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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317264
• Other study ID #: M196
• Status: Completed
• Phase: N/A
• First received: March 11, 2011
• Last updated: March 16, 2011
• Start date: November 2009
• Est. completion date: March 2011

Study information

• Verified date: November 2009
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy
• Metabolic Syndrome X

Intervention

Other:
• no ß-glucan
daily consumption of non-ß-glucan containing milk drinks together with the 3 main meals for 21 days
• oat ß-glucan
daily consumption of 5g of oat ß-glucan in the form of milk drinks with the 3 main meals for 21 days
• barley ß-glucan
daily consumption of 5g ß-glucan extracted from the barley-mutant mother "Bomi" in the form of milk drinks with the 3 main meals for 21 days
• mutant-barley ß-glucan
daily consumption of 5g ß-glucan extracted from the high ß-glucan barely mutant "lys. 5.f" in the form of milk drinks with the 3 main meals for 21 days

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in total and LDL cholesterol concentration		fasting blood sample at baseline and day 21	No
Primary	pH, SCFA, bile acids, total fat, total energy, cholesterol (in 72h feces)		average over three days at baseline and after 3 weeks	No
Primary	weight		at baseline and after 1, 2 and 3 weeks	No
Primary	food intake (in 4d records)		at baseline and after 3 weeks	No
Primary	height		at baseline	No
Secondary	insulin, glucose, IL-6, CRP, TNF-a, fibrinogen, PAI-1, appetite regulation peptides, alkylresorcinol, metabolomics (in fasting and meal test blood samples)		fasting blood sample at baseline and on day 21	No
Secondary	appetite sensation (in meal tests)		3h appetite registrations at baseline and on day 21	No
Secondary	metabolomics, isoprostanes (in 24h urine)		at baseline and after 3 weeks	No
Secondary	metabolomics (in 72h feces)		average over 3 days at baseline and after 3 weeks	No
Secondary	blood pressure		at baseline and on day 21	No