention studies has shown that it reduces diabetes risk.
This research will involve the use of soluble olive powder as a source of polyphenols to determine its effects on the glycaemic response when consumed together with a carbohydrate source. Four interventions will be carried out as follows:
- White bread as source of carbohydrate
- Whole meal bread as source of carbohydrate
- Glucose as source of carbohydrate
- Sucrose as source of carbohydrate
- White bread as source of carbohydrate but with 3 days high fat diet prior to the study visit.
- White bread as source of carbohydrate but with 3 days high carbohydrate diet prior to the study visit.
The study was approved by the University of Leeds Mathematical and Physical Sciences (MAPs) ethical committee with application number MEEC15-044. At least 10 volunteers will be recruited for each intervention (white bread, whole bread, glucose, sucrose, 3 days high fat diet, 3 days high carbohydrate diet). The volunteers will be screened for their fasting blood glucose level. They will need to be healthy and their fasting blood glucose levels should fall within the healthy range of 4.3-5.9mmol/L.
The volunteers are scheduled to attend 3 visits. During each visit, the volunteer comes fasted in the morning and the fasting blood glucose is measured by the use of a glucometer. The volunteer is then given a test meal which will be randomized and blood glucose will be measured at 15, 30, 45, 60, 90, 120,150 and 180 minutes after the first bite of the test meal. The results will be used to plot the area under the curve and results obtained after consuming test meals will be compared to those obtained after consumption of control meals.
THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.
- Conditions
- Hyperglycemia
- Being tested
- Control (study 1), Test (study 1), Control (study 2), Test (study 2), Control (study 3)
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (study 1)Other
Control meal will comprise of 50 g glucose dissolved in 200 ml water, to which the response of the test meals will be compared to
Test (study 1)Other
The test meal will comprise 50 g glucose in 200 ml water plus 50 mg oleuropein from olives
Control (study 2)Other
Control meal will comprise 109 g white bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to
Test (study 2)Dietary supplement
The test meal will comprise 109 g white bread plus 50 mg oleuropein from olives dissolved in 200 ml water
Control (study 3)Other
Control meal will comprise whole-meal bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to
Test (study 3)Dietary supplement
The test meal will comprise whole-meal bread plus 50 mg oleuropein from olives dissolved in 200 ml water
Control (study 4)Other
Control meal will comprise 50 g sucrose in 200 ml water, to which the response of the test meals will be compared to
Test (study 4)Dietary supplement
The test meal will comprise 50 g sucrose in 200 ml water plus 50 mg oleuropein from olives
Control (study 5)Other
Control meal will comprise 25 g sucrose in 200 ml water, to which the response of the test meals will be compared to
Test (study 5)Other
The test meal will comprise 25 g sucrose in 200 ml water plus 160 mg oleuropein from olives
Control (study 6)Other
Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
Test (study 6)Other
High carbohydrate diet (23% fat, 55% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
Control (study 7)Other
Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
Test (study 7)Other
High fat diet (44% fat, 34% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
| Study group | Role | What they receive |
|---|---|---|
| Control (study 1) | Placebo comparator | Control will be 50g glucose dissolved in 200 mL water Receives: Other: Control (study 1) |
| Test (study 1) | Experimental | The test meals will comprise 50 g glucose plus 50 mg oleuropein from olives dissolved in 200 mL water Receives: Other: Test (study 1) |
| Control (study 2) | Placebo comparator | Control will be white bread (109 g) to give 50 g available carbohydrates with 200 mL water Receives: Other: Control (study 2) |
| Test (study 2) | Experimental | The test meals will comprise 109 g white bread plus 50 mg oleuropein from olives Receives: Dietary Supplement: Test (study 2) |
| Control (study 3) | Placebo comparator | Control will be whole-meal bread (132 g) to give 50 g available carbohydrates with 200 mL water Receives: Other: Control (study 3) |
| Test (study 3) | Experimental | The test meals will comprise whole-meal bread (132 g) with 50 mg oleuropein dissolved in 200 mL water Receives: Dietary Supplement: Test (study 3) |
| Control (study 4) | Placebo comparator | Control will be 50 g sucrose dissolved in 200 mL water Receives: Other: Control (study 4) |
| Test (study 4) | Experimental | The test meals will comprise 50 mg oleuropein and 50 g sucrose dissolved in 200 ml water Receives: Dietary Supplement: Test (study 4) |
| Control (study 5) | Placebo comparator | Control will be 25 g sucrose dissolved in 200 mL water Receives: Other: Control (study 5) |
| Test (study 5) | Experimental | The test meals will comprise 160 mg oleuropein and 25 g sucrose dissolved in 200 ml water Receives: Other: Test (study 5) |
| Control (study 6) | Placebo comparator | Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit Receives: Other: Control (study 6) |
| Test (study 6) | Experimental | High carbohydrate diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit Receives: Other: Test (study 6) |
| Control (study 7) | Placebo comparator | Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit Receives: Other: Control (study 7) |
| Test (study 7) | Experimental | High fat diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit Receives: Other: Test (study 7) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the glucose curve
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startJul 2016
- Primary completionAug 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Williamson, University of Leeds
- Investigators
- Gary Williamson, Study chair, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093753
- Sponsor's protocol ID
- MEEC 15-044
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Beverage Comprised of Compounds From Olives on Post-prandial Blood Glucose Responses in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03093753
- Acronym / sponsor ID
- MEEC 15-044
- Conditions
- Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Consumption of carbohydrate containing foods or sugary drinks brings about changes to the blood glucose levels. After a meal or drink, blood glucose rises until it reaches a peak concentration usually after 30 minutes. When the body senses the increase in blood glucose, a hormonal process involving insulin takes place to ensure that the glucose is taken up from the blood for storage and where it is needed for energy in the body. This process then brings about a decrease in the concentration of glucose until it reaches approximately the starting concentration. The original concentration of glucose is attained approximately 2 hours after eating or drinking a carbohydrate food or sugary drink respectively in healthy people.
Different carbohydrates and sugary drinks have different effects on blood glucose response depending on the amount as well as the type of carbohydrate. Those that give rise to a high glucose response compared to a reference carbohydrate (usually glucose) are said to be high glycaemic index (GI) foods and those with a lower glucose response compared to a reference carbohydrate (usually glucose) are said to be low glycaemic index (GI) foods.
Research has shown that diets that give rise to a high glucose response are associated with a number of abnormalities like increased risk of metabolic syndrome. Metabolic syndrome mostly comprises of insulin resistance and glucose intolerance which gives an increased risk of type 2 diabetes. It also gives rise to other conditions like high blood pressure (arterial hypertension), elevated blood insulin levels (hyper-insulinemia), elevated amounts of fat in the liver (fatty hepatosis) and elevated amounts of lipids in the blood (dyslipidemia). After type 2 diabetes become clinically apparent, the risk of cardiovascular disease also rises. Research has also shown that foods/drinks which raise blood glucose levels gradually (low GI) rather than rapidly (high GI) have health benefits which include reducing the risk of metabolic syndrome. Laboratory studies have shown that polyphenols found in fruits, vegetables and plant based foods have a positive effect on carbohydrate metabolism and can lower the blood glucose levels.
This research will determine whether the presence of polyphenols in the diet has any lowering effect on the blood glucose levels and hence the glycaemic index of foods. This will be determined by asking volunteers to consume pomegranate polyphenols together with different carbohydrate sources which will define the 6 different interventions. The blood glucose response of bread will be determined initially as a control reference. All meals will be consumed in random order.
Analysis will be done by measuring blood glucose response after consumption of the control reference meal and the test meal containing polyphenols and then determining the incremental area under the glucose curve.
THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.
Detailed description
The world health organisation has reported that over 220 million people suffer from diabetes worldwide and that by the year 2030, this number will be doubled. The WHO also reports that in 2004, about 3.4 million people died from high blood sugar. About 90% of all diabetes cases is due to type II diabetes. Type 2 diabetes is largely due to overweight and lack of physical activity characterised by high glucose levels (hyperglycaemia).
In the human diet, the source of blood glucose is carbohydrates. Dietary carbohydrate is important to maintain glycaemic homeostasis and provides the most of the energy in the diets of most people. The control of blood glucose is a hormonal process and it is very important to human physiology. Hormonal processes involve the release of insulin from the β- cells of the pancreatic cells which stimulates the uptake of glucose after a meal, to other tissues either for utilisation (glycolysis) or to be stored in the liver as glycogen (glycogenesis). When blood glucose falls below normal, glucagon is secreted from the pancreatic α-cells and it promotes liver glucose production by inducing the generation of glucose from non-carbohydrate substrates such as amino and fatty acids (gluconeogenesis) and the generation of glucose from glycogen (glycogenolysis).
When the glucose homeostasis hormonal control fails, it entails high blood glucose levels (postprandial hyperglycaemia) which can lead to metabolic syndrome which includes obesity, impaired glucose tolerance (IGT), hypertension and dyslipidemia. Disturbance of glucose homeostasis can also lead to other symptoms such as inflammation and oxidative stress at the whole body level as well as disturbances of the functionality in several organs as well as diabetes. Therefore, as much as carbohydrates are required in the human body as a major source of energy, too much in the diet can have adverse health effects especially the one with high glycaemic effect.
The proposed mechanism adapted from Aston, 2006 of how carbohydrates may affect human health is that when there is a continual presence of high glycaemic index foods in the diet, this gives rise to postprandial glucose rise as well as high insulin demand to act on the high blood glucose levels in the blood. Postprandial glucose rise and high insulin demand may lead to insulin resistance which is the major component of metabolic syndrome. High insulin demand may also lead to β-cell failure which may also result in hyperglycaemia which is also a cause of insulin resistance. Insulin resistance and hyperglycaemia are risk factors for metabolic syndrome and diabetes type 2.
Scientific evidence suggest that postprandial hyperglycaemia in humans has a major role to play in health priorities like type 2 diabetes and blood glucose control. It has been reported that about 90% of all diabetes cases consist of type 2 diabetes. Apart from type I and type 2 diabetes, there are other related conditions which include pre-diabetes (impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) as well as metabolic syndrome (obesity, hypertension and insulin resistance). It has been reported that pre-diabetes and metabolic syndrome increases the risk of developing cardiovascular disease and diabetes mellitus. The glycaemic index was originally proposed with the aim of managing diabetes. However, recent studies have shown that the GI has potential in the prevention of type 2 diabetes as well as in the treatment of metabolic syndrome. Research has shown that high GI diets are associated with increased risk of developing type 2 diabetes. More research has shown that high GI diet is associated with a number of abnormalities like increased metabolic syndrome and insulin resistance. In the same way, a low GI diet is said to improve insulin sensitivity but more research is needed to support this. A few studies have shown this to be the case. However it was observed that it was difficult to know whether this was as a result of improved insulin sensitivity, or improved insulin secretion or due to reduced rate of glucose absorption.
Potential solution having anything in the diet that can either slow down the digestion and absorption of carbohydrates can help reduce the risk. Among others, two potential solutions are that of consumption of low glycaemic index foods or having ingredients in the diet that can reduce the glycaemic index of foods as well as postprandial blood glucose levels. The presence of inhibiting components in the diet that can reduce postprandial glucose can also be a solution to reducing the risk. Drugs like acarbose are currently used in some countries for the management of type 2 diabetes which act by inhibiting carbohydrate digestive enzymes. However, the use of acarbose has side effects such as nausea, flatulence and diarrhoea. It has been reported that polyphenols also have the potential to inhibit the rise in blood glucose by hindering the rapid absorption of glucose.
A recent review has reported that research using animal models as well as a limited number of human studies, have shown that polyphenols and polyphenol rich foods or beverages have the potential to affect postprandial glycaemic responses and fasting glycaemia as well as an improvement of acute insulin secretion and sensitivity. Other possible mechanisms as reported in the review include pancreatic β- cells stimulation to secrete insulin as well as activation of insulin receptors, modulation of the release of glucose from the liver as well as of intracellular signalling pathways and gene expression.
Another recent review concluded that it is very possible that the effects of polyphenols in the diet will affect glycaemic index of foods as well as postprandial glucose responses in humans. The two mechanisms highlighted by which this can be achieved being the inhibition of sugar metabolising enzymes as well as transporters. This potential action of polyphenols can thus be compared to that of acarbose which acts by the same mechanism and research in chronic intervention studies has shown that it reduces diabetes risk.
This research will involve the use of soluble olive powder as a source of polyphenols to determine its effects on the glycaemic response when consumed together with a carbohydrate source. Four interventions will be carried out as follows:
- White bread as source of carbohydrate
- Whole meal bread as source of carbohydrate
- Glucose as source of carbohydrate
- Sucrose as source of carbohydrate
- White bread as source of carbohydrate but with 3 days high fat diet prior to the study visit.
- White bread as source of carbohydrate but with 3 days high carbohydrate diet prior to the study visit.
The study was approved by the University of Leeds Mathematical and Physical Sciences (MAPs) ethical committee with application number MEEC15-044. At least 10 volunteers will be recruited for each intervention (white bread, whole bread, glucose, sucrose, 3 days high fat diet, 3 days high carbohydrate diet). The volunteers will be screened for their fasting blood glucose level. They will need to be healthy and their fasting blood glucose levels should fall within the healthy range of 4.3-5.9mmol/L.
The volunteers are scheduled to attend 3 visits. During each visit, the volunteer comes fasted in the morning and the fasting blood glucose is measured by the use of a glucometer. The volunteer is then given a test meal which will be randomized and blood glucose will be measured at 15, 30, 45, 60, 90, 120,150 and 180 minutes after the first bite of the test meal. The results will be used to plot the area under the curve and results obtained after consuming test meals will be compared to those obtained after consumption of control meals.
THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Control (study 1) | Placebo comparator | Other: Control (study 1)Control will be 50g glucose dissolved in 200 mL water |
| Test (study 1) | Experimental | Other: Test (study 1)The test meals will comprise 50 g glucose plus 50 mg oleuropein from olives dissolved in 200 mL water |
| Control (study 2) | Placebo comparator | Other: Control (study 2)Control will be white bread (109 g) to give 50 g available carbohydrates with 200 mL water |
| Test (study 2) | Experimental | Dietary Supplement: Test (study 2)The test meals will comprise 109 g white bread plus 50 mg oleuropein from olives |
| Control (study 3) | Placebo comparator | Other: Control (study 3)Control will be whole-meal bread (132 g) to give 50 g available carbohydrates with 200 mL water |
| Test (study 3) | Experimental | Dietary Supplement: Test (study 3)The test meals will comprise whole-meal bread (132 g) with 50 mg oleuropein dissolved in 200 mL water |
| Control (study 4) | Placebo comparator | Other: Control (study 4)Control will be 50 g sucrose dissolved in 200 mL water |
| Test (study 4) | Experimental | Dietary Supplement: Test (study 4)The test meals will comprise 50 mg oleuropein and 50 g sucrose dissolved in 200 ml water |
| Control (study 5) | Placebo comparator | Other: Control (study 5)Control will be 25 g sucrose dissolved in 200 mL water |
| Test (study 5) | Experimental | Other: Test (study 5)The test meals will comprise 160 mg oleuropein and 25 g sucrose dissolved in 200 ml water |
| Control (study 6) | Placebo comparator | Other: Control (study 6)Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit |
| Test (study 6) | Experimental | Other: Test (study 6)High carbohydrate diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit |
| Control (study 7) | Placebo comparator | Other: Control (study 7)Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit |
| Test (study 7) | Experimental | Other: Test (study 7)High fat diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Measured
- Fasting plasma glucose between 3.9 -5.6 mmol/L Self-assessed
- Apparently healthy
- Not diabetic
- Not pregnant nor lactating
Key exclusion criteria (11 listed)
- Measured
- Fasting plasma glucose >5.6 mmol/L
- Self-assessed
- Not healthy
- Diabetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (study 1)Control meal will comprise of 50 g glucose dissolved in 200 ml water, to which the response of the test meals will be compared to | Other | Control (study 1) |
| Test (study 1)The test meal will comprise 50 g glucose in 200 ml water plus 50 mg oleuropein from olives | Other | Test (study 1) |
| Control (study 2)Control meal will comprise 109 g white bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to | Other | Control (study 2) |
| Test (study 2)The test meal will comprise 109 g white bread plus 50 mg oleuropein from olives dissolved in 200 ml water | Dietary supplement | Test (study 2) |
| Control (study 3)Control meal will comprise whole-meal bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to | Other | Control (study 3) |
| Test (study 3)The test meal will comprise whole-meal bread plus 50 mg oleuropein from olives dissolved in 200 ml water | Dietary supplement | Test (study 3) |
| Control (study 4)Control meal will comprise 50 g sucrose in 200 ml water, to which the response of the test meals will be compared to | Other | Control (study 4) |
| Test (study 4)The test meal will comprise 50 g sucrose in 200 ml water plus 50 mg oleuropein from olives | Dietary supplement | Test (study 4) |
| Control (study 5)Control meal will comprise 25 g sucrose in 200 ml water, to which the response of the test meals will be compared to | Other | Control (study 5) |
| Test (study 5)The test meal will comprise 25 g sucrose in 200 ml water plus 160 mg oleuropein from olives | Other | Test (study 5) |
| Control (study 6)Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day | Other | Control (study 6) |
| Test (study 6)High carbohydrate diet (23% fat, 55% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day | Other | Test (study 6) |
| Control (study 7)Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day | Other | Control (study 7) |
| Test (study 7)High fat diet (44% fat, 34% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day | Other | Test (study 7) |
Primary outcome
Incremental area under the glucose curve
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Williamson study chair
University of Leeds
Questions about this trial
What is this clinical trial studying?
A study testing Test (study 1) and Test (study 2) in people with Hyperglycemia, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental area under the glucose curve (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.