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

NCT ID: NCT01562392

Last Updated: 2014-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-01-31

Brief Summary

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.

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.

Conditions

Metabolic Syndrome; Inflammation; Aging; Fermentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

berries and vegetables

subjects include specific berries and vegetables in the diet

Group Type: EXPERIMENTAL

berries and vegetables

Intervention Type: DIETARY_SUPPLEMENT

Daily (5 w) supplementation with specific vegetables and berries

control product

Control product with equivalent amounts of carbohydrates but without vegetables and berries.

Group Type: PLACEBO_COMPARATOR

control product

Intervention Type: DIETARY_SUPPLEMENT

Supplementation (daily,5 w) with a control product without berries and vegetables.

Interventions

berries and vegetables

Daily (5 w) supplementation with specific vegetables and berries

Intervention Type: DIETARY_SUPPLEMENT

control product

Supplementation (daily,5 w) with a control product without berries and vegetables.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anti-Diabetic Food Centre

OTHER

Sponsor Role: collaborator

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Anne Nilsson

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Applied Nutrition and Food Chemistry, Lund University

Lund, , Sweden

Countries

Sweden

References

Basu A, Du M, Leyva MJ, Sanchez K, Betts NM, Wu M, Aston CE, Lyons TJ. Blueberries decrease cardiovascular risk factors in obese men and women with metabolic syndrome. J Nutr. 2010 Sep;140(9):1582-7. doi: 10.3945/jn.110.124701. Epub 2010 Jul 21.

Reference Type: BACKGROUND

PMID: 20660279 (View on PubMed)

Krikorian R, Shidler MD, Nash TA, Kalt W, Vinqvist-Tymchuk MR, Shukitt-Hale B, Joseph JA. Blueberry supplementation improves memory in older adults. J Agric Food Chem. 2010 Apr 14;58(7):3996-4000. doi: 10.1021/jf9029332.

Reference Type: BACKGROUND

PMID: 20047325 (View on PubMed)

Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.

Reference Type: BACKGROUND

PMID: 18356328 (View on PubMed)

Nilsson A, Salo I, Plaza M, Bjorck I. Effects of a mixed berry beverage on cognitive functions and cardiometabolic risk markers; A randomized cross-over study in healthy older adults. PLoS One. 2017 Nov 15;12(11):e0188173. doi: 10.1371/journal.pone.0188173. eCollection 2017.

Reference Type: DERIVED

PMID: 29141041 (View on PubMed)

Other Identifiers

Dnr 2010/457,2011/510

Identifier Type: -

Identifier Source: org_study_id