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Effects of Polyphenols Found in Pomegranate Juice on Postprandial Blood Glucose in Vivo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02624609
First Posted: December 8, 2015
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hilda Nyambe, University of Leeds
  Purpose

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 commercially available food supplements together with white bread and then determining the glycaemic response. The blood glucose response of bread will be determined initially as a control reference. All 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.


Condition Intervention
Hyperglycaemia Other: Control without pomegranate juice Other: Test with pomegranate juice

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Polyphenols Found in Pomegranate Juice on Postprandial Blood Glucose in Vivo

Resource links provided by NLM:


Further study details as provided by Hilda Nyambe, University of Leeds:

Primary Outcome Measures:
  • Incremental area under the glucose curve [ Time Frame: 6 months ]
    The incremental area under the glucose curves for control and test meals will be compared.


Enrollment: 16
Study Start Date: November 2015
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control without pomegranate juice
Control meal will be white bread and a glass of water containing the same amounts of sugars naturally present in the pomegranate juice.
Other: Control without pomegranate juice
Control meal of 109 g white bread and 200 ml water (containing the same amount and type of sugars naturally present in pomegranate juice) to which the response of the test meal with pomegranate juice will be compared to.
Experimental: Test with pomegranate juice
Test meal will be white bread with a glass of pomegranate juice
Other: Test with pomegranate juice
The test meal will contain 109 g white bread and 200 ml of pomegranate juice whose response will be compared to that of the control meal.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Measured •Fasting glucose (blood glucose level before breakfast) 3.9 -5.9mmol/L

Self-assessed

  • Apparently healthy
  • Not diabetic
  • Not on long term prescribed medication (except contraceptives)
  • Not pregnant or lactating
  • Not on special diet (for losing weight or fruit extracts supplements)

Exclusion Criteria:

Measured

•Fasting glucose (blood glucose level before breakfast) >5.9mmol/L

Self-assessed

  • Not healthy
  • Diabetic
  • On long term prescribed medication (except contraceptives)
  • Pregnant or lactating
  • On special diet (for losing weight or fruit extracts supplements)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624609


Locations
United Kingdom
School of Food Science and Nutrition
Leeds, United Kingdom, LS2 9JT
Sponsors and Collaborators
University of Leeds
Investigators
Study Chair: Gary Williamson Professor and Chair of Functional foods
Principal Investigator: Hilda Nyambe Postgraduate research student
  More Information

Responsible Party: Hilda Nyambe, PhD student, University of Leeds
ClinicalTrials.gov Identifier: NCT02624609     History of Changes
Other Study ID Numbers: MEEC 12-037c
First Submitted: December 4, 2015
First Posted: December 8, 2015
Last Update Posted: June 5, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases