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Effect of Soft Fruit on Postprandial Blood Glucose

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

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 .

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Dietary Supplement: Blackcurrants with polycal OGTT Dietary Supplement: Greencurrants with polycal OGTT Dietary Supplement: Blackcurrants with glucose OGTT Dietary Supplement: Sugar matched water with polycal OGTT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Soft Fruit on Postprandial Blood Glucose
Study Start Date : November 2014
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
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

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


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

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


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

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


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.

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





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02291250


Contacts
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Contact: Nigel Hoggard, PhD [+44] (0) 1224 438655 N.Hoggard@abdn.ac.uk

Locations
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United Kingdom
University of Aberdeen Rowett Institute of Nutrition and Health Recruiting
Aberdeen, United Kingdom, AB21 9SB
Contact: Nigel Hoggard, PhD    01224 716655    N.Hoggard@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: NCT02291250    
Other Study ID Numbers: Rowett 905
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Aberdeen:
anthocyanin
blackcurrant
greencurrant
glucose
polyphenol
post prandial glucose