AzTrials
AzTrials

HealthyPhase 1/2NCT02533986

Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

A Phase 1/2 study testing Berry peel drink in people with Healthy, run by Lund University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective of this study is to investigate the effect of a 4-weeks intake of berry peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The berry peel product will be compared with a placebo in a single-blind, cross-over design. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Berry peel drink
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteSweden
Study dates
Aug 2015to Jan 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males and females
  • Signed informed consent
  • BMI 25-30 kg/m2
  • Must be able to accept plant-based foods/drinks

Who cannot join

  • Below 18 years or above 40 years
  • Smoking or using snuff
  • vegetarian or vegan
  • Stressed by venous blood sampling or previous experience of being difficult canulation

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Food for Health Science Centre (Medicon Village) - Lund University

    Lund, Skåne County, 221 00

Other trials in Sweden

About this study

The main objective of this study is to investigate the effect of a 4-weeks intake of berry peel powder on fasting and postprandial glucose metabolism and inflammatory markers. The berry peel product will be compared with a placebo in a single-blind, cross-over design. Furthermore, inflammation-related peripheral blood mononuclear cells (PBMCs) genes expression, appetite and cognitive performance will be included as a pilot study. Investigators hypothesize that long-term consumption of polyphenols and fibres of berry peel will exhibit both direct and indirect actions in healthy overweight subjects by improvement of glucose-associated markers as well as ameliorating inflammation. Moreover, above metabolic markers will correlated with improvements in inflammation-related PBMCs genes expression, subjective appetite and cognitive performance after long-term consumption of berry peel as a source of polyphenols.

Conditions
Healthy
Being tested
Berry peel drink, Control drink
Keywords
Berry, Inflammation, Cognition, Polyphenols, Appetite, Glucose metabolism
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Berry peel drinkDietary supplement

  • Control drinkDietary supplement

Study groups in NCT02533986
Study groupRoleWhat they receive
Control drinkPlacebo comparatorDietary supplement: Control drink As control, subjects are asked to consume 150 ml control drink containing equal amount of insoluble fiber (cellulose) and sugar for 28 days. In addition, on days-1 and 28, subjects will receive an acute challenge of placebo drink at our clinical facility. After 30 min. control drink intake, subjects will be given standardized breakfast corresponding to 50 g available carbohydrates.
Receives: Dietary Supplement: Control drink
Berry peel drinkExperimentalDietary supplement: Berry peel drink Subjects are asked to consume 150 ml experimental drink containing a berry peel fruit powder. In addition, on days-1 and 28, subjects will receive an acute challenge of test drink at our clinical facility. After 30 min. berry drink intake, subjects will be given standardized breakfast corresponding to 50 g available carbohydrates.
Receives: Dietary Supplement: Berry peel drink

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postprandial blood glucose response after acute intervention

    The capillary blood will be collected for glucose analysis using a glucometer.

    Measured: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.

  2. Incremental area under curve (iAUC) blood glucose response after long-term intervention

    The capillary blood will be collected for glucose analysis using a glucometer.

    Measured: 4 weeks

Secondary outcomes (13)

  1. Postprandial serum insulin response after acute intervention

    The capillary blood will be collected for insulin analysis using commercial ELISA kits

    Measured: -30, 0, 15, 30, 45, 60, 120, and 180 min.

  2. Incremental area under curve (iAUC) serum insulin response after long-term intervention

    The capillary blood will be collected for insulin analysis using commercial ELISA kits

    Measured: 4 weeks

  3. Postprandial subjective appetite rating after acute intervention

    Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).

    Measured: -30, 0, 15, 30, 45, 60, 120, and 180 min.

  4. Incremental area under curve (iAUC) subjective appetite rating after long-term intervention

    Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS).

    Measured: 4 weeks

  5. Postprandial C-reactive protein (CRP) after acute intervention

    The venous blood will be collected for CRP analysis using ELISA commercial kits

    Measured: -30, 60, 120, and 180 min.

  6. Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention

    The venous blood will be collected for inflammatory analysis using ELISA commercial kits

    Measured: 4 weeks

  7. Postprandial adiponectin after acute intervention

    The venous blood will be collected for adiponectin analysis using ELISA commercial kits

    Measured: -30, 0, 60, 120, and 180 min.

  8. Postprandial adiponectin after long-term intervention with berry peel

    The venous blood will be collected for adiponectin analysis using ELISA commercial kits

    Measured: 4 weeks

  9. Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention

    The venous blood samples will be taken for isolation of peripheral blood mononuclear cells (PBMCs). Extracted total RNA will then be used for running quantitative-PCR.

    Measured: 180 min after challenge meal.

  10. Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention

    The venous blood samples will be taken for isolation of peripheral blood mononuclear cells (PBMCs). Extracted total RNA will then be used for running quantitative-PCR.

    Measured: -30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)

  11. Postprandial selective attention after long-term intervention

    The selective attention will be assessed using a standardized software (Röd and Grön software) that measures wrong/right decisions and time of reaction when the subjects is faced with a challenging stimulus.

    Measured: 45, 90, and 180 min after challenge meal.

  12. Postprandial interleukin-6 (IL-6) after acute intervention

    The venous blood will be collected for IL-6 analysis using ELISA commercial kits

    Measured: -30, 60, 120, and 180 min.

  13. Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention

    The venous blood will be collected for IL-6 analysis using ELISA commercial kits

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionDec 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02533986
Sponsor's protocol ID
COGBERRY-BR
Status last verified
Feb 2016
First submitted
20 Aug 2015
Last updated
11 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Berry peel drink in people with Healthy, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial blood glucose response after acute intervention (time frame: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02533986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in