Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
Primary Purpose
Metabolic Syndrome, Overweight, Central Obesity
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Whole-grain rye, high lignan
Whole-grain wheat, low lignan
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome focused on measuring intervention, lignans, whole-grain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- smokers
- antibiotic use past 6 months
- cancer diagnose (past 5 years) or other chronic disease diagnosis
- excessive alcohol consumption (>21 units/week)
Sites / Locations
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Whole-grain rye then wheat
Whole-grain wheat then rye
Arm Description
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
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
Outcomes
Primary Outcome Measures
Blood glucose levels
Secondary Outcome Measures
Blood lipids
Inflammatory markers
Oxidative stress markers
Enterolignans in blood and urine
Full Information
NCT ID
NCT02987595
First Posted
June 16, 2015
Last Updated
December 6, 2016
Sponsor
Swedish University of Agricultural Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02987595
Brief Title
Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
Official Title
Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swedish University of Agricultural Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study will be conducted in a randomized, cross-over design (8 wk intervention periods). The lignan-rich diet will be based on whole-grain rye products whereas the control diet will be based on whole-grain wheat products with some added wheat bran. Both diets will provide similar amount of whole grain (g/d) and total dietary fiber content (but dietary fibre quality will be different). Although rye has high lignan content, the aim is to further increase the lignan intake half-way through the whole grain rye intervention period. This will allow us to distinguish the effect of lignans from the effect of whole grain rye as well as evaluating potential differences in effects on cardiometabolic risk factors between whole grain wheat and whole grain rye intake after 4-week consumption. The study design will also allow us to investigate the effects of a putative interaction between microbiome x lignan rich diet and its implication of metabolic risk factors.
Blood samples will be collected by trained nurses at screening, baseline, after 4 weeks and 8 weeks of first intervention period, after wash-out (8 weeks), and after 4 weeks and 8 weeks of the second intervention period.
At each examination day participants will arrive to the test laboratory for blood samples and an oral glucose tolerance test (OGTT) where participants will be given a drink with 75 g of glucose to consume within 10 minutes. Blood samples will be taken after 30, 60 and 120 minutes. Furthermore, participants will be instructed to complete one 3-day weighted food record and also to collect 24-h urine and a fecal sample at week 0, 4, 8, 16, 20 and 24.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Overweight, Central Obesity, Impaired Glucose Tolerance
Keywords
intervention, lignans, whole-grain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole-grain rye then wheat
Arm Type
Experimental
Arm Description
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
Arm Title
Whole-grain wheat then rye
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Whole-grain rye, high lignan
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Whole-grain wheat, low lignan
Intervention Description
Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
Primary Outcome Measure Information:
Title
Blood glucose levels
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Blood lipids
Time Frame
8 weeks
Title
Inflammatory markers
Time Frame
8 weeks
Title
Oxidative stress markers
Time Frame
8 weeks
Title
Enterolignans in blood and urine
Time Frame
8 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
smokers
antibiotic use past 6 months
cancer diagnose (past 5 years) or other chronic disease diagnosis
excessive alcohol consumption (>21 units/week)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rikard Landberg
Organizational Affiliation
Swedish University of Agricultural Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
32097450
Citation
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.
Results Reference
derived
Learn more about this trial
Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
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