NCT01562392

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

March 15, 2012

Last Update Submit

February 26, 2014

Conditions

Metabolic SyndromeInflammationAgingFermentation

Keywords

dietary preventioncognitive performancemetabolic syndromecolonic fermentationsub clinical inflammationcognition and metabolism

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • cardiometabolic risk variables

    cardiometabolic risk variables will be measured the day for start of and the morning after the 5 week (35 d) intervention periods.

  • oxidative stress

    will be measured the day for start of and the morning after the 5 week (35 d) intervention periods.

Study Arms (2)

berries and vegetables

EXPERIMENTAL

subjects include specific berries and vegetables in the diet

Dietary Supplement: berries and vegetables

control product

PLACEBO COMPARATOR

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

Dietary Supplement: control product

Interventions

berries and vegetablesDIETARY_SUPPLEMENT

Daily (5 w) supplementation with specific vegetables and berries

berries and vegetables
control productDIETARY_SUPPLEMENT

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

control product

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy subjects

You may not qualify if:

  • fasting plasma glucose \>6.1
  • known cognitive decline
  • other medications than for treatment of hypertension or hypothyroidism known gastro- intestinal problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Applied Nutrition and Food Chemistry, Lund University

Lund, SE-22100, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 20660279BACKGROUND

  • 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.

    PMID: 20047325BACKGROUND

  • 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.

    PMID: 18356328BACKGROUND

  • 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.

    PMID: 29141041DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Interventions

FruitVegetablesControl Groups

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 15, 2012

First Posted

March 23, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

SE(1)