Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acute Study of Anthocyanin-rich Bilberry and Polyphenol-rich Apple Extracts on Postprandial Glycaemic Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04004182
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:

Strategies to control chronic postprandial hyperglycaemia by optimizing the functionality of foods would strengthen efforts to reduce the risk of developing T2D in the general population. Polyphenolic constituents, may help to delay starch and disaccharide digestion and glucose absorption following a carbohydrate-containing meal or beverage. In vitro studies suggest that some berry anthocyanins and apple polyphenols are effective inhibitors of digestive enzymes, α-amylases and α-glucosidases. Furthermore, polyphenols found in berries and apples inhibit the action of intestinal glucose transporters. Human data is limited; however, randomized controlled trials (RCTs) have shown that berries and apple products reduced postprandial glucose concentrations following consumption of either starch, glucose or sucrose loads.

The aim of this study is to test the hypothesis that consumption of a fruit bar containing anthocyanin-rich bilberry and polyphenol-rich apple extracts together with a starch and sucrose meal would reduce the postprandial glycemic response.

This study is a randomized cross over study and will aim to recruit 24 overweight (BMI > 25.0), men or post-menopausal women, aged ≥40 and ≤ 70 years who will attend four study sessions. The first study session will be an oral glucose tolerance test (OGTT) and the remaining three will be identical in all respects except for the composition of the fruit bar. Consecutive blood samples will be collected in all 4 study sessions which will be used to measure glucose, insulin, C-peptide, incretins and lipids.


Condition or disease Intervention/treatment Phase
Glucose Intolerance Glucose Metabolism Disorders Dietary Supplement: Fruit bar with addition of polyphenols Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This acute intervention study will have a randomised controlled crossover design where the volunteers will return for 4 stand-alone study sessions
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Study of Anthocyanin-rich Bilberry and Polyphenol-rich Apple Extracts on Postprandial Glycaemic Response
Actual Study Start Date : June 8, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OGTT session
Oral Glucose Tolerance test (OGTT)
Dietary Supplement: Fruit bar with addition of polyphenols
Fruit bar with addition of 600mg bilberry anthocyanins and 1200mg apple polyphenols

Active Comparator: Fruit bar
Fruit bar Plus Oral Glucose Tolerance test (OGTT)
Dietary Supplement: Fruit bar with addition of polyphenols
Fruit bar with addition of 600mg bilberry anthocyanins and 1200mg apple polyphenols

Experimental: Fruit bar with bilberry
Fruit bar with addition of 600 mg bilberry anthocyanins Plus Oral Glucose Tolerance test (OGTT)
Dietary Supplement: Fruit bar with addition of polyphenols
Fruit bar with addition of 600mg bilberry anthocyanins and 1200mg apple polyphenols

Experimental: Fruit bar with bilberry and apple
Fruit bar with addition of 600mg bilberry anthocyanins and 1200mg apple polyphenols Plus Oral Glucose Tolerance test (OGTT)
Dietary Supplement: Fruit bar with addition of polyphenols
Fruit bar with addition of 600mg bilberry anthocyanins and 1200mg apple polyphenols




Primary Outcome Measures :
  1. Glucose [ Time Frame: Over 3 hours post OGTT ]
    Changes postprandial blood glucose

  2. Insulin [ Time Frame: Over 3 hours post OGTT ]
    Changes postprandial blood glucose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men or post-menopausal women
  • Aged ≥40 and ≤ 70 years old.
  • BMI > 25.0kg/m2
  • HbA1c <6.5%

Exclusion Criteria:

Those with any of the following will be excluded from participation:

  • Thromboembolic or coagulation disease
  • Unregulated thyroid disease
  • Kidney disease
  • Hepatic disease
  • Severe gastrointestinal disorders
  • Pulmonary disease (e.g. chronic bronchitis, COPD, pacemaker implant)
  • Nut or date allergy
  • Alcohol or any other substance abuse
  • Eating disorders
  • Women who are lactating or breastfeeding, pregnant
  • Allergic/intolerant to foods provided in the study
  • Alcohol and/or other substance abuse
  • Smoking and the use of e-cigarettes
  • Physically active at a competitive level (exercising strenuously on a daily basis for long periods of time)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004182


Contacts
Layout table for location contacts
Contact: Nigel Hoggard, PhD N.Hoggard@abdn.ac.uk

Locations
Layout table for location information
United Kingdom
University of Aberdeen Rowett Institute of Nutrition and Health Recruiting
Aberdeen, United Kingdom, AB21 9SB
Contact: Human studies manager         
Contact       b.deroos@abdn.ac.uk   
Principal Investigator: Nigel Hoggard, PhD         
Sponsors and Collaborators
University of Aberdeen
Layout table for additonal information
Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT04004182    
Other Study ID Numbers: 2019/ROW_Berry/3
The Fruit Bar study ( Other Identifier: Rowett Institute )
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Initially via publication in journal and then via this site

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases
Glucose Metabolism Disorders
Glucose Intolerance
Hyperglycemia