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

L

Lund University

Status

Completed

Conditions

Fermentation
Aging
Inflammation
Metabolic Syndrome

Treatments

Dietary Supplement: control product
Dietary Supplement: berries and vegetables

Study type

Interventional

Funder types

Other

Identifiers

NCT01562392
Dnr 2010/457,2011/510

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

berries and vegetables
Experimental group
Description:
subjects include specific berries and vegetables in the diet
Treatment:
Dietary Supplement: berries and vegetables
control product
Placebo Comparator group
Description:
Control product with equivalent amounts of carbohydrates but without vegetables and berries.
Treatment:
Dietary Supplement: control product

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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