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

• ClinicalTrials.gov Identifier: NCT01562392
• Recruitment Status: Completed
• First Posted: March 23, 2012
• Last Update Posted: February 27, 2014
• Sponsor: Lund University
• Collaborator: Anti-Diabetic Food Centre
• Information provided by (Responsible Party): Anne Nilsson, Lund University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome; Inflammation; Aging; Fermentation	Dietary Supplement: berries and vegetables; Dietary Supplement: control product	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of 5 w Daily Intake of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: berries and vegetables; subjects include specific berries and vegetables in the diet	Dietary Supplement: berries and vegetables; Daily (5 w) supplementation with specific vegetables and berries
Placebo Comparator: control product; Control product with equivalent amounts of carbohydrates but without vegetables and berries.	Dietary Supplement: control product; Supplementation (daily,5 w) with a control product without berries and vegetables.

Outcome Measures

Primary Outcome Measures :

1. Working memory test [ Time Frame: 5 week after intervention with test- and control product, respectively ]
   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.

Secondary Outcome Measures :

1. 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. ]
   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.
2. oxidative stress [ Time Frame: will be measured the day for start of and the morning after the 5 week (35 d) intervention periods. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Sweden

Applied Nutrition and Food Chemistry, Lund University

Lund, Sweden, SE-22100

Sponsors and Collaborators

Lund University

Anti-Diabetic Food Centre

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nilsson A, Salo I, Plaza M, Björck 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.

• Responsible Party: Anne Nilsson, PhD, Lund University
• ClinicalTrials.gov Identifier: NCT01562392
• Other Study ID Numbers: Dnr 2010/457,2011/510
• First Posted: March 23, 2012
• Last Update Posted: February 27, 2014
• Last Verified: February 2014

Keywords provided by Anne Nilsson, Lund University:

dietary prevention; cognitive performance; metabolic syndrome; colonic fermentation; sub clinical inflammation; cognition and metabolism

Additional relevant MeSH terms:

Metabolic Syndrome; Inflammation; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases