AgingNCT02445560
The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function and Wellness in Older Women
A study testing Probiotic capsule and Fiber Sachet in people with Aging, run by University of Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Aging
- What is being tested?
- Probiotic capsule and Fiber Sachet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UF Food Science and Human Nutrition Department
Gainesville, Florida, 32611
UF/IFAS Extension Office Marion County
Ocala, Florida, 34470
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Probiotic capsule and Fiber Sachet, Probiotic capsule and Placebo sachet, Placebo capsule and Fiber Sachet, Placebo capsule and Placebo sachet
- Keywords
- probiotics, prebiotics, high protein diet, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotic capsule and Placebo sachet; Dietary Supplement: Placebo capsule and Fiber Sachet; Dietary 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. Receives: Dietary Supplement: Probiotic capsule and Fiber Sachet; Dietary Supplement: Placebo capsule and Fiber Sachet; Dietary 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. Receives: Dietary Supplement: Probiotic capsule and Fiber Sachet; Dietary Supplement: Probiotic capsule and Placebo sachet; Dietary 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. Receives: Dietary Supplement: Probiotic capsule and Fiber Sachet; Dietary Supplement: Probiotic capsule and Placebo sachet; Dietary Supplement: Placebo capsule and Fiber Sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Change from Baseline at Week 2,4,6,8,10,12,14,16
Secondary outcomes (15)
Digestive Health (Gastrointestinal Symptom Rating Scale )
Measured by gastrointestinal symptoms (gas, bloating, diarrhea, etc.) assessed using the weekly Gastrointestinal Symptom Rating Scale (GSRS).
Measured: 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)
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).
Measured: 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)
Measured by comprehensive Metabolic Panel
Measured: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (lipids)
Measured by Lipid Panel
Measured: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (inflammation)
Measured by Inflammatory markers
Measured: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (blood count)
Measured by Complete Blood Count (CBC)
Measured: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (signalling)
Measured by (mammalian target of rapamycin) mTOR
Measured: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (regulation)
Measured by insulin-like growth factor 1 (IGF-1)
Measured: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (proteolysis)
Measured by total p-cresol
Measured: Change from Baseline at Weeks 2,6,10,14
General Wellness
Individual reporting of antibiotic usage, visits to a physician, etc.
Measured: Day 1 through 126
Proteolytic Activity
Measured by urinary p-cresol, indoxyl sulfate and urine urea nitrogen (UUN)
Measured: Change from Baseline at Weeks 2,6,10,14
Measures of Quality of Life (QoL)
QoL questionnaire (domains such as physical functioning, general health, bodily pain, vitality, social functioning), questionnaire to assess frailty, and hand grip strength
Measured: Change from Baseline at Weeks 2,6,10,14
Measures of Well-being (frailty)
Questionnaire to assess frailty
Measured: Change from Baseline at Weeks 2,6,10,14
Measures of Well-being (hand grip)
Hand grip strength will be measured
Measured: Change from Baseline at Weeks 2,6,10,14
Acceptability of the Diet
Acceptability will be measured using the daily questionnaire and participant compliance recordings/logs of any unconsumed foods during treatment periods
Measured: Day 1 through 126
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Health Solutions
- Responsible party
- Sponsor
- Investigators
- Wendy Dahl, PhD, RD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445560
- Sponsor's protocol ID
- IRB201400955
- Status last verified
- Mar 2018
- First submitted
- 6 Apr 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 32199523
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02445560
- Acronym / sponsor ID
- IRB201400955
- Conditions
- Aging
- Keywords
- probiotics, prebiotics, high protein diet, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Lallemand Health Solutions
- Study start
- Jun 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Probiotic capsule and Fiber sachet | Experimental | Dietary Supplement: Probiotic capsule and Placebo sachet, Dietary Supplement: Placebo capsule and Fiber Sachet, Dietary Supplement: Placebo capsule and Placebo sachetParticipants 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. |
| Probiotic capsule and Placebo sachet | Experimental | Dietary Supplement: Probiotic capsule and Fiber Sachet, Dietary Supplement: Placebo capsule and Fiber Sachet, Dietary Supplement: Placebo capsule and Placebo sachetParticipants 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. |
| Placebo capsule and Fiber sachet | Experimental | Dietary Supplement: Probiotic capsule and Fiber Sachet, Dietary Supplement: Probiotic capsule and Placebo sachet, Dietary Supplement: Placebo capsule and Placebo sachetParticipants 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. |
| Placebo capsule and Placebo sachet | Placebo comparator | Dietary Supplement: Probiotic capsule and Fiber Sachet, Dietary Supplement: Probiotic capsule and Placebo sachet, Dietary Supplement: Placebo capsule and Fiber SachetParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic capsule and Fiber SachetA 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 | Placebo capsule and Fiber sachet, Placebo capsule and Placebo sachet, Probiotic capsule and Placebo sachet |
| Probiotic capsule and Placebo sachetA 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, Placebo capsule and Placebo sachet, Probiotic capsule and Fiber sachet |
| Placebo capsule and Fiber SachetA 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, Probiotic capsule and Fiber sachet, Probiotic capsule and Placebo sachet |
| Placebo capsule and Placebo sachetA 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. | Dietary supplement | Placebo capsule and Fiber sachet, Probiotic capsule and Fiber sachet, Probiotic capsule and Placebo sachet |
Primary outcome
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.
15 secondary outcomes
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
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
Blood Analysis (metabolic)
Time frame: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (lipids)
Time frame: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (inflammation)
Time frame: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (blood count)
Time frame: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (signalling)
Time frame: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (regulation)
Time frame: Change from Baseline at Weeks 2,6,10,14
Blood Analysis (proteolysis)
Time frame: Change from Baseline at Weeks 2,6,10,14
General Wellness
Time frame: Day 1 through 126
Proteolytic Activity
Time frame: Change from Baseline at Weeks 2,6,10,14
Measures of Quality of Life (QoL)
Time frame: Change from Baseline at Weeks 2,6,10,14
Measures of Well-being (frailty)
Time frame: Change from Baseline at Weeks 2,6,10,14
Measures of Well-being (hand grip)
Time frame: Change from Baseline at Weeks 2,6,10,14
Acceptability of the Diet
Time frame: Day 1 through 126
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Derived from this study: PubMed 32199523Ford 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendy Dahl, PhD, RD principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic capsule and Fiber Sachet in people with Aging, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota Studies (recovery) (time frame: Change from Baseline at Week 2,4,6,8,10,12,14,16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02445560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.