NCT02445560

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 6, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

April 6, 2015

Last Update Submit

March 28, 2018

Conditions

Aging

Keywords

probioticsprebioticshigh protein dietmicrobiota

Outcome Measures

Primary Outcomes (2)

  • Microbiota Studies (recovery)

    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).

    Change from Baseline at Week 2,4,6,8,10,12,14,16

  • Microbiota Studies (overall composition)

    Effects of the probiotic interventions on overall microbiota composition (e.g. 454 16S rRNA (ribosomal ribonucleic acid) sequencing) will also be measured.

    Change from Baseline at Week 2,4,6,8,10,12,14,16

Secondary Outcomes (15)

  • Digestive Health (Gastrointestinal Symptom Rating Scale )

    Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18

  • Digestive Health (Bristol Stool Scale)

    Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18

  • Blood Analysis (metabolic)

    Change from Baseline at Weeks 2,6,10,14

  • Blood Analysis (lipids)

    Change from Baseline at Weeks 2,6,10,14

  • Blood Analysis (inflammation)

    Change from Baseline at Weeks 2,6,10,14

  • +10 more secondary outcomes

Study Arms (4)

Probiotic capsule and Fiber sachet

EXPERIMENTAL

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.

Dietary Supplement: Probiotic capsule and Placebo sachetDietary Supplement: Placebo capsule and Fiber SachetDietary Supplement: Placebo capsule and Placebo sachet

Probiotic capsule and Placebo sachet

EXPERIMENTAL

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.

Dietary Supplement: Probiotic capsule and Fiber SachetDietary Supplement: Placebo capsule and Fiber SachetDietary Supplement: Placebo capsule and Placebo sachet

Placebo capsule and Fiber sachet

EXPERIMENTAL

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.

Dietary Supplement: Probiotic capsule and Fiber SachetDietary Supplement: Probiotic capsule and Placebo sachetDietary Supplement: Placebo capsule and Placebo sachet

Placebo capsule and Placebo sachet

PLACEBO COMPARATOR

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.

Dietary Supplement: Probiotic capsule and Fiber SachetDietary Supplement: Probiotic capsule and Placebo sachetDietary Supplement: Placebo capsule and Fiber Sachet

Interventions

Probiotic capsule and Fiber SachetDIETARY_SUPPLEMENT

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.

Placebo capsule and Fiber sachetPlacebo capsule and Placebo sachetProbiotic capsule and Placebo sachet
Probiotic capsule and Placebo sachetDIETARY_SUPPLEMENT

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.

Placebo capsule and Fiber sachetPlacebo capsule and Placebo sachetProbiotic capsule and Fiber sachet
Placebo capsule and Fiber SachetDIETARY_SUPPLEMENT

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.

Placebo capsule and Placebo sachetProbiotic capsule and Fiber sachetProbiotic capsule and Placebo sachet
Placebo capsule and Placebo sachetDIETARY_SUPPLEMENT

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.

Placebo capsule and Fiber sachetProbiotic capsule and Fiber sachetProbiotic capsule and Placebo sachet

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UF Food Science and Human Nutrition Department

Gainesville, Florida, 32611, United States

Location

UF/IFAS Extension Office Marion County

Ocala, Florida, 34470, United States

Location

Related Publications (1)

  • 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.

    PMID: 32199523DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Wendy Dahl, PhD, RD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

May 15, 2015

Study Start

June 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

US(2)