Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06385626
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-19
Brief Title:
The Effects of Raspberry Leaf Tea on Blood Glucose Control
Sponsor:
University of Reading
Organization:
University of Reading
Study Overview
Official Title:
The Effects of Raspberry Leaf Tea on Blood Glucose Control in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RLT
Brief Summary:
The aim of the present clinical trial is to assess how raspberry leaf polyphenols impact on postprandial glucose and insulin levels in healthy individuals consuming sucrose
The questions the project will address
Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans
Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose
20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication eg drugs from a GP for high blood pressure high blood fats inflammatory conditions and depression or dietary supplements eg cholesterol-lowering spreads fish oil probiotics prebiotics and natural laxatives antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism No abnormal results for liver function tests renal function tests and lipid profile tests If they have food allergies or consume more than 14 units of alcohol per week ie to help they calculate a alcohol intake one standard glass of wine 175 ml or one pint of regular lager is equivalent to just over two units of alcohol frequently travel for work or are participating in another intervention study they will not be able to participate Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part not use herbal medicines for at least the previous three months not be on a weight loss program six months before screening not involved in clinical trials six months before the screening and not having severe cardiac hepatic or renal function impairment Not Sufferers of chronic illnesses not Individuals with food allergies not people with coeliac disease
They will be asked to attend a four-study visit after an eight-hour overnight fast Volunteers will be asked to consume 50 g of carbohydrate powder sucrose and glucose with or without 10 g of raspberry leaf tea which will be dissolved in 300 mL of warm water during four visits every month Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control Blood glucose and insulin levels will be tested 15 minutes before at 15306090 and 120 minutes after carbohydrate intake
The questions the project will address
Do raspberry leaf polyphenols lower sucrose-induced increases in plasma glucose in humans
Do these polyphenols mediate these effects by inhibiting digestion of sucrose or the absorption of glucose
20 healthy adults will be recruited between the ages of 18-65 years who are non-smokers and not taking certain types of medication eg drugs from a GP for high blood pressure high blood fats inflammatory conditions and depression or dietary supplements eg cholesterol-lowering spreads fish oil probiotics prebiotics and natural laxatives antibiotics in the last three months or if they used any drugs or supplements that could affect their blood glucose or lipid metabolism No abnormal results for liver function tests renal function tests and lipid profile tests If they have food allergies or consume more than 14 units of alcohol per week ie to help they calculate a alcohol intake one standard glass of wine 175 ml or one pint of regular lager is equivalent to just over two units of alcohol frequently travel for work or are participating in another intervention study they will not be able to participate Women who are pregnant or lactating or planning a pregnancy in the next six months will also not be able to take part not use herbal medicines for at least the previous three months not be on a weight loss program six months before screening not involved in clinical trials six months before the screening and not having severe cardiac hepatic or renal function impairment Not Sufferers of chronic illnesses not Individuals with food allergies not people with coeliac disease
They will be asked to attend a four-study visit after an eight-hour overnight fast Volunteers will be asked to consume 50 g of carbohydrate powder sucrose and glucose with or without 10 g of raspberry leaf tea which will be dissolved in 300 mL of warm water during four visits every month Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control Blood glucose and insulin levels will be tested 15 minutes before at 15306090 and 120 minutes after carbohydrate intake
Detailed Description:
The volunteer inclusion criteria are Fasting blood glucose in the range 55 mmoll at day 0 A signed consent form Age 18-65 years Body mass index 349 kgm2 Non-smoking No pregnancylactation No use of herbal medicines for at least the previous three months Not on a weight loss program six months before screening Not involved in clinical trial six months before screening Not had severe cardiac hepatic or renal function impairment
The volunteer exclusion criteria are Smoking Pregnancylactation Use of herbal medicines for at least the previous three months Involved in a weight loss program six months before screening Involved in clinical trial six months before the screening Had severe cardiac hepatic or renal function impairment Sufferers of chronic illnesses Individuals with food allergies People with prediabetes or diabetes People with coeliac disease
If all subjects are generally healthy as demonstrated by their medical history and laboratory tests including fasting blood sugar and insulin levels as well as HOMA-IR liver function tests alanine transaminase alkaline phosphatase total bilirubin and gamma-GT renal function tests uric acid and creatinine and lipid profile tests total cholesterol Triglycerides They will be asked to attend a four-study visit after an eight-hour overnight fast Volunteers will be asked to consume 50 g of carbohydrate powder sucrose and glucose with or without 10 g of raspberry leaf tea which will be dissolved in 300 mL of warm water during four visits every month Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control Blood glucose and insulin levels will be tested 15 minutes before at 15306090 and 120 minutes after carbohydrate intake
The volunteer exclusion criteria are Smoking Pregnancylactation Use of herbal medicines for at least the previous three months Involved in a weight loss program six months before screening Involved in clinical trial six months before the screening Had severe cardiac hepatic or renal function impairment Sufferers of chronic illnesses Individuals with food allergies People with prediabetes or diabetes People with coeliac disease
If all subjects are generally healthy as demonstrated by their medical history and laboratory tests including fasting blood sugar and insulin levels as well as HOMA-IR liver function tests alanine transaminase alkaline phosphatase total bilirubin and gamma-GT renal function tests uric acid and creatinine and lipid profile tests total cholesterol Triglycerides They will be asked to attend a four-study visit after an eight-hour overnight fast Volunteers will be asked to consume 50 g of carbohydrate powder sucrose and glucose with or without 10 g of raspberry leaf tea which will be dissolved in 300 mL of warm water during four visits every month Blood samples will be taken at intervals for a period of two hours after the consumption of raspberry leaf or control Blood glucose and insulin levels will be tested 15 minutes before at 15306090 and 120 minutes after carbohydrate intake
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None