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Effects of Lignan-rich Diet on Cardiometabolic Risk Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02987595
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Rikard Landberg, Swedish University of Agricultural Sciences

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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Overweight Central Obesity Impaired Glucose Tolerance Other: Whole-grain rye, high lignan Other: Whole-grain wheat, low lignan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Lignan-rich Diet on Cardiometabolic Risk Factors
Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

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
Other: Whole-grain rye, high lignan
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

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

Other: Whole-grain wheat, low lignan
Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.




Primary Outcome Measures :
  1. Blood glucose levels [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Blood lipids [ Time Frame: 8 weeks ]
  2. Inflammatory markers [ Time Frame: 8 weeks ]
  3. Oxidative stress markers [ Time Frame: 8 weeks ]
  4. Enterolignans in blood and urine [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02987595


Locations
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Sweden
Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Swedish University of Agricultural Sciences
Investigators
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Principal Investigator: Rikard Landberg Swedish University of Agricultural Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Rikard Landberg, Associate professor, Head of Unit Food and Health, Department of Food Science, Swedish University of Agricultural Sciences (SLU), Swedish University of Agricultural Sciences
ClinicalTrials.gov Identifier: NCT02987595    
Other Study ID Numbers: SwedishUAS
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Keywords provided by Dr. Rikard Landberg, Swedish University of Agricultural Sciences:
intervention
lignans
whole-grain
Additional relevant MeSH terms:
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Metabolic Syndrome
Glucose Intolerance
Obesity, Abdominal
Overweight
Body Weight
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Obesity
Overnutrition
Nutrition Disorders