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Effect of Soft Fruit on Postprandial Blood Glucose

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ClinicalTrials.gov Identifier: NCT02291250
Recruitment Status : Recruiting
First Posted : November 14, 2014
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date April 17, 2019
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Plasma Glucose Area Under the Curve [ Time Frame: Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Plasma Insulin Area Under the Curve [ Time Frame: Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Soft Fruit on Postprandial Blood Glucose
Official Title  ICMJE Effect of Soft Fruit on Postprandial Blood Glucose
Brief Summary Dietary strategies for alleviating health complications associated with type 2 diabetes (T2D) are being pursued as alternatives to pharmaceutical interventions. Berries such as blackcurrants that are rich in polyphenols may influence carbohydrate digestion and absorption and thus postprandial glycaemia. In addition berries have been reported to alter incretins as well as to have anti-oxidant and anti-inflammatory properties that may also affect postprandial glycaemia. This study investigated the acute affect blackcurrants on glucose metabolism in overweight/obese volunteers .
Detailed Description

Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.

There will be a one week minimum wash out period between each intervention. All interventions will be randomised and blinded as far as possible in a cross-over design where the volunteers are acting as their own control. The volunteers will be asked to consume a low phytochemical diet three days prior to taking the currants all occasions. In addition, they will be asked to record what they ate over the same period in a simple food diary.

The following intervention will be carried out on 16 overweight/obese male/postmenopausal female non-smoker volunteers:

  1. Control: sugar matched (matched to currant sugar content) water with polycal (complex carbohydrate load)
  2. Blackcurrants (which contain anthocyanins; 200grams) with polycal (complex carbohydrate load)
  3. Blackcurrants (which contain anthocyanins; 200grams) with glucose (simple carbohydrate load)
  4. Greencurrants (which naturally contain no anthocyanins; 200grams) with polycal (complex carbohydrate load)

Note: the polycal will contain the equivalent glucose load as given in intervention 3 assuming complete hydrolysis of all carbohydrates.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Dietary Supplement: Blackcurrants with polycal OGTT

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.

    The equivalent carbohydrate load will be standardised across the groups

  • Dietary Supplement: Greencurrants with polycal OGTT

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.

    The equivalent carbohydrate load will be standardised across the groups

  • Dietary Supplement: Blackcurrants with glucose OGTT

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.

    The equivalent carbohydrate load will be standardised across the groups

  • Dietary Supplement: Sugar matched water with polycal OGTT

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.

    The equivalent carbohydrate load will be standardised across the groups

Study Arms  ICMJE
  • Experimental: Sugar matched water with polycal OGTT
    1. Control: sugar matched (matched to currant sugar content) water with polycal
    2. Blackcurrants (200grams) with polycal
    3. Blackcurrants (200grams) with glucose
    4. Greencurrants (200grams) with polycal Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load.

    Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments

    Intervention: Dietary Supplement: Sugar matched water with polycal OGTT
  • Experimental: Blackcurrants with polycal OGTT
    1. Blackcurrants (200grams) with polycal
    2. Blackcurrants (200grams) with glucose
    3. Greencurrants ( 200grams) with polycal
    4. Control: sugar matched (matched to currant sugar content) water with polycal

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load as decribed above.

    Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments

    Intervention: Dietary Supplement: Blackcurrants with polycal OGTT
  • Experimental: Blackcurrants with glucose OGTT
    1. Blackcurrants (200grams) with glucose
    2. Greencurrants (200grams) with polycal
    3. Control: sugar matched (matched to currant sugar content) water with polycal
    4. Blackcurrants (200grams) with polycal

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load as decribed above

    Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments

    Intervention: Dietary Supplement: Blackcurrants with glucose OGTT
  • Experimental: Greencurrants with polycal OGTT
    1. Greencurrants (200grams) with polycal
    2. Control: sugar matched (matched to currant sugar content) water with polycal
    3. Blackcurrants (200grams) with polycal
    4. Blackcurrants (200grams) with glucose

    Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.

    The OGTT will be carried out with glucose as a simple carbohydrate load or polycal as a complex carbohydrate load as decribed above.

    Volunteers will be randomised into four groups (n=4 per group). One week wash out between treatments.

    Intervention: Dietary Supplement: Greencurrants with polycal OGTT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2014)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obese male or female (postmenopausal) healthy non-smoking volunteers (BMI over 25kg/m2)
  • Aged >21 and <70 years

Exclusion Criteria:

  • Medical exclusion criteria
  • Chronic illness, including:

    • thromboembolic or coagulation disease
    • unregulated thyroid disease
    • kidney disease
    • hepatic disease
    • severe gastrointestinal disorders
    • pulmonary disease (e.g. chronic bronchitis, COPD)
    • diabetes
  • Alcohol or any other substance abuse
  • Eating disorders
  • Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
  • Non-postmenopausal women
  • Medication exclusion criteria
  • Oral steroids
  • Tricyclic antidepressants, neuroleptics
  • Anticoagulants
  • Digoxin and anti-arrhythmics
  • Chronic use of anti-inflammatories (e.g. high doses of aspirin, ibuprofen), Insulin, -Sulphonylureas, Thiazolidinediones (glitazones), metformin.
  • Anti-obesity medication e.g. Orlistat
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nigel Hoggard, PhD [+44] (0) 1224 438655 N.Hoggard@abdn.ac.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291250
Other Study ID Numbers  ICMJE Rowett 905
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Aberdeen
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Aberdeen
Verification Date April 2019

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