NCT02291250

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2021

Enrollment Period

7.8 years

First QC Date

November 11, 2014

Last Update Submit

February 18, 2021

Conditions

Type 2 Diabetes

Keywords

anthocyaninblackcurrantgreencurrantglucosepolyphenolpost prandial glucose

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (4)

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

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

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

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.

Dietary Supplement: Greencurrants with polycal OGTT

Interventions

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

Blackcurrants with polycal OGTT
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

Greencurrants with polycal OGTT
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

Blackcurrants with glucose OGTT
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

Sugar matched water with polycal OGTT

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen Rowett Institute of Nutrition and Health

Aberdeen, AB21 9SB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Nigel Hoggard, PhD

CONTACT

[+44] (0) 1224 438655N.Hoggard@abdn.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2014

First Posted

November 14, 2014

Study Start

November 1, 2014

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

February 21, 2021

Record last verified: 2021-02

Locations

GB(1)