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

NCT01317264 | Completed

• 1 other identifier: M196
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

β-glucan; cholesterol; bile acids; blood glucose; appetite

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

Study Arms (4)

Placebo milk drink

PLACEBO COMPARATOR

Other: no β-glucan

Millk drink with oat β-glucan

EXPERIMENTAL

Other: oat β-glucan

Milk drink with barley β-glucan

EXPERIMENTAL

Other: barley β-glucan

Milk drink with mutant-barley β-glucan

EXPERIMENTAL

Other: mutant-barley β-glucan

Interventions

no β-glucan OTHER

daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days

Placebo milk drink

oat β-glucan OTHER

daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days

Also known as: "PromOat",Biovelop, Kimstad, Sweden

Millk drink with oat β-glucan

barley β-glucan OTHER

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

Milk drink with barley β-glucan

mutant-barley β-glucan OTHER

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

Milk drink with mutant-barley β-glucan

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• normal weight or moderately overweight (BMI 18.5-30 kg/m²)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 1165, Denmark

Location

Study Officials

• Arne Astrup, Professor

  Department of human nutrition, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 17, 2011
• Study Start: November 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 17, 2011

Record last verified: 2009-11

Locations

DK (1)