Clinical trial NCT02533986: Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
Official title: Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Berry
Inflammation
Cognition
Polyphenols
Appetite
Glucose metabolism
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: University of Campinas, Brazil
First posted: 2015-08-27
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postprandial blood glucose response after acute intervention
timeFrame: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
measure: Incremental area under curve (iAUC) blood glucose response after long-term intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Postprandial serum insulin response after acute intervention
timeFrame: -30, 0, 15, 30, 45, 60, 120, and 180 min.
measure: Incremental area under curve (iAUC) serum insulin response after long-term intervention
timeFrame: 4 weeks
measure: Postprandial subjective appetite rating after acute intervention
timeFrame: -30, 0, 15, 30, 45, 60, 120, and 180 min.
measure: Incremental area under curve (iAUC) subjective appetite rating after long-term intervention
timeFrame: 4 weeks
measure: Postprandial C-reactive protein (CRP) after acute intervention
timeFrame: -30, 60, 120, and 180 min.
measure: Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention
timeFrame: 4 weeks
measure: Postprandial adiponectin after acute intervention
timeFrame: -30, 0, 60, 120, and 180 min.
measure: Postprandial adiponectin after long-term intervention with berry peel
timeFrame: 4 weeks
measure: Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention
timeFrame: 180 min after challenge meal.
measure: Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention
timeFrame: -30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)
measure: Postprandial selective attention after long-term intervention
timeFrame: 45, 90, and 180 min after challenge meal.
measure: Postprandial interleukin-6 (IL-6) after acute intervention
timeFrame: -30, 60, 120, and 180 min.
measure: Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Science Centre (Medicon Village) - Lund University
state: Skåne
Study officials:
affiliation: Lund University; University of Campinas
name: Angela G Batista, MSc
role: STUDY_CHAIR
affiliation: Lund University
name: Yoghatama Cindya Zanzer, MSc
role: STUDY_CHAIR
References: