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Completed

NCT Number: NCT01073969

Study to Determine the Digestive and Physiological Effects of an Extract From Bran in Healthy Men and Women

The primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Provident CRC

Glen Ellyn, Illinois, 60137, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • 18-75 years of age
  • Body mass index ≥18.5 and <35.0 kg/m2
  • Fasting LDL-C level ≥100 mg/dL and <200 mg/dL
  • Otherwise judged to be in good health, willing to maintain habitual food and beverage intake and physical activity patterns throughout the trial

Exclusion criteria

  • Significant gastrointestinal condition
  • Use of pre/probiotic foods or supplements
  • Use of antibiotics
  • Pregnancy
  • Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
  • Poorly controlled hypertension
  • Cancer treated within prior 2 years

Treatment and study plan

wheat bran extract

Other

Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract

Other names: wheat bran oligosccharides, prebiotic oligosccharides

control wheat bran extract

Other

Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract

Other names: wheat bran oligosccharides, prebiotic oligosccharides

Primary outcomes

  1. The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight)

    Time frame: Baseline to end of each treatment (week 0 to week 3 of each treatment)

Secondary outcomes

  1. Other fecal bacterial counts

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  2. laxation

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  3. fecal pH

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  4. fecal moisture

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  5. stool consistency

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  6. blood glucose

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  7. Blood insulin

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  8. plasma lipid profiles

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  9. serum free fatty acids

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  10. fecal short chain fatty acids

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  11. fecal ammonia

    Time frame: baseline to end of each treament (week 0 to week 3 of each treatment)

  12. urinary para-cresol

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  13. urinary phenol (total)

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  14. urinary isoprostanes

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  15. oxidized low density lipoprotein (TBARS, conjugated dienes)

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  16. Urinary F2alpha-isoprostanes

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  17. Plasma antioxidant capacity (ORAC, FRAP)

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  18. serum amyloid A

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  19. hs-CRP

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  20. IL-6

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  21. TNF-alpha

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  22. gastrointestinal symptom survey

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  23. stool consistency (Bristol stool scale)

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

  24. Quality of Life questionaire (Quality Metrics SF-36)

    Time frame: baseline to end of each treatment (week 0 to week 3 of each treatment)

Sponsors and collaborators

Lead sponsor

Kellogg Company

Industry

Collaborators

  • Provident Clinical Research
  • Tufts University
  • University of Reading
  • University of Saskatchewan
  • University of Toronto

Registry information

Official study title

A Double-blind, Randomized, Controlled Crossover Trial to Assess the Digestive and Physiological Effects of a Wheat Bran Extract in Healthy Men and Women

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 23, 2010
Registry last updated
Feb 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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