The Effect of Altering Colonic Microflora After Fiber (FOS) Consumption

NCT00516594 | Completed Phase 2

• 1 other identifier: REB 205UC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Our antibiotic studies indicated that cholesterol lowering was seen when fecal bifidobacterial counts were increased. Due to the dangers associated with prolonged antibiotic use we have been funded by the Heart and Stroke Foundation to see if gut bacteria can be modified by non-antibiotic means. Inulin a dietary fiber found in artichokes, chicory, leaks, onion, etc., (which also produces flatulence) has been shown to increase bifidobacteria and also appears to lower serum cholesterol. We will therefore test the fiber to determine its effectiveness in lowering serum cholesterol and whether it can be used to maximize the cholesterol-lowering effects of soy protein foods and viscous fiber foods (e.g. oats and psyllium).

Conditions

Hyperlipidemia; Cardiovascular Disease; Diet Therapy

Outcome Measures

Primary Outcomes (1)

• Total and LDL cholesterol, Total:HDl cholesterol ratio

Secondary Outcomes (1)

• antropometrics: body weight, blood pressure, blood: triglycerides, fecal: SCFA and microbiology, breath: gases, urine: soy isoflavones, creatinine, urea, electrolytes

Interventions

Diet with polyfructans and viscous fibers or soy protein PROCEDURE

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LDL-C \> 4.1 mmol/L at recruitment
• living within a 40 km radius of St. Michael's Hospital

You may not qualify if:

• lipid lowering medications
• clinical or biochemical evidence of diabetes, renal or hepatic disease
• body mass index (BMI) \>32 kg/m2
• antibiotic use within the last three months
• hormone replacement therapy
• smoking or significant alcohol intake (\>1 drink/d)
• triglyceride level \>4.0 mmol/L

Sponsors & Collaborators

• University of Toronto: lead
• Heart and Stroke Foundation of Ontario: collaborator
• Orafti Group: collaborator

Study Sites (1)

Clinical Nutrition & Risk Factor Modification Centre, St. Michael's Health Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Related Publications (1)

• Wong JM, Kendall CW, Marchie A, Liu Z, Vidgen E, Holmes C, Jackson CJ, Josse RG, Pencharz PB, Rao AV, Vuksan V, Singer W, Jenkins DJ. Equol status and blood lipid profile in hyperlipidemia after consumption of diets containing soy foods. Am J Clin Nutr. 2012 Mar;95(3):564-71. doi: 10.3945/ajcn.111.017418. Epub 2012 Feb 1.

  PMID: 22301925 DERIVED

MeSH Terms

Conditions

Hyperlipidemias; Cardiovascular Diseases

Interventions

Diet; Soybean Proteins

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• David JA Jenkins, MD, PHD, DSc

  University of Toronto and St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 13, 2007
• First Posted: August 15, 2007
• Last Updated: January 21, 2009

Record last verified: 2009-01

Locations

CA (1)