- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02987595
Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Uppsala, Sweden, SE-751 85
- Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Whole-grain rye then wheat
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
|
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 week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
|
Experimental: Whole-grain wheat then rye
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 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 week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood glucose levels
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood lipids
Time Frame: 8 weeks
|
8 weeks
|
Inflammatory markers
Time Frame: 8 weeks
|
8 weeks
|
Oxidative stress markers
Time Frame: 8 weeks
|
8 weeks
|
Enterolignans in blood and urine
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rikard Landberg, Swedish University of Agricultural Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SwedishUAS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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