The Effects of Raspberry Leaf Tea on Blood Glucose Control

NCT06385626 | Recruiting

• 1 other identifier: UREC: 23_15-Raspberry Leaf Tea
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Type II Diabetes

Keywords

glucose; polyphenols

Outcome Measures

Primary Outcomes (1)

• Blood Glucose

  Area under the plasma glucose curve 0-120 minutes

  Two hours

Study Arms (4)

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.

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.

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

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

Dietary Supplement: Raspberry leaf tea

Interventions

Raspberry leaf tea DIETARY_SUPPLEMENT

10 g of raspberry leaf tea

glucose; glucose + raspberry leaf tea; sucrose; sucrose + raspberry leaf tea

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Sites (1)

Hugh Sinclair Unit of Human Nutrition, University of Reading

Reading, Berkshire, RG6 5SG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jeremy Spencer, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeremy Spencer, PhD

CONTACT

01183788724; j.p.e.spencer@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: 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).

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 26, 2024
• Study Start: December 18, 2023
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)