The Effects of Citric and Malic Acid Found in Pomegranate Juice on Glycaemic Response to White Bread.
1 other identifier
interventional
16
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
1 active site
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
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 18, 2018
April 1, 2018
11 months
August 3, 2017
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 COMPARATORControl 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.
Test meal
EXPERIMENTALTest 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.
Interventions
Eligibility Criteria
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
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.
PMID: 29021286DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gary Williamson, PhD
University of Leeds
- PRINCIPAL INVESTIGATOR
Hilda Nyambe, PhD
University of Leeds
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