β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST

Study Overview
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Brief Summary
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The aim of this study is to investigate the potential disease preventive effects of β-glucans from oat and barley.

Detailed Description
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Objective: The primary aim is to examine whether consumption of oat and two different barley β-glucans exhibits hypocholesterolemic effects and to understand the underlying mechanisms. Secondary aims are to investigate whether there are also effects on blood pressure, appetite regulation, insulin sensitivity, hemostasis, low-grade inflammation and the metabolic profile of different biological materials. Intervention: In each of the 4 intervention periods the participants drink a milk drink together with their three main meals for 21 days. This way they consume 5g β-glucan/d form either oat or barley in the three treatment periods, otherwise they maintain their habitual diet. They are not, however, allowed to eat any oat- or barley-containing products during the trial. At the beginning and at the end of each intervention period the participants' blood pressure is measured and a fasting blood sample is drawn. Further they collect feces for 72 hours and urine for 24 hours before and at the end of each intervention period. Before and at the end of each intervention period a 4-hour meal test is undertaken to measure their subject appetite sensation. Here at first a fasting blood samples drawn and thereafter the milk drink is served. Appetite sensation is assessed every 30 min for 4 hours. Also blood samples are drawn at 2 hours and 4 hours at the meal tests which takes place before each intervention period. At the subsequent ad libitum lunch meal the food intake is measured and then a final appetite registration is made. Furthermore participants make 4-d food records before and at the end of each intervention period.

Official Title
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β-Glucans and the Metabolic Syndrome - a Human Intervention Study Under BEST

Conditions
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Healthy

Intervention / Treatment
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* Other: no β-glucan
* Other: oat β-glucan
* Other: barley β-glucan
* Other: mutant-barley β-glucan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: normal weight or moderately overweight (BMI 18.5-30 kg/m²) Exclusion Criteria: chronic diseases (e.g. diabetes, cardiovascular disease) elevated blood pressure hyperlipidemia consumption of dietary supplements during or 2 month prior to start of study (including vitamin tablets) consumption of oat and barley products from January 1st until the end of study smoking excess physical activity (> 8h/week) medicine use (not included contraceptives or occasional pain killer consumption) pregnancy breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo milk drink<br> | Other: no β-glucan<br>* daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days<br>|
| Experimental: Millk drink with oat β-glucan<br> | Other: oat β-glucan<br>* daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days<br>* Other names: PromOat,Biovelop, Kimstad, Sweden;|
| Experimental: Milk drink with barley β-glucan<br> | Other: barley β-glucan<br>* daily consumption of 5g β-glucan extracted from the barley-mutant mother Bomi in the form of milk drinks with the 3 main meals for 21 days<br>|
| Experimental: Milk drink with mutant-barley β-glucan<br> | Other: mutant-barley β-glucan<br>* daily consumption of 5g β-glucan extracted from the high β-glucan barely mutant lys. 5.f in the form of milk drinks with the 3 main meals for 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in total and LDL cholesterol concentration |  | fasting blood sample at baseline and day 21 | 
| pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces) |  | average over three days at baseline and after 3 weeks | 
| weight |  | at baseline and after 1, 2 and 3 weeks | 
| food intake (in 4d records) |  | at baseline and after 3 weeks | 
| height |  | at baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin, glucose, IL-6, CRP, TNF-α, fibrinogen, PAI-1, appetite regulation peptides, alkylresorcinol, metabolomics (in fasting and meal test blood samples) |  | fasting blood sample at baseline and on day 21 | 
| appetite sensation (in meal tests) |  | 3h appetite registrations at baseline and on day 21 | 
| metabolomics, isoprostanes (in 24h urine) |  | at baseline and after 3 weeks | 
| metabolomics (in 72h feces) |  | average over 3 days at baseline and after 3 weeks | 
| blood pressure |  | at baseline and on day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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β-glucan, cholesterol, bile acids, blood glucose, appetite