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

March 15, 2012
February 26, 2014
September 2011
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01562392 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Effects of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions
Effects of 5 w Daily Intake of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Metabolic Syndrome
  • Inflammation
  • Aging
  • Fermentation
  • Dietary Supplement: berries and vegetables
    Daily (5 w) supplementation with specific vegetables and berries
  • Dietary Supplement: control product
    Supplementation (daily,5 w) with a control product without berries and vegetables.
  • Experimental: berries and vegetables
    subjects include specific berries and vegetables in the diet
    Intervention: Dietary Supplement: berries and vegetables
  • Placebo Comparator: control product
    Control product with equivalent amounts of carbohydrates but without vegetables and berries.
    Intervention: Dietary Supplement: control product

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01562392
Dnr 2010/457,2011/510
Not Provided
Anne Nilsson, Lund University
Lund University
Anti Diabetic Food Centre (Vinn Excellence Centre)
Not Provided
Lund University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP