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The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function and Wellness in Older Women

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ClinicalTrials.gov Identifier: NCT02445560
Recruitment Status : Completed
First Posted : May 15, 2015
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Lallemand Health Solutions
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE April 6, 2015
First Posted Date  ICMJE May 15, 2015
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • Microbiota Studies (recovery) [ Time Frame: Change from Baseline at Week 2,4,6,8,10,12,14,16 ]
    Change in the concentrations of the probiotic strains in the stools will be measured with strain specific deoxyribonucleic acid (DNA) (or antibodies) in fecal samples (e.g. quantitative polymerase chain reaction (qPCR), flow cytometry).
  • Microbiota Studies (overall composition) [ Time Frame: Change from Baseline at Week 2,4,6,8,10,12,14,16 ]
    Effects of the probiotic interventions on overall microbiota composition (e.g. 454 16S rRNA (ribosomal ribonucleic acid) sequencing) will also be measured.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • Digestive Health (Gastrointestinal Symptom Rating Scale ) [ Time Frame: Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 ]
    Measured by gastrointestinal symptoms (gas, bloating, diarrhea, etc.) assessed using the weekly Gastrointestinal Symptom Rating Scale (GSRS).
  • Digestive Health (Bristol Stool Scale) [ Time Frame: Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18 ]
    Measured by gastrointestinal symptoms (gas, bloating, diarrhea, etc.) assessed using a daily questionnaire. The daily questionnaire will include questions regarding symptoms and the Bristol Stool Scale (stool form and transit).
  • Blood Analysis (metabolic) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by comprehensive Metabolic Panel
  • Blood Analysis (lipids) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by Lipid Panel
  • Blood Analysis (inflammation) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by Inflammatory markers
  • Blood Analysis (blood count) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by Complete Blood Count (CBC)
  • Blood Analysis (signalling) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by (mammalian target of rapamycin) mTOR
  • Blood Analysis (regulation) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by insulin-like growth factor 1 (IGF-1)
  • Blood Analysis (proteolysis) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by total p-cresol
  • General Wellness [ Time Frame: Day 1 through 126 ]
    Individual reporting of antibiotic usage, visits to a physician, etc.
  • Proteolytic Activity [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Measured by urinary p-cresol, indoxyl sulfate and urine urea nitrogen (UUN)
  • Measures of Quality of Life (QoL) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    QoL questionnaire (domains such as physical functioning, general health, bodily pain, vitality, social functioning), questionnaire to assess frailty, and hand grip strength
  • Measures of Well-being (frailty) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Questionnaire to assess frailty
  • Measures of Well-being (hand grip) [ Time Frame: Change from Baseline at Weeks 2,6,10,14 ]
    Hand grip strength will be measured
  • Acceptability of the Diet [ Time Frame: Day 1 through 126 ]
    Acceptability will be measured using the daily questionnaire and participant compliance recordings/logs of any unconsumed foods during treatment periods
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function and Wellness in Older Women
Official Title  ICMJE The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function, Wellness and the Potential Mitigating Effects of a Multi-strain Probiotic, Prebiotic, and Synbiotic: a Randomized, Double-blinded Crossover Study in Older Women.
Brief Summary The purpose of the proposed study is to determine the effects of consuming a high protein diet on fecal microbial communities, gastrointestinal function and symptoms, and general wellness in older adults.
Detailed Description

Older women will be randomized to a 18-week crossover study design. During each treatment period participants will be provided with a weight maintenance diet providing approximately 2 g/kg/day of protein.

Following a two-week baseline and in random order will have the following diets assigned:

The participants will be provided with a weight maintenance, high protein diet for two weeks, then for two-weeks will resume their normal diet;

The participants will come back into clinic and for the next two weeks to receive a high protein diet with a multi-strain probiotic for two weeks, then for two-weeks will resume their normal diet;

The participants will come back into clinic and for the next two weeks will receive a high protein diet with a prebiotic, then for two-weeks will resume their normal diet;

The participants will come back into clinic and for the next two weeks will receive a high protein diet with the synbiotic combination. then for two-weeks will resume their normal diet

Participants and researchers will be blinded for each treatment period (participants will receive a probiotic or placebo capsule, and a prebiotic or placebo sachet).

The following will be performed during the clinic visits: Questionnaires will assess quality of life (QoL), wellness, gastrointestinal symptoms, bowel movement frequency, and compliance. Hand-grip strength will be measured. Blood and urine samples will be collected at baseline and at weeks 2, 6,10 and 14. Stool samples will be collected at baseline and at weeks 2, 4, 6, 8,10, 12, 14 and 16.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Aging
Intervention  ICMJE
  • Dietary Supplement: Probiotic capsule and Fiber Sachet

    A probiotic capsule and fiber sachet will be consumed daily for 2-weeks. The probiotic capsule contains a mixture of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus acidophilus and Lactobacillus plantarum. The fiber sachet consists of 5 g of chicory root fiber.

    During the treatment period, in addition to consuming the probiotic capsule and fiber sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein.

  • Dietary Supplement: Probiotic capsule and Placebo sachet

    A probiotic capsule and placebo sachet will be consumed daily for 2-weeks. The probiotic capsule contains a mixture of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus acidophilus and Lactobacillus plantarum. The placebo sachet consists of 5 g of maltodextrin.

    During the treatment period, in addition to consuming the probiotic capsule and placebo sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein.

  • Dietary Supplement: Placebo capsule and Fiber Sachet

    A placebo capsule and fiber sachet will be consumed daily for 2-weeks. The placebo capsule will contain potato starch, magnesium stearate and ascorbic acid. The fiber sachet consists of 5 g of chicory root fiber.

    During the treatment period, in addition to consuming the placebo capsule and fiber sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein.

  • Dietary Supplement: Placebo capsule and Placebo sachet

    A placebo capsule and placebo sachet will be consumed daily for 2-weeks. The placebo capsule will contain potato starch, magnesium stearate and ascorbic acid. The fiber sachet consists of 5 g of maltodextrin.

    During the treatment period, in addition to consuming the placebo capsule and placebo sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein.

Study Arms  ICMJE
  • Experimental: Probiotic capsule and Fiber sachet
    Participants will be randomly assigned to receive all of the following in random order: a probiotic capsule and fiber sachet daily for 2-weeks, a probiotic capsule and placebo sachet for 2-weeks, a fiber sachet and placebo capsule for 2-weeks, and placebo capsule and placebo sachet for 2-weeks. Each treatment period is separated by a 2-week washout. During each treatment period, in addition to consuming a probiotic capsule or placebo and/or a fiber sachet or placebo sachet participants will be on a controlled higher protein diet.
    Interventions:
    • Dietary Supplement: Probiotic capsule and Placebo sachet
    • Dietary Supplement: Placebo capsule and Fiber Sachet
    • Dietary Supplement: Placebo capsule and Placebo sachet
  • Experimental: Probiotic capsule and Placebo sachet
    Participants will be randomly assigned to receive all of the following in random order: a probiotic capsule and fiber sachet daily for 2-weeks, a probiotic capsule and placebo sachet for 2-weeks, a fiber sachet and placebo capsule for 2-weeks, and placebo capsule and placebo sachet for 2-weeks. Each treatment period is separated by a 2-week washout. During each treatment period, in addition to consuming a probiotic capsule or placebo and/or a fiber sachet or placebo sachet participants will be on a controlled higher protein diet.
    Interventions:
    • Dietary Supplement: Probiotic capsule and Fiber Sachet
    • Dietary Supplement: Placebo capsule and Fiber Sachet
    • Dietary Supplement: Placebo capsule and Placebo sachet
  • Experimental: Placebo capsule and Fiber sachet
    Participants will be randomly assigned to receive all of the following in random order: a probiotic capsule and fiber sachet daily for 2-weeks, a probiotic capsule and placebo sachet for 2-weeks, a fiber sachet and placebo capsule for 2-weeks, and placebo capsule and placebo sachet for 2-weeks. Each treatment period is separated by a 2-week washout. During each treatment period, in addition to consuming a probiotic capsule or placebo and/or a fiber sachet or placebo sachet participants will be on a controlled higher protein diet.
    Interventions:
    • Dietary Supplement: Probiotic capsule and Fiber Sachet
    • Dietary Supplement: Probiotic capsule and Placebo sachet
    • Dietary Supplement: Placebo capsule and Placebo sachet
  • Placebo Comparator: Placebo capsule and Placebo sachet
    Participants will be randomly assigned to receive all of the following in random order: a probiotic capsule and fiber sachet daily for 2-weeks, a probiotic capsule and placebo sachet for 2-weeks, a fiber sachet and placebo capsule for 2-weeks, and placebo capsule and placebo sachet for 2-weeks. Each treatment period is separated by a 2-week washout. During each treatment period, in addition to consuming a probiotic capsule or placebo and/or a fiber sachet or placebo sachet participants will be on a controlled higher protein diet.
    Interventions:
    • Dietary Supplement: Probiotic capsule and Fiber Sachet
    • Dietary Supplement: Probiotic capsule and Placebo sachet
    • Dietary Supplement: Placebo capsule and Fiber Sachet
Publications * Ford AL, Nagulesapillai V, Piano A, Auger J, Girard SA, Christman M, Tompkins TA, Dahl WJ. Microbiota Stability and Gastrointestinal Tolerance in Response to a High-Protein Diet with and without a Prebiotic, Probiotic, and Synbiotic: A Randomized, Double-Blind, Placebo-Controlled Trial in Older Women. J Acad Nutr Diet. 2020 Apr;120(4):500-516.e10. doi: 10.1016/j.jand.2019.12.009.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
29
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2015)
25
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To participate in the study you must

  • be a woman 65 years of age or older
  • be willing to complete daily and weekly questionnaires
  • be willing to wear a SenseWear Pro Armband (BodyMedia, Inc.) to monitor energy expenditure and establish dietary energy needs
  • be willing to provide blood samples, stool samples, and urine samples throughout the course of the study
  • be willing to discontinue prebiotics, probiotics and/or any fiber supplements for the duration of the study
  • be willing to consume the provided diet for the designated 8 weeks of the study
  • are willing to report and maintain their usual alcohol intake throughout the study
  • are able to take foods, study fiber, probiotic, and placebo without the aid of another person
  • able to attend all scheduled study appointments for the duration of the study
  • have a usual protein intake consistent with United States' population as assessed by dietary analysis
  • have a usual fiber intake consistent with United States' population as assessed by dietary analysis
  • be willing to provide a social security number to receive study payment.

Exclusion Criteria:

To participate in the study you must NOT

  • have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiac disease, short bowel disease, ileostomy)
  • have had or are currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes or chronic kidney disease
  • be a vegetarian
  • have any known food allergies or dietary restrictions
  • be currently taking medication for constipation or diarrhea
  • have taken antibiotics within the past 2 months
  • be a current smoker
  • be planning on loosing/gaining weight during the next 6 months
  • typically consume no more than one alcoholic beverage per day
  • have a BMI greater than 30
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02445560
Other Study ID Numbers  ICMJE IRB201400955
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Lallemand Health Solutions
Investigators  ICMJE
Principal Investigator: Wendy Dahl, PhD, RD University of Florida
PRS Account University of Florida
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP