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Effects of Lignan-rich Diet on Cardiometabolic Risk Factors

NCT ID: NCT02987595

Last Updated: 2016-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Metabolic Syndrome Overweight Central Obesity Impaired Glucose Tolerance

Keywords

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intervention lignans whole-grain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Whole-grain rye, high lignan

Intervention Type OTHER

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 Type OTHER

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

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

Group Type EXPERIMENTAL

Whole-grain rye, high lignan

Intervention Type OTHER

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 Type OTHER

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

Interventions

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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

Intervention Type OTHER

Whole-grain wheat, low lignan

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish University of Agricultural Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr. Rikard Landberg

Associate professor, Head of Unit Food and Health, Department of Food Science, Swedish University of Agricultural Sciences (SLU)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rikard Landberg

Role: PRINCIPAL_INVESTIGATOR

Swedish University of Agricultural Sciences

Locations

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

Uppsala, Uppsala County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 32097450 (View on PubMed)

Other Identifiers

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SwedishUAS

Identifier Type: -

Identifier Source: org_study_id