NCT01814540

Brief Summary

The purpose of this study is to elucidate tolerability and effectiveness in consumption of the complex indigestible sugars from dairy products called bovine milk oligosaccharides (BMO) to enrich intestinal microflora toward beneficial populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2013

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

March 13, 2013

Last Update Submit

September 27, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Gut microbiota

    Gut microbiota will be analyzed for 16s rRNA by next generation sequencing, terminal restriction fragment length polymorphism, and quantitative polymerase chain reaction.

    Change from baseline to day 11

Secondary Outcomes (8)

  • Urinary Metabolites

    Days 0, 4, 11

  • Plasma Lipid Profile

    Day 0 and Day 11

  • Plasma Glucose

    Day 0 and Day 11

  • Dietary Macronutrient Intake

    Day 0

  • Gut Tolerability

    Days Minus 7 and Days 0-10

  • +3 more secondary outcomes

Study Arms (3)

Placebo Control, Glucose polymer

PLACEBO COMPARATOR

Treatment 1: Polycose Glucose Polymer Module powder (Abbott Nutrition, Abbott Park, Illinois 60064), fed as 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days.

Dietary Supplement: Placebo Glucose Polymer

Treatment 2: Low-Dose BMO

EXPERIMENTAL

Treatment 2: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 25% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period Fiber intake was 25% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days.

Dietary Supplement: Bovine Milk Oligosaccharide

Treatment 3: High-Dose BMO

EXPERIMENTAL

Treatment 3: Bovine Milk Oligosaccharide (BMO) powder (Hilmar Ingredients, Hilmar, California 95324) Dosage: 35% of individual daily fiber intake, split into two daily servings Frequency: Two servings per day (for total of 25% dosage per day) Duration: 11 days, followed by a 2-week wash-out period Fiber intake was 35% of each individual's daily fiber intake based on calculated energy expenditure (14 grams of fiber for every 1000 kcal consumed) for eleven consecutive days.

Dietary Supplement: Bovine Milk Oligosaccharide

Interventions

Bovine Milk OligosaccharideDIETARY_SUPPLEMENT

The BMO powder will be isolated from whey streams by Hilmar Ingredients (Hilmar, California 95324). Hilmar Ingredients employs the same membrane filtration, and centrifugation processes used to purify whey protein in their commercial practice to extract and purify BMO from whey permeate. Furthermore, the same sterilization processes used on the equipment to purify whey products will be used to purify BMO. This method uses a novel high-throughput food-grade isolation protocol that leads to purification of specific BMOs with bifidogenic activity as prebiotic oligosaccharides that mimic the activities observed for Human Milk Oligosaccharides (HMO). This strategy of developing methods for their large scale fractionation allows us to obtain a final product that mimics the naturally beneficial oligosaccharides present in human milk.

Treatment 2: Low-Dose BMOTreatment 3: High-Dose BMO
Placebo Glucose PolymerDIETARY_SUPPLEMENT
Placebo Control, Glucose polymer

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women aged 18-40 years old
  • BMI 18-25
  • Born by vaginal birth (not C-section)
  • Breastfed for a minimum of 2 months after birth

You may not qualify if:

  • Individuals who regularly consume high fiber cereals or fiber supplements
  • Individuals who frequently consume yogurt (eligible if willing to refrain consumption during the study period)
  • Individuals who are lactose intolerant and/or allergic to dairy or wheat
  • Individuals who use tobacco products
  • Individuals who are pregnant or lactating
  • Individuals with a known presence of gastrointestinal/malabsorption disorders or autoimmune disease
  • Individuals taking prescription or over-the-counter medications that include pre/probiotics, corticosteroids, anti-obesity agents, laxatives, and lipid- altering medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis

Davis, California, 95616, United States

Location

Related Publications (12)

  • Pedersen A, Sandstrom B, Van Amelsvoort JM. The effect of ingestion of inulin on blood lipids and gastrointestinal symptoms in healthy females. Br J Nutr. 1997 Aug;78(2):215-22. doi: 10.1079/bjn19970141.

    PMID: 9301412BACKGROUND

  • Tao N, DePeters EJ, Freeman S, German JB, Grimm R, Lebrilla CB. Bovine milk glycome. J Dairy Sci. 2008 Oct;91(10):3768-78. doi: 10.3168/jds.2008-1305.

    PMID: 18832198BACKGROUND

  • Tao N, DePeters EJ, German JB, Grimm R, Lebrilla CB. Variations in bovine milk oligosaccharides during early and middle lactation stages analyzed by high-performance liquid chromatography-chip/mass spectrometry. J Dairy Sci. 2009 Jul;92(7):2991-3001. doi: 10.3168/jds.2008-1642.

    PMID: 19528576BACKGROUND

  • Barile D, Tao N, Lebrilla CB, Coisson JD, Arlorio M, German JB. Permeate from cheese whey ultrafiltration is a source of milk oligosaccharides. Int Dairy J. 2009 Sep 1;19(9):524-530. doi: 10.1016/j.idairyj.2009.03.008.

    PMID: 20161544BACKGROUND

  • Barile D, Marotta M, Chu C, Mehra R, Grimm R, Lebrilla CB, German JB. Neutral and acidic oligosaccharides in Holstein-Friesian colostrum during the first 3 days of lactation measured by high performance liquid chromatography on a microfluidic chip and time-of-flight mass spectrometry. J Dairy Sci. 2010 Sep;93(9):3940-9. doi: 10.3168/jds.2010-3156.

    PMID: 20723667BACKGROUND

  • Strum JS, Aldredge D, Barile D, Lebrilla CB. Coupling flash liquid chromatography with mass spectrometry for enrichment and isolation of milk oligosaccharides for functional studies. Anal Biochem. 2012 May 15;424(2):87-96. doi: 10.1016/j.ab.2012.02.012. Epub 2012 Feb 25.

    PMID: 22370281BACKGROUND

  • Sundekilde UK, Barile D, Meyrand M, Poulsen NA, Larsen LB, Lebrilla CB, German JB, Bertram HC. Natural variability in bovine milk oligosaccharides from Danish Jersey and Holstein-Friesian breeds. J Agric Food Chem. 2012 Jun 20;60(24):6188-96. doi: 10.1021/jf300015j. Epub 2012 Jun 6.

    PMID: 22632419BACKGROUND

  • Zivkovic AM, Barile D. Bovine milk as a source of functional oligosaccharides for improving human health. Adv Nutr. 2011 May;2(3):284-9. doi: 10.3945/an.111.000455. Epub 2011 Apr 30.

    PMID: 22332060BACKGROUND

  • Garrido D, Barile D, Mills DA. A molecular basis for bifidobacterial enrichment in the infant gastrointestinal tract. Adv Nutr. 2012 May 1;3(3):415S-21S. doi: 10.3945/an.111.001586.

    PMID: 22585920BACKGROUND

  • Aldredge DL, Geronimo MR, Hua S, Nwosu CC, Lebrilla CB, Barile D. Annotation and structural elucidation of bovine milk oligosaccharides and determination of novel fucosylated structures. Glycobiology. 2013 Jun;23(6):664-76. doi: 10.1093/glycob/cwt007. Epub 2013 Feb 22.

    PMID: 23436288BACKGROUND

  • Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

    PMID: 9299672BACKGROUND

  • Smilowitz JT, Lemay DG, Kalanetra KM, Chin EL, Zivkovic AM, Breck MA, German JB, Mills DA, Slupsky C, Barile D. Tolerability and safety of the intake of bovine milk oligosaccharides extracted from cheese whey in healthy human adults. J Nutr Sci. 2017 Feb 20;6:e6. doi: 10.1017/jns.2017.2. eCollection 2017.

    PMID: 28620481RESULT

Related Links

Study Officials

  • Daniela Barile, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Jennifer Smilowitz, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • J. Bruce German, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Carolyn Slupsky, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Angela M Zivkovic, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • David A Mills, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 20, 2013

Study Start

August 1, 2012

Primary Completion

November 16, 2012

Study Completion

January 22, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)