NCT03242876

Brief Summary

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. Therefore a lower glycemic index diet may have benefits in terms of type two diabetes and heart disease management, and as a method for weight loss. There has been some research into the effects of pomegranate on lowering blood glucose responses both chronically and acutely. Mechanistic evidence suggests that this effect could be down to the organic acids found within pomegranate juice. 16 volunteers were fed 50 g available carbohydrate from white bread (109 g), and either 200 ml water (control) or 200 ml solution (test) containing citric acid (3.8 g) and malic acid (119 mg) the quantities that are found in 200 ml pomegranate juice (Biona) as analysed. Blood glucose was measured at baseline, and at 30 - 60 minute increments over three hours. Glucose curves were plotted, and the area under the curve was calculated and compared between conditions for each participant.

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

Timeline
Completed

Started Oct 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 18, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

August 3, 2017

Last Update Submit

April 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incremental area under the glucose curve

    The incremental area under the glucose curve after consumption of the test meal will be compared to that obtained after the control meal

    1 year

Study Arms (2)

Control meal

PLACEBO COMPARATOR

Control will be 109 g white bread and 200 mL water. The glycaemic response to the test meal will be compared to the response of the control meal.

Other: Control

Test meal

EXPERIMENTAL

Test will be 109 g white bread and 200 mL water containing 3.819 g citric acid and 119 mg malic acid adjusted to pH 3.2. The glycaemic response to this meal will be compared to that of the control meal.

Other: Test

Interventions

ControlOTHER

Control will be 109 g white bread to be consumed together with 200 mL water

Control meal
TestOTHER

Test will be 109 g white bread to be consumed together with 3.819 g citric acid and 119 mg malic acid dissolved in 200 mL water adjusted to pH 3.2.

Test meal

Eligibility Criteria

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

You may qualify if:

  • Measured on first visit: Fasting glucose (blood glucose level before breakfast) 3.9 -5.9 mmol/L
  • 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 extract supplements)
  • Aged 18-75

You may not qualify if:

  • Measured fasting plasma glucose \>5.9 mmol/L
  • Not healthy
  • Diabetic
  • Pregnant or lactating
  • On special diet (for losing weight)
  • On long term prescribed medication
  • Smoker
  • Diabetic

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

Related Publications (1)

  • Kerimi A, Nyambe-Silavwe H, Gauer JS, Tomas-Barberan FA, Williamson G. Pomegranate juice, but not an extract, confers a lower glycemic response on a high-glycemic index food: randomized, crossover, controlled trials in healthy subjects. Am J Clin Nutr. 2017 Dec;106(6):1384-1393. doi: 10.3945/ajcn.117.161968. Epub 2017 Oct 11.

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Gary Williamson, PhD

    University of Leeds

    STUDY CHAIR
  • Hilda Nyambe, 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
Prof functional foods

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

October 1, 2016

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations