Effects of Carbohydrase-inhibiting Polyphenols on Glycaemic Response in Vivo

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Leeds
Sponsor:
Information provided by (Responsible Party):
Hilda Nyambe, University of Leeds
ClinicalTrials.gov Identifier:
NCT01994135
First received: November 19, 2013
Last updated: March 27, 2014
Last verified: March 2014

November 19, 2013
March 27, 2014
March 2014
December 2016   (final data collection date for primary outcome measure)
Changes in Incremental Area Under the Curve for glucose, insulin, GIP and GLP-1 will be determined [ Time Frame: Blood will be collected at different time points within 3 hours, twice a week, for two weeks per volunteer ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01994135 on ClinicalTrials.gov Archive Site
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Effects of Carbohydrase-inhibiting Polyphenols on Glycaemic Response in Vivo
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Consumption of carbohydrate containing foods or sugary drinks brings about changes to the blood glucose levels. After a meal or drink, blood glucose levels rise 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.

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.(1)

Research has shown that diets that give rise to a high glucose response are associated with a number of abnormalities like increased metabolic syndrome (2). Metabolic syndrome mostly comprises of insulin resistance and glucose intolerance which gives an increased risk of type 2 diabetes. (3) 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. (4) 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 (5). In vitro 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. (6)

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 polyphenol rich drink/food together with white bread and determine the glycaemic response. The GI of bread will be determined initially as a reference.

Analysis will be done by measuring blood glucose response to white bread alone as reference and then to white bread with test sample containing polyphenols and then determine GI and see how the GI of bread will be affected. Other analyses to be done are plasma insulin, glucagon, gastric inhibitory polypeptide (GIP) and glucagon like peptides-1 (GLP-1) as they all relate to glycaemic response.

Study hypothesis is that glucose metabolism will be affected.

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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Hyperglycaemia
  • Other: Reference food
    Reference food will be used to which test food samples will be compared to.
  • Other: Test food dose 1
  • Other: Test food dose 2
  • Active Comparator: Reference food
    The reference food is white bread
    Intervention: Other: Reference food
  • Experimental: Test food dose 1
    Test food dose 1 response will be compared to reference test food
    Intervention: Other: Test food dose 1
  • Experimental: Test food dose 2
    Test food dose 2 response will be compared to reference test food as well as to test food dose 1
    Intervention: Other: Test food dose 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
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December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Group 1 - Healthy subjects

Not diabetic Fasting glucose (blood glucose level before breakfast) 3.9 -5.9mmol/L Not on long term prescribed medication (except contraceptives) Not pregnant or lactating Not on special diet (for losing weight or fruit extracts supplements) Aged 18-75

Group 2 - Metabolic syndrome risk group

Not diabetic With fasting glucose (blood glucose level before breakfast) in the range of 6.0 - 8.0mmol/l Not on long term prescribed medication (except contraceptives) Not pregnant or lactating Not on special diet (for losing weight or fruit extracts) Aged 18-75

Exclusion Criteria:

  • Group 1 - Healthy subjects

Not healthy Diabetic Fasting glucose (blood glucose level before breakfast) 3.9 -5.9mmol/L On long term prescribed medication (except contraceptives) Pregnant or lactating On special diet (for losing weight or fruit extracts supplements) Aged below 18years or above 75years

Group 2 - Metabolic syndrome risk group

Not diabetic With fasting glucose (blood glucose level before breakfast) above 8.0mmol/l On long term prescribed medication (except contraceptives) Pregnant or lactating On special diet (for losing weight or fruit extracts) Aged below 18years or above 75 years

Both
18 Years to 75 Years
Yes
Contact: Hilda Nyambe +44 1133432957 fs07hs@leeds.ac.uk
United Kingdom
 
NCT01994135
MEEC 12-037
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Hilda Nyambe, University of Leeds
University of Leeds
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Study Chair: Gary Williamson University of Leeds
Principal Investigator: Hilda Nyambe University of Leeds
University of Leeds
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP