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

Primary Purpose

Metabolic Syndrome, Inflammation, Aging

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
berries and vegetables
control product
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Metabolic Syndrome focused on measuring dietary prevention, cognitive performance, metabolic syndrome, colonic fermentation, sub clinical inflammation, cognition and metabolism

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Applied Nutrition and Food Chemistry, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

berries and vegetables

control product

Arm Description

subjects include specific berries and vegetables in the diet

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 15, 2012
Last Updated
February 26, 2014
Sponsor
Lund University
Collaborators
Anti-Diabetic Food Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01562392
Brief Title
Effects of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions
Official Title
Effects of 5 w Daily Intake of Berries and Vegetables on Cardiometabolic Risk Markers and Cognitive Functions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Anti-Diabetic Food Centre

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Inflammation, Aging, Fermentation
Keywords
dietary prevention, cognitive performance, metabolic syndrome, colonic fermentation, sub clinical inflammation, cognition and metabolism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
berries and vegetables
Arm Type
Experimental
Arm Description
subjects include specific berries and vegetables in the diet
Arm Title
control product
Arm Type
Placebo Comparator
Arm Description
Control product with equivalent amounts of carbohydrates but without vegetables and berries.
Intervention Type
Dietary Supplement
Intervention Name(s)
berries and vegetables
Intervention Description
Daily (5 w) supplementation with specific vegetables and berries
Intervention Type
Dietary Supplement
Intervention Name(s)
control product
Intervention Description
Supplementation (daily,5 w) with a control product without berries and vegetables.
Primary Outcome Measure Information:
Title
Working memory test
Description
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.
Time Frame
5 week after intervention with test- and control product, respectively
Secondary Outcome Measure Information:
Title
cardiometabolic risk variables
Description
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.
Time Frame
cardiometabolic risk variables will be measured the day for start of and the morning after the 5 week (35 d) intervention periods.
Title
oxidative stress
Description
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.
Time Frame
will be measured the day for start of and the morning after the 5 week (35 d) intervention periods.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Applied Nutrition and Food Chemistry, Lund University
City
Lund
ZIP/Postal Code
SE-22100
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
20660279
Citation
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.
Results Reference
background
PubMed Identifier
20047325
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.
Results Reference
background
PubMed Identifier
18356328
Citation
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.
Results Reference
background
PubMed Identifier
29141041
Citation
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.
Results Reference
derived

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

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