NCT02987595

Brief Summary

Diet plays an important role in relation to prevention of type 2 diabetes, cardiovascular disease and certain cancers. Studies have shown that diets with high whole-grain content could decrease the risk of these lifestyle related diseases and in Sweden the national dietary guidelines recommends whole-grain based instead of refined cereal products. It is, however, not clear whether whole-grain from wheat and rye share similar protective effects since there are large differences in amount and quality of dietary fibre and associated bioactive compounds. The aim of this study is to evaluate the impact of a wholegrain diet with low- or high lignan content on different cardiometabolic risk factors with the primary endpoint being blood glucose levels after 2h oral glucose tolerance test in men with metabolic syndrome or sign thereof.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

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

June 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

June 16, 2015

Last Update Submit

December 6, 2016

Conditions

Metabolic SyndromeOverweightCentral ObesityImpaired Glucose Tolerance

Keywords

interventionlignanswhole-grain

Outcome Measures

Primary Outcomes (1)

  • Blood glucose levels

    8 weeks

Secondary Outcomes (4)

  • Blood lipids

    8 weeks

  • Inflammatory markers

    8 weeks

  • Oxidative stress markers

    8 weeks

  • Enterolignans in blood and urine

    8 weeks

Study Arms (2)

Whole-grain rye then wheat

EXPERIMENTAL

Whole-grain rye, high lignan Whole-grain rye products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain wheat products for 8 weeks

Other: Whole-grain rye, high lignanOther: Whole-grain wheat, low lignan

Whole-grain wheat then rye

EXPERIMENTAL

Whole-grain wheat, low lignan Whole-grain wheat products for 8 weeks, then a wash-out period of 8 weeks, and then whole-grain rye products for 8 weeks

Other: Whole-grain rye, high lignanOther: Whole-grain wheat, low lignan

Interventions

Whole-grain rye, high lignanOTHER

Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta. Additionally for intervention week 4-8: 4 lignan capsules per day

Whole-grain rye then wheatWhole-grain wheat then rye
Whole-grain wheat, low lignanOTHER

Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.

Whole-grain rye then wheatWhole-grain wheat then rye

Eligibility Criteria

Age40 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 25 kg/m2
  • waist circumference \> 102 cm
  • at least one of the following: blood pressure \>130/85 mmHg, serum triglycerides ≥1.69 mmol/L; HDL cholesterol \<1.04 mmol/L; or serum glucose ≥6.1 mmol/L

You may not qualify if:

  • smokers
  • antibiotic use past 6 months
  • cancer diagnose (past 5 years) or other chronic disease diagnosis
  • excessive alcohol consumption (\>21 units/week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital

Uppsala, Uppsala County, SE-751 85, Sweden

Location

Related Publications (1)

  • Eriksen AK, Brunius C, Mazidi M, Hellstrom PM, Riserus U, Iversen KN, Fristedt R, Sun L, Huang Y, Norskov NP, Knudsen KEB, Kyro C, Olsen A, Tjonneland A, Dicksved J, Landberg R. Effects of whole-grain wheat, rye, and lignan supplementation on cardiometabolic risk factors in men with metabolic syndrome: a randomized crossover trial. Am J Clin Nutr. 2020 Apr 1;111(4):864-876. doi: 10.1093/ajcn/nqaa026.

    PMID: 32097450DERIVED

MeSH Terms

Conditions

Metabolic SyndromeOverweightObesity, AbdominalGlucose Intolerance

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsObesityHyperglycemia

Study Officials

  • Rikard Landberg

    Swedish University of Agricultural Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, Head of Unit Food and Health, Department of Food Science, Swedish University of Agricultural Sciences (SLU)

Study Record Dates

First Submitted

June 16, 2015

First Posted

December 9, 2016

Study Start

June 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12

Locations

SE(1)