CompletedNCT02388503Updated May 1, 2015

The Effect of a Natural Extract on the Post-prandial Blood Glucose Response After Bread Consumption: a Dose-response of Efficacy

An interventional study of no added fruit extract and fruit extract in Healthy, sponsored by Unilever R&D. Completed at 1 site in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-01.

Sponsored by Unilever R&D · Not applicable, Interventional, and Basic science

Phase: Not applicable
Study type: Interventional
Enrollment: 64
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

This study is designed to identify the minimal effective tested dose of fruit extract consumed with a bread which provides a reduction in venous post-prandial blood glucose compared to a reference bread.

Conditions studied

Healthy

Keywords

Blood glucose

In context

Lead sponsor

Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2.
Apparently healthy males and females: no medical conditions which might affect the study measurements including diabetes type 1 and type 2, gastrointestinal dysfunction, gastrointestinal surgery and inflammatory diseases.
Fasting blood glucose value of subjects ≥ 3.4 and ≤ 6.1 mmol/litre (i.e. 62-110 mg/dl) at screening.

Exclusion criteria

Exclusion criteria:

Use of antibiotics within 3 months before day 1; use of any other medication except paracetamol, within 14 days before day 1.
Blood donation in the past 3 months and/or during the study.
Reported intense sporting activities > 10 h/week.
Consumption of > 14 units (female subjects) and > 21 units (male subjects) alcoholic drinks in a typical week.
Reported dietary habits: medically prescribed diet, slimming diet, not used to eat 3 meals a day, vegetarian.
If female, is pregnant (or has been pregnant during the last \< 3 months) or will be planning pregnancy during the study period.
If female, is lactating or has been lactating in the 6 weeks before screening and/or during the study period.
Dislike, known allergy or intolerance to test products or other food products provided during the study.

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 64 participants (actual)

Study arms

Placebo comparator
Reference
No added fruit extract
Dietary Supplement: no added fruit extract
Active comparator
Active 1
lowest dose of fruit extract
Dietary Supplement: fruit extract
Active comparator
Active 2
low dose of fruit extract
Dietary Supplement: fruit extract
Active comparator
Active 3
medium dose of fruit extract
Dietary Supplement: fruit extract
Active comparator
Active 4
high dose of fruit extract
Dietary Supplement: fruit extract

Interventions

Dietary supplementno added fruit extract
Dietary supplementfruit extract
Dietary supplementfruit extract
Dietary supplementfruit extract
Dietary supplementfruit extract

What researchers measure

Primary outcomes

Positive incremental post-prandial blood glucose area under the curve
Time frame: 120 minutes

Secondary outcomes

Post-prandial insulin response
Time frame: 120 minutes
Post-prandial insulin response
Time frame: 180 minutes
AUC of fruit extract calculated by a non-compartmental model
Time frame: 180 minutes
AUC of fruit extract calculated by a population model
Time frame: 180 minutes
Positive incremental post-prandial blood glucose area under the curve
Time frame: 180 minutes

Study locations

1 site

Charité research organisation
Berlin, Charitéplatz 1 10117, Germany

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02388503
Lead sponsor: Unilever R&D
Responsible party: Sponsor
First posted: Mar 17, 2015
Start date: Feb 2015
Primary completion: Mar 2015
Completion: Mar 2015
Last update: May 1, 2015

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Unilever R&D

Start the discussion