Type II DiabetesRLTNCT06385626
The Effects of Raspberry Leaf Tea on Blood Glucose Control
A study testing Raspberry leaf tea in people with Type II Diabetes, run by University of Reading at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes
- What is being tested?
- Raspberry leaf tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Dec 2023to 23 Dec 2024
- 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
The volunteer inclusion criteria are:
- Fasting blood glucose in the range < 5.5 mmol/l (at day 0)
- A signed consent forms.
- Age 18-65 years
- Body mass index ≤ 34.9 kg/m2
- Non-smoking
- No pregnancy/lactation
- 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
- Pregnancy/lactation
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hugh Sinclair Unit of Human Nutrition, University of Reading
Reading, Berkshire, RG6 5SG
About this study
Official title: The Effects of Raspberry Leaf Tea on Blood Glucose Control in Healthy Adults
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:
Read more
- 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 (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., 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 (i.e., 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 15,30,60,90, and 120 minutes after carbohydrate intake.
Read the detailed description
The volunteer inclusion criteria are: (Fasting blood glucose in the range < 5.5 mmol/l (at day 0); A signed consent form; Age 18-65 years; Body mass index ≤ 34.9 kg/m2; Non-smoking; No pregnancy/lactation; 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, Pregnancy/lactation; 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 15,30,60,90, and 120 minutes after carbohydrate intake.
- Conditions
- Type II Diabetes
- Being tested
- Raspberry leaf tea
- Keywords
- glucose, polyphenols
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raspberry leaf teaDietary supplement
10 g of raspberry leaf tea
| Study group | Role | What they receive |
|---|---|---|
| sucrose + raspberry leaf tea | Experimental | Volunteers will be asked to consume 50 g of sucrose with 10 g of raspberry leaf tea dissolved in 300 mL of warm water. Receives: Dietary Supplement: Raspberry leaf tea |
| glucose + raspberry leaf tea | Experimental | Volunteers will be asked to consume 50 g of glucose with10 g of raspberry leaf tea dissolved in 300 mL of warm water. Receives: Dietary Supplement: Raspberry leaf tea |
| sucrose | Active comparator | Volunteers will be asked to consume 50 g of sucrose without 10 g of raspberry leaf tea Receives: Dietary Supplement: Raspberry leaf tea |
| glucose | Active comparator | Volunteers will be asked to consume 50 g of glucose without 10 g of raspberry leaf tea Receives: Dietary Supplement: Raspberry leaf tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Area under the plasma glucose curve 0-120 minutes
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start18 Dec 2023
- Primary completion23 Dec 2024 (estimated)
- Study completion23 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy Spencer, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385626
- Sponsor's protocol ID
- UREC: 23_15-Raspberry Leaf Tea
- Acronym
- RLT
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Raspberry Leaf Tea on Blood Glucose Control in Healthy Adults
- ClinicalTrials.gov ID
- NCT06385626
- Acronym / sponsor ID
- RLT / UREC: 23_15-Raspberry Leaf Tea
- Conditions
- Type II Diabetes
- Keywords
- glucose, polyphenols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 23 Dec 2024 (estimated)
- Study completion
- 23 Dec 2024 (estimated)
- First posted
- 26 Apr 2024 (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.
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 (e.g., drugs from a GP for high blood pressure, high blood fats, inflammatory conditions, and depression) or dietary supplements (e.g., 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 (i.e., 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 15,30,60,90, and 120 minutes after carbohydrate intake.
Detailed description
The volunteer inclusion criteria are: (Fasting blood glucose in the range < 5.5 mmol/l (at day 0); A signed consent form; Age 18-65 years; Body mass index ≤ 34.9 kg/m2; Non-smoking; No pregnancy/lactation; 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, Pregnancy/lactation; 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 15,30,60,90, and 120 minutes after carbohydrate intake.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| sucrose + raspberry leaf tea | Experimental | Dietary Supplement: Raspberry leaf teaVolunteers will be asked to consume 50 g of sucrose with 10 g of raspberry leaf tea dissolved in 300 mL of warm water. |
| glucose + raspberry leaf tea | Experimental | Dietary Supplement: Raspberry leaf teaVolunteers will be asked to consume 50 g of glucose with10 g of raspberry leaf tea dissolved in 300 mL of warm water. |
| sucrose | Active comparator | Dietary Supplement: Raspberry leaf teaVolunteers will be asked to consume 50 g of sucrose without 10 g of raspberry leaf tea |
| glucose | Active comparator | Dietary Supplement: Raspberry leaf teaVolunteers will be asked to consume 50 g of glucose without 10 g of raspberry leaf tea |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Raspberry leaf tea10 g of raspberry leaf tea | Dietary supplement | glucose, glucose + raspberry leaf tea, sucrose, sucrose + raspberry leaf tea |
Primary outcome
Blood Glucose
Time frame: Two hours
Area under the plasma glucose curve 0-120 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- 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.
Jeremy Spencer, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raspberry leaf tea in people with Type II Diabetes, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Spencer, PhD (01183788724, j.p.e.spencer@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: Two hours). 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 26 Apr 2024.