Effects of Lignan-rich Diet on Cardiometabolic Risk Factors

Metabolic Syndrome Clinical Trial

Official title:

Effects of Lignan-rich Diet on Cardiometabolic Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987595
• Other study ID #: SwedishUAS
• Status: Completed
• Phase: N/A
• First received: June 16, 2015
• Last updated: December 6, 2016
• Start date: June 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Swedish University of Agricultural Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Central Obesity
• Glucose Intolerance
• Impaired Glucose Tolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Obesity, Abdominal
• Overweight

Intervention

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

Locations

Country	Name	City	State
Sweden	Paediatric Research Facility; The Children's Hospital at Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Swedish University of Agricultural Sciences

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose levels		8 weeks	No
Secondary	Blood lipids		8 weeks	No
Secondary	Inflammatory markers		8 weeks	No
Secondary	Oxidative stress markers		8 weeks	No
Secondary	Enterolignans in blood and urine		8 weeks	No