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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento Científico e Tecnológico | OTHER_GOV |
| University of Campinas, Brazil | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control drink | Placebo Comparator | 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. |
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| Berry peel drink | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berry peel drink | Dietary Supplement |
| ||
| Control drink |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial blood glucose response after acute intervention | The capillary blood will be collected for glucose analysis using a glucometer. | -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal. |
| Incremental area under curve (iAUC) blood glucose response after long-term intervention | The capillary blood will be collected for glucose analysis using a glucometer. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial serum insulin response after acute intervention | The capillary blood will be collected for insulin analysis using commercial ELISA kits | -30, 0, 15, 30, 45, 60, 120, and 180 min. |
| Incremental area under curve (iAUC) serum insulin response after long-term intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela G Batista, MSc | Lund University; University of Campinas | Study Chair |
| Yoghatama Cindya Zanzer, MSc | Lund University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Food for Health Science Centre (Medicon Village) - Lund University | Lund | Skåne County | 221 00 | Sweden |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The capillary blood will be collected for insulin analysis using commercial ELISA kits |
| 4 weeks |
| Postprandial subjective appetite rating after acute intervention | Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS). | -30, 0, 15, 30, 45, 60, 120, and 180 min. |
| Incremental area under curve (iAUC) subjective appetite rating after long-term intervention | Appetite will be assessed using standard subjective 100mm visual analogue scaled (VAS). | 4 weeks |
| Postprandial C-reactive protein (CRP) after acute intervention | The venous blood will be collected for CRP analysis using ELISA commercial kits | -30, 60, 120, and 180 min. |
| 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 | 4 weeks |
| Postprandial adiponectin after acute intervention | The venous blood will be collected for adiponectin analysis using ELISA commercial kits | -30, 0, 60, 120, and 180 min. |
| Postprandial adiponectin after long-term intervention with berry peel | The venous blood will be collected for adiponectin analysis using ELISA commercial kits | 4 weeks |
| 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. | 180 min after challenge meal. |
| 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. | -30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry) |
| 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. | 45, 90, and 180 min after challenge meal. |
| Postprandial interleukin-6 (IL-6) after acute intervention | The venous blood will be collected for IL-6 analysis using ELISA commercial kits | -30, 60, 120, and 180 min. |
| 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 | 4 weeks |