NCT02669693

Brief Summary

This research is aimed at determining whether the presence of oleuropein in olives (Olea europaea L.) has any lowering effect on post-prandial blood glucose levels. Volunteers will be required to consume commercially available olives together with white bread, and their glycaemic response will be measured. The blood glucose response of bread will be determined initially as a control/reference. Food samples and control will be consumed in random order. The recent rise in the cases of Diabetes mellitus in both children and adults has raised a concern for the need to proffer immediate solutions amongst scientists in the fields of medicine food science and nutrition. One of the approaches of reducing postprandial hyperglycaemia and high glucose spikes is to impede digestion and absorption of starch. This is potentially achieved through the inhibition of the activities of starch digesting enzymes namely alpha amylase and alpha glycosidase. There are currently some antidiabetic drugs such as acarbose and miglitol which have been quite efficient in these inhibitory functions but not without associated side effects and complications such as liver toxicity, etc, arising from to long term usage of such drugs. It therefore becomes imperative for natural substitutes from food sources to be explored as better alternatives. At the moment several plant foods are under investigation as suitable alternatives, and olives appear to be quite promising in this regard. There are quite a few studies that have reported the inhibitory activities of olives oleuropein on alpha amylase in vitro but information on in vivo testing is very scarce. It is expected that the research outcome will be a gateway to the reduction and control of the incidence of diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

January 19, 2016

Last Update Submit

March 22, 2017

Conditions

Keywords

Olives, oleuropein

Outcome Measures

Primary Outcomes (1)

  • Post-prandial blood glucose concentration

    180 minutes

Study Arms (2)

bread without olives

PLACEBO COMPARATOR

Intervention (no olives): Subjects will consume a meal of 109 g white bread and 200 of ml water, and post-prandial blood glucose measured over a 3 hour period.

Dietary Supplement: bread without olives

bread with olives

ACTIVE COMPARATOR

Intervention (olives 100 g): Subjects will consume a meal of 109 g white bread, 100 g of olives and 200 of ml water, and post-prandial blood glucose measured over a 3 hour period.

Dietary Supplement: bread with olives

Interventions

bread without olivesDIETARY_SUPPLEMENT
bread without olives
bread with olivesDIETARY_SUPPLEMENT
bread with olives

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75
  • Fasting glucose (blood glucose level before breakfast) 3.9 -5.9mmol/L

You may not qualify if:

  • Diabetic
  • on long term prescribed medication (except contraceptives)
  • pregnant or lactating
  • on special diet (for losing weight or fruit extracts supplements)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Food Science and Nutrition, University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Bread

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Gary Williamson, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

January 19, 2016

First Posted

February 1, 2016

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations