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

Aging Clinical Trial

Official title:

Effects of 5 w Daily Intake of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562392
• Other study ID #: Dnr 2010/457,2011/510
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: February 26, 2014
• Start date: September 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Swedwn: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Aging
• Fermentation
• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Dietary Supplement:
• berries and vegetables
Daily (5 w) supplementation with specific vegetables and berries
• control product
Supplementation (daily,5 w) with a control product without berries and vegetables.

Locations

Country	Name	City	State
Sweden	Applied Nutrition and Food Chemistry, Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Anti-Diabetic Food Centre

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

Nilsson AC, Ostman EM, Holst JJ, Björck 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working memory test	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.	5 week after intervention with test- and control product, respectively	No
Secondary	cardiometabolic risk variables	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.	cardiometabolic risk variables will be measured the day for start of and the morning after the 5 week (35 d) intervention periods.	No
Secondary	oxidative stress	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.	will be measured the day for start of and the morning after the 5 week (35 d) intervention periods.	No