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Effects of Polyphenols Found in Pomegranate and Olives Food Supplements on Postprandial Blood Glucose in Vivo.

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ClinicalTrials.gov Identifier: NCT02486978
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Hilda Nyambe, University of Leeds

Brief 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. 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.

POMEGRANATE AND OLIVE STUDIES WILL BE TREATED SEPARATELY FOR PURPOSES OF PUBLISHING RESULTS. EACH STUDY WILL AIM TO HAVE AT LEAST 16 PARTICIPANTS.


Condition or disease Intervention/treatment Phase
Hyperglycaemia Other: Control (109 g white bread) Dietary Supplement: Dose 1 Dietary Supplement: Dose 2 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Polyphenols Found in Pomegranate and Olives Food Supplements on Postprandial Blood Glucose in Vivo.
Study Start Date : June 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Control (no supplement)
Reference will be white bread to give 50 g available carbohydrates with placebo capsule
Other: Control (109 g white bread)
Control meal of 109 g white bread to which the response of the test meals with dietary supplements will be compared to.
Dietary Supplement: Dose 1
The test meal will contain a single dose of the supplements whose response will be compared to that of the control meal.
Dietary Supplement: Dose 2
The test meal will contain a double dose of the supplements whose response will be compared to that of the control meal.
Experimental: Dose 1
Test will comprise white bread to give 50 g available carbohydrates and one capsule of pomegranate/olive and one capsule placebo
Other: Control (109 g white bread)
Control meal of 109 g white bread to which the response of the test meals with dietary supplements will be compared to.
Dietary Supplement: Dose 1
The test meal will contain a single dose of the supplements whose response will be compared to that of the control meal.
Dietary Supplement: Dose 2
The test meal will contain a double dose of the supplements whose response will be compared to that of the control meal.
Experimental: Dose 2
Test will comprise white bread to give 50 g available carbohydrates and 2 capsules of pomegranate/olive.
Other: Control (109 g white bread)
Control meal of 109 g white bread to which the response of the test meals with dietary supplements will be compared to.
Dietary Supplement: Dose 1
The test meal will contain a single dose of the supplements whose response will be compared to that of the control meal.
Dietary Supplement: Dose 2
The test meal will contain a double dose of the supplements whose response will be compared to that of the control meal.



Primary Outcome Measures :
  1. Incremental area under the glucose curve [ Time Frame: 6 months ]


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)

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): NCT02486978


Locations
United Kingdom
School of Food Science and Nutrition
Leeds, West Yorkshire, 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hilda Nyambe, PhD student, University of Leeds
ClinicalTrials.gov Identifier: NCT02486978     History of Changes
Other Study ID Numbers: MEEC 14-029
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases