Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Lund University
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Postprandial blood glucose response after acute intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control drink
Dietary 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.
Intervention: Control drink (Dietary Supplement)
Berry peel drink
Dietary 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.
Intervention: Berry peel drink (Dietary Supplement)
Outcomes
Primary Outcomes
Postprandial blood glucose response after acute intervention
Time Frame: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.
The capillary blood will be collected for glucose analysis using a glucometer.
Incremental area under curve (iAUC) blood glucose response after long-term intervention
Time Frame: 4 weeks
The capillary blood will be collected for glucose analysis using a glucometer.
Secondary Outcomes
- Postprandial subjective appetite rating after acute intervention(-30, 0, 15, 30, 45, 60, 120, and 180 min.)
- Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention(4 weeks)
- Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention(4 weeks)
- Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention(180 min after challenge meal.)
- Postprandial interleukin-6 (IL-6) after acute intervention(-30, 60, 120, and 180 min.)
- Postprandial adiponectin after acute intervention(-30, 0, 60, 120, and 180 min.)
- Postprandial selective attention after long-term intervention(45, 90, and 180 min after challenge meal.)
- Postprandial serum insulin response after acute intervention(-30, 0, 15, 30, 45, 60, 120, and 180 min.)
- Incremental area under curve (iAUC) serum insulin response after long-term intervention(4 weeks)
- Incremental area under curve (iAUC) subjective appetite rating after long-term intervention(4 weeks)
- Postprandial C-reactive protein (CRP) after acute intervention(-30, 60, 120, and 180 min.)
- Postprandial adiponectin after long-term intervention with berry peel(4 weeks)
- Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention(-30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry))
Investigators
Elin Östman
Assoc. Prof., PhD
Lund University