Effect of Soft Fruit on Postprandial Blood Glucose

Type 2 Diabetes Clinical Trial

Official title:

Effect of Soft Fruit on Postprandial Blood Glucose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291250
• Other study ID #: Rowett 905
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: September 2022

Study information

• Verified date: February 2021
• Source: University of Aberdeen
• Contact: Nigel Hoggard, PhD
• Phone: [+44] (0) 1224 438655
• Email: N.Hoggard[@]abdn.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	University of Aberdeen Rowett Institute of Nutrition and Health	Aberdeen

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Glucose Area Under the Curve		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	Plasma Insulin Area Under the Curve		Plasma was collected at -15, -10 and -5 (fasted) and at 15, 30, 45, 60, 90, 120, 150 and 300 min post currant ingestion