Effect of Soft Fruit on Postprandial Blood Glucose

NCT ID: NCT02291250

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2022-09-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Sugar matched water with polycal OGTT

Intervention Type: DIETARY_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 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

Group Type: EXPERIMENTAL

Blackcurrants with polycal OGTT

Intervention Type: DIETARY_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 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

Group Type: EXPERIMENTAL

Blackcurrants with glucose OGTT

Intervention Type: DIETARY_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 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.

Group Type: EXPERIMENTAL

Greencurrants with polycal OGTT

Intervention Type: DIETARY_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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

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
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Nigel Hoggard, PhD

Role: CONTACT

N.Hoggard@abdn.ac.uk

[+44] (0) 1224 438655

Facility Contacts

Nigel Hoggard, PhD

Role: primary

N.Hoggard@abdn.ac.uk

01224 716655

Other Identifiers

Rowett 905

Identifier Type: -

Identifier Source: org_study_id