Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 23 February 2016
• Main ID: NCT02533986
• Date of registration: 20/08/2015
• Prospective Registration: No
• Primary sponsor: Lund University
• Public title: Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
• Scientific title: Effects of Berry Peel Intake on Glucose Metabolism in Healthy Subjects
• Date of first enrolment: August 2015
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02533986
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
• Phase: Phase 1/Phase 2

Countries of recruitment

Sweden

Contacts

• Name: Angela G Batista, MSc
• Affiliation: Lund University; University of Campinas

• Name: Yoghatama Cindya Zanzer, MSc
• Affiliation: Lund University

Key inclusion & exclusion 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
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Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Dietary Supplement: Berry peel drink

Dietary Supplement: Control drink

Primary Outcome(s)

Incremental area under curve (iAUC) blood glucose response after long-term intervention [Time Frame: 4 weeks]

Postprandial blood glucose response after acute intervention [Time Frame: -30, 0, 15, 30, 45, 60, 120, and 180 min after challenge meal.]

Secondary Outcome(s)

Incremental area under curve (iAUC) of C-reactive protein (CRP) after long-term intervention [Time Frame: 4 weeks]

Postprandial C-reactive protein (CRP) after acute intervention [Time Frame: -30, 60, 120, and 180 min.]

Postprandial adiponectin after acute intervention [Time Frame: -30, 0, 60, 120, and 180 min.]

Incremental area under curve (iAUC) of interleukin-6 (IL-6) after long-term intervention [Time Frame: 4 weeks]

Postprandial adiponectin after long-term intervention with berry peel [Time Frame: 4 weeks]

Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after acute intervention [Time Frame: 180 min after challenge meal.]

Peripheral blood mononuclear cells (PBMCs) inflammatory genes expression after long-term intervention [Time Frame: -30 min. (Day-28 control); 180 min. (Day-28 control); -30 min. (Day-28 berry); 180 min. (Day-28 berry)]

Incremental area under curve (iAUC) subjective appetite rating after long-term intervention [Time Frame: 4 weeks]

Postprandial interleukin-6 (IL-6) after acute intervention [Time Frame: -30, 60, 120, and 180 min.]

Postprandial selective attention after long-term intervention [Time Frame: 45, 90, and 180 min after challenge meal.]

Incremental area under curve (iAUC) serum insulin response after long-term intervention [Time Frame: 4 weeks]

Postprandial serum insulin response after acute intervention [Time Frame: -30, 0, 15, 30, 45, 60, 120, and 180 min.]

Postprandial subjective appetite rating after acute intervention [Time Frame: -30, 0, 15, 30, 45, 60, 120, and 180 min.]

Secondary ID(s)

COGBERRY-BR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Campinas, Brazil

Conselho Nacional de Desenvolvimento Científico e Tecnológico