NCT03093753

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

March 22, 2017

Last Update Submit

April 17, 2018

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Incremental area under the glucose curve

    9 months

Study Arms (14)

Control (study 1)

PLACEBO COMPARATOR

Control will be 50g glucose dissolved in 200 mL water

Other: Control (study 1)

Test (study 1)

EXPERIMENTAL

The test meals will comprise 50 g glucose plus 50 mg oleuropein from olives dissolved in 200 mL water

Other: Test (study 1)

Control (study 2)

PLACEBO COMPARATOR

Control will be white bread (109 g) to give 50 g available carbohydrates with 200 mL water

Other: Control (study 2)

Test (study 2)

EXPERIMENTAL

The test meals will comprise 109 g white bread plus 50 mg oleuropein from olives

Dietary Supplement: Test (study 2)

Control (study 3)

PLACEBO COMPARATOR

Control will be whole-meal bread (132 g) to give 50 g available carbohydrates with 200 mL water

Other: Control (study 3)

Test (study 3)

EXPERIMENTAL

The test meals will comprise whole-meal bread (132 g) with 50 mg oleuropein dissolved in 200 mL water

Dietary Supplement: Test (study 3)

Control (study 4)

PLACEBO COMPARATOR

Control will be 50 g sucrose dissolved in 200 mL water

Other: Control (study 4)

Test (study 4)

EXPERIMENTAL

The test meals will comprise 50 mg oleuropein and 50 g sucrose dissolved in 200 ml water

Dietary Supplement: Test (study 4)

Control (study 5)

PLACEBO COMPARATOR

Control will be 25 g sucrose dissolved in 200 mL water

Other: Control (study 5)

Test (study 5)

EXPERIMENTAL

The test meals will comprise 160 mg oleuropein and 25 g sucrose dissolved in 200 ml water

Other: Test (study 5)

Control (study 6)

PLACEBO COMPARATOR

Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit

Other: Control (study 6)

Test (study 6)

EXPERIMENTAL

High carbohydrate diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit

Other: Test (study 6)

Control (study 7)

PLACEBO COMPARATOR

Normal diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit

Other: Control (study 7)

Test (study 7)

EXPERIMENTAL

High fat diet 3 days prior to study visit with 109 g bread with 200 ml water on study visit

Other: Test (study 7)

Interventions

Control (study 1)OTHER

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

Control (study 1)
Test (study 1)OTHER

The test meal will comprise 50 g glucose in 200 ml water plus 50 mg oleuropein from olives

Test (study 1)
Control (study 2)OTHER

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

Control (study 2)
Test (study 2)DIETARY_SUPPLEMENT

The test meal will comprise 109 g white bread plus 50 mg oleuropein from olives dissolved in 200 ml water

Test (study 2)
Control (study 3)OTHER

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

Control (study 3)
Test (study 3)DIETARY_SUPPLEMENT

The test meal will comprise whole-meal bread plus 50 mg oleuropein from olives dissolved in 200 ml water

Test (study 3)
Control (study 4)OTHER

Control meal will comprise 50 g sucrose in 200 ml water, to which the response of the test meals will be compared to

Control (study 4)
Test (study 4)DIETARY_SUPPLEMENT

The test meal will comprise 50 g sucrose in 200 ml water plus 50 mg oleuropein from olives

Test (study 4)
Control (study 5)OTHER

Control meal will comprise 25 g sucrose in 200 ml water, to which the response of the test meals will be compared to

Control (study 5)
Test (study 5)OTHER

The test meal will comprise 25 g sucrose in 200 ml water plus 160 mg oleuropein from olives

Test (study 5)
Control (study 6)OTHER

Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day

Control (study 6)
Test (study 6)OTHER

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

Test (study 6)
Control (study 7)OTHER

Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day

Control (study 7)
Test (study 7)OTHER

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

Test (study 7)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gary Williamson

    University of Leeds

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Gary Williamson

Study Record Dates

First Submitted

March 22, 2017

First Posted

March 28, 2017

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share