- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445560
The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function and Wellness in Older Women
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.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Gainesville, Florida, United States, 32611
- UF Food Science and Human Nutrition Department
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Ocala, Florida, United States, 34470
- UF/IFAS Extension Office Marion County
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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. 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. 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. |
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.
|
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. 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. 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. |
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.
|
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. 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. 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 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.
|
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. 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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Change from Baseline at Week 2,4,6,8,10,12,14,16
|
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.
|
Change from Baseline at Week 2,4,6,8,10,12,14,16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
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
|
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).
|
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
|
Measured by comprehensive Metabolic Panel
|
Change from Baseline at Weeks 2,6,10,14
|
Blood Analysis (lipids)
Time Frame: Change from Baseline at Weeks 2,6,10,14
|
Measured by Lipid Panel
|
Change from Baseline at Weeks 2,6,10,14
|
Blood Analysis (inflammation)
Time Frame: Change from Baseline at Weeks 2,6,10,14
|
Measured by Inflammatory markers
|
Change from Baseline at Weeks 2,6,10,14
|
Blood Analysis (blood count)
Time Frame: Change from Baseline at Weeks 2,6,10,14
|
Measured by Complete Blood Count (CBC)
|
Change from Baseline at Weeks 2,6,10,14
|
Blood Analysis (signalling)
Time Frame: Change from Baseline at Weeks 2,6,10,14
|
Measured by (mammalian target of rapamycin) mTOR
|
Change from Baseline at Weeks 2,6,10,14
|
Blood Analysis (regulation)
Time Frame: Change from Baseline at Weeks 2,6,10,14
|
Measured by insulin-like growth factor 1 (IGF-1)
|
Change from Baseline at Weeks 2,6,10,14
|
Blood Analysis (proteolysis)
Time Frame: Change from Baseline at Weeks 2,6,10,14
|
Measured by total p-cresol
|
Change from Baseline at Weeks 2,6,10,14
|
General Wellness
Time Frame: Day 1 through 126
|
Individual reporting of antibiotic usage, visits to a physician, etc.
|
Day 1 through 126
|
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)
|
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
|
QoL questionnaire (domains such as physical functioning, general health, bodily pain, vitality, social functioning), questionnaire to assess frailty, and hand grip strength
|
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
|
Questionnaire to assess frailty
|
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
|
Hand grip strength will be measured
|
Change from Baseline at Weeks 2,6,10,14
|
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
|
Day 1 through 126
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendy Dahl, PhD, RD, University of Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB201400955
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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