Type 2 DiabetesNCT02291250
Effect of Soft Fruit on Postprandial Blood Glucose
A study testing Blackcurrants with polycal OGTT, Greencurrants with polycal OGTT and Blackcurrants with glucose OGTT in people with Type 2 Diabetes, run by University of Aberdeen at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Blackcurrants with polycal OGTT, Greencurrants with polycal OGTT and Blackcurrants with glucose OGTT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese male or female (postmenopausal) healthy non-smoking volunteers (BMI over 25kg/m2)
- Aged >21 and <70 years
Who cannot join
- Medical exclusion criteria
- Chronic illness, including:
- thromboembolic or coagulation disease
- unregulated thyroid disease
- kidney disease
- hepatic disease
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Aberdeen Rowett Institute of Nutrition and Health
Aberdeen, AB21 9SB
Nigel Hoggard, PhD, 01224 716655, N.Hoggard@abdn.ac.uk
Nigel Hoggard, PhD
About this study
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 .
Read the 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:
- Control: sugar matched (matched to currant sugar content) water with polycal (complex carbohydrate load)
- Blackcurrants (which contain anthocyanins; 200grams) with polycal (complex carbohydrate load)
- Blackcurrants (which contain anthocyanins; 200grams) with glucose (simple carbohydrate load)
- 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Blackcurrants with polycal OGTT, Greencurrants with polycal OGTT, Blackcurrants with glucose OGTT, Sugar matched water with polycal OGTT
- Keywords
- anthocyanin, blackcurrant, greencurrant, glucose, polyphenol, post prandial glucose
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackcurrants with polycal OGTTDietary supplement
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
Greencurrants with polycal OGTTDietary supplement
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
Blackcurrants with glucose OGTTDietary supplement
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
Sugar matched water with polycal OGTTDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Sugar matched water with polycal OGTT | Experimental | 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 Receives: Dietary Supplement: Sugar matched water with polycal OGTT |
| Blackcurrants with polycal OGTT | Experimental | 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 Receives: Dietary Supplement: Blackcurrants with polycal OGTT |
| Blackcurrants with glucose OGTT | Experimental | 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 Receives: Dietary Supplement: Blackcurrants with glucose OGTT |
| Greencurrants with polycal OGTT | Experimental | 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. Receives: Dietary Supplement: Greencurrants with polycal OGTT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Glucose Area Under the Curve
Measured: 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 outcomes (1)
Plasma Insulin Area Under the Curve
Measured: Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291250
- Sponsor's protocol ID
- Rowett 905
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2014
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soft Fruit on Postprandial Blood Glucose
- ClinicalTrials.gov ID
- NCT02291250
- Acronym / sponsor ID
- Rowett 905
- Conditions
- Type 2 Diabetes
- Keywords
- anthocyanin, blackcurrant, greencurrant, glucose, polyphenol, post prandial glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Control: sugar matched (matched to currant sugar content) water with polycal (complex carbohydrate load)
- Blackcurrants (which contain anthocyanins; 200grams) with polycal (complex carbohydrate load)
- Blackcurrants (which contain anthocyanins; 200grams) with glucose (simple carbohydrate load)
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugar matched water with polycal OGTT | Experimental | Dietary Supplement: Sugar matched water with polycal OGTT1. 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 |
| Blackcurrants with polycal OGTT | Experimental | Dietary Supplement: Blackcurrants with polycal OGTT1. 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 |
| Blackcurrants with glucose OGTT | Experimental | Dietary Supplement: Blackcurrants with glucose OGTT1. 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 |
| Greencurrants with polycal OGTT | Experimental | Dietary Supplement: Greencurrants with polycal OGTT1. 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. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese male or female (postmenopausal) healthy non-smoking volunteers (BMI over 25kg/m2)
- Aged >21 and <70 years
Key exclusion criteria (20 listed)
- Medical exclusion criteria
- Chronic illness, including:
- Alcohol or any other substance abuse
- Eating disorders
- Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blackcurrants with polycal OGTTSixteen 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 polycal OGTT |
| Greencurrants with polycal OGTTSixteen 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 |
| Blackcurrants with glucose OGTTSixteen 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 |
| Sugar matched water with polycal OGTTSixteen 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 |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blackcurrants with polycal OGTT, Greencurrants with polycal OGTT and Blackcurrants with glucose OGTT in people with Type 2 Diabetes, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nigel Hoggard, PhD ([+44] (0) 1224 438655, N.Hoggard@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.