- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02291250
Effect of Soft Fruit on Postprandial Blood Glucose
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nigel Hoggard, PhD
- Phone Number: [+44] (0) 1224 438655
- Email: N.Hoggard@abdn.ac.uk
Study Locations
-
-
-
Aberdeen, United Kingdom, AB21 9SB
- Recruiting
- University of Aberdeen Rowett Institute of Nutrition and Health
-
Contact:
- Nigel Hoggard, PhD
- Phone Number: 01224 716655
- Email: N.Hoggard@abdn.ac.uk
-
Principal Investigator:
- Nigel Hoggard, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sugar matched water with polycal 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 |
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
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 |
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
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 |
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
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. |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
Outcome Measure |
Time Frame |
---|---|
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
|
Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Rowett 905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
Chengdu Brilliant Pharmaceutical Co., Ltd.Not yet recruitingType 2 Diabetes Mellitus
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
University of Alabama at BirminghamCompletedType 2 Diabetes MellitusUnited States
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
Clinical Trials on Sugar matched water with polycal OGTT
-
University of BrasiliaConselho Nacional de Desenvolvimento Científico e Tecnológico; MRC Human Nutrition...Completed
-
University of CopenhagenCompleted
-
University of MemphisRecruiting
-
Guangzhou Blood CenterCompletedBlood DonationChina
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Weight GainUnited States
-
Instituto de Investigación Sanitaria Gregorio MarañónCompletedAlcohol ConsumptionSpain
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedT2D | IGT - Impaired Glucose ToleranceUnited States
-
Liverpool Heart and Chest Hospital NHS Foundation...Completed