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Trial record 5 of 7 for:    oleuropein

Effect of a Beverage Comprised of Compounds From Olives on Post-prandial Blood Glucose Responses in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03093753
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Gary Williamson, 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 pomegranate polyphenols together with different carbohydrate sources which will define the 6 different interventions. The blood glucose response of bread will be determined initially as a control reference. All meals 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.

THE SIX DIFFERENT INTERVENTIONS MAY OR MAY NOT BE COMBINED FOR PURPOSES OF PUBLISHING RESULTS. EACH INTERVENTION WILL AIM TO HAVE AT LEAST 10 PARTICIPANTS.


Condition or disease Intervention/treatment Phase
Hyperglycemia Other: Control (study 1) Other: Test (study 1) Other: Control (study 2) Dietary Supplement: Test (study 2) Other: Control (study 3) Dietary Supplement: Test (study 3) Other: Control (study 4) Dietary Supplement: Test (study 4) Other: Control (study 5) Other: Test (study 5) Other: Control (study 6) Other: Test (study 6) Other: Control (study 7) Other: Test (study 7) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a Beverage Comprised of Compounds From Olives on Post-prandial Blood Glucose Responses in Healthy Volunteers
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control (study 1)
Control will be 50g glucose dissolved in 200 mL water
Other: Control (study 1)
Control meal will comprise of 50 g glucose dissolved in 200 ml water, to which the response of the test meals will be compared to

Experimental: Test (study 1)
The test meals will comprise 50 g glucose plus 50 mg oleuropein from olives dissolved in 200 mL water
Other: Test (study 1)
The test meal will comprise 50 g glucose in 200 ml water plus 50 mg oleuropein from olives

Placebo Comparator: Control (study 2)
Control will be white bread (109 g) to give 50 g available carbohydrates with 200 mL water
Other: Control (study 2)
Control meal will comprise 109 g white bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to

Experimental: Test (study 2)
The test meals will comprise 109 g white bread plus 50 mg oleuropein from olives
Dietary Supplement: Test (study 2)
The test meal will comprise 109 g white bread plus 50 mg oleuropein from olives dissolved in 200 ml water

Placebo Comparator: Control (study 3)
Control will be whole-meal bread (132 g) to give 50 g available carbohydrates with 200 mL water
Other: Control (study 3)
Control meal will comprise whole-meal bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to

Experimental: Test (study 3)
The test meals will comprise whole-meal bread (132 g) with 50 mg oleuropein dissolved in 200 mL water
Dietary Supplement: Test (study 3)
The test meal will comprise whole-meal bread plus 50 mg oleuropein from olives dissolved in 200 ml water

Placebo Comparator: Control (study 4)
Control will be 50 g sucrose dissolved in 200 mL water
Other: Control (study 4)
Control meal will comprise 50 g sucrose in 200 ml water, to which the response of the test meals will be compared to

Experimental: Test (study 4)
The test meals will comprise 50 mg oleuropein and 50 g sucrose dissolved in 200 ml water
Dietary Supplement: Test (study 4)
The test meal will comprise 50 g sucrose in 200 ml water plus 50 mg oleuropein from olives

Placebo Comparator: Control (study 5)
Control will be 25 g sucrose dissolved in 200 mL water
Other: Control (study 5)
Control meal will comprise 25 g sucrose in 200 ml water, to which the response of the test meals will be compared to

Experimental: Test (study 5)
The test meals will comprise 160 mg oleuropein and 25 g sucrose dissolved in 200 ml water
Other: Test (study 5)
The test meal will comprise 25 g sucrose in 200 ml water plus 160 mg oleuropein from olives

Placebo Comparator: Control (study 6)
Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit
Other: Control (study 6)
Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day

Experimental: Test (study 6)
High carbohydrate diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit
Other: Test (study 6)
High carbohydrate diet (23% fat, 55% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day

Placebo Comparator: Control (study 7)
Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit
Other: Control (study 7)
Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day

Experimental: Test (study 7)
High fat diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit
Other: Test (study 7)
High fat diet (44% fat, 34% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day




Primary Outcome Measures :
  1. Incremental area under the glucose curve [ Time Frame: 9 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Measured

  • Fasting plasma glucose between 3.9 -5.6 mmol/L Self-assessed
  • Apparently healthy
  • Not diabetic
  • Not pregnant nor lactating
  • Not on special diet (for loosing weight)
  • Not on long term prescribed medication

Exclusion Criteria:

Measured

  • Fasting plasma glucose >5.6 mmol/L

Self-assessed

  • Not healthy
  • Diabetic
  • Pregnant or lactating
  • On special diet (for loosing weight)
  • On long term prescribed medication
  • Smoker
  • Diabetic
  • Allergic to olives

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): NCT03093753


Sponsors and Collaborators
University of Leeds
Investigators
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Study Chair: Gary Williamson University of Leeds

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Responsible Party: Gary Williamson, Professor Gary Williamson, University of Leeds
ClinicalTrials.gov Identifier: NCT03093753     History of Changes
Other Study ID Numbers: MEEC 15-044
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Oleuropein
Anti-Infective Agents
Antihypertensive Agents
Vasodilator Agents