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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01562392
Other study ID # Dnr 2010/457,2011/510
Secondary ID
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


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
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