Effects of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

This study has been completed.
Sponsor:
Collaborator:
Anti Diabetic Food Centre (Vinn Excellence Centre)
Information provided by (Responsible Party):
Anne Nilsson, Lund University
ClinicalTrials.gov Identifier:
NCT01562392
First received: March 15, 2012
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The purpose of the study is to study the potential anti-inflammatory- and metabolic effects of polyphenols and dietary fibres in a product based on a mixture of several Swedish berries and vegetables that is known to have high amounts of polyphenols and other anit-oxidants. In addition the purpose is to investigate the effects on cognitive functions of the berry product.


Condition Intervention
Metabolic Syndrome
Inflammation
Aging
Fermentation
Dietary Supplement: berries and vegetables
Dietary Supplement: control product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of 5 w Daily Intake of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Working memory test [ Time Frame: 5 week after intervention with test- and control product, respectively ] [ Designated as safety issue: No ]
    Cognitive tests (i.e. working memory) will be executed repeatedly in the morning the day after completing the 5 w (35 days)intervention periods.The tests is executed in the morning after a standardised breakfast. The tests starts 30 min after start of the breakfast and are then performed repeatedly at exact time points after the standardised breakfast.The last cognitive test is executed at 150 min post breakfast.


Secondary Outcome Measures:
  • cardiometabolic risk variables [ Time Frame: cardiometabolic risk variables will be measured the day for start of and the morning after the 5 week (35 d) intervention periods. ] [ Designated as safety issue: No ]
    Inflammatory markers, blood lipids, glucose, insulin, satiety hormons will be determined at fasting in the morning at the first day and the day after completing 5 w (35 days)intervention periods with test product and control product, respectively.

  • oxidative stress [ Time Frame: will be measured the day for start of and the morning after the 5 week (35 d) intervention periods. ] [ Designated as safety issue: No ]
    ox-LDL and MDA will be determined in blood at fasting in the morning at the first day and the day after completing 5 w (35 days)intervention periods with test product and control product, respectively.


Estimated Enrollment: 40
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: berries and vegetables
subjects include specific berries and vegetables in the diet
Dietary Supplement: berries and vegetables
Daily (5 w) supplementation with specific vegetables and berries
Placebo Comparator: control product
Control product with equivalent amounts of carbohydrates but without vegetables and berries.
Dietary Supplement: control product
Supplementation (daily,5 w) with a control product without berries and vegetables.

Detailed Description:

The metabolic syndrome (MetS) includes a cluster of dysfunctions that identifies subjects at risk of developing type-2 diabetes and cardiovascular disease (CVD). A key feature appears to be chronic increased inflammation and activation of the innate system. Consequently, increased low-grade inflammation has been connected to adverse effects on insulin sensitivity, glucose- and lipid metabolism, and blood pressure, and circulating markers of inflammation such as IL-6. A growing body of evidence also link low-grade inflammation to poorer cognitive functioning. Type 2 diabetes, MetS, and glucose intolerance are increasingly being associated with impaired cognition.

Dietary patterns which promote sub-clinical inflammation are increasingly being considered predictive of future risk of CVD and type-2 diabetes. There is a growing insight regarding the role of the colonic micro flora in metabolic regulation and development of low-grade inflammation and obesity. The metabolic cross talk between the colon and peripheral tissues, especially adipose tissue, has been suggested to be regulated through colonic fermentation of indigestible carbohydrates e.g. dietary fibres (DF) and resistant starch. In addition, epidemiological data shows that a high consumption of vegetables and fruits is associated with a lowered risk of cancer and cardiovascular disease, which may be due to the high concentrations of polyphenols or other anti-oxidants that are found in such foods. In addition vegetables and berries are rich in dietary fibres with the potential to beneficially modulate the gut micro flora which may have implication on metabolic risk factors.

In the presently described project it is hypothesized that 5 w daily consumption of a food product containing berries and vegetables can improve metabolic risk variables and cognitive functions. The purpose is therefore to study the potential anti-inflammatory- and metabolic effects, and prebiotic properties, of a food product based on a mixture of several Swedish berries and vegetables that is known to be rich in dietary fibres, polyphenols and other anti-oxidants. In addition the purpose is to investigate the effects on cognitive functions of the food product.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • fasting plasma glucose >6.1
  • known cognitive decline
  • other medications than for treatment of hypertension or hypothyroidism known gastro- intestinal problems
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562392

Locations
Sweden
Applied Nutrition and Food Chemistry, Lund University
Lund, Sweden, SE-22100
Sponsors and Collaborators
Lund University
Anti Diabetic Food Centre (Vinn Excellence Centre)
  More Information

Publications:
Responsible Party: Anne Nilsson, PhD, Lund University
ClinicalTrials.gov Identifier: NCT01562392     History of Changes
Other Study ID Numbers: Dnr 2010/457,2011/510
Study First Received: March 15, 2012
Last Updated: February 26, 2014
Health Authority: Swedwn: Regional Ethical Review Board

Keywords provided by Lund University:
dietary prevention
cognitive performance
metabolic syndrome
colonic fermentation
sub clinical inflammation
cognition and metabolism

Additional relevant MeSH terms:
Inflammation
Metabolic Syndrome X
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014