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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 29
- Locations
- 2
- Primary Endpoint
- Microbiota Studies (overall composition)
Study Overview
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;
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Probiotic capsule and Placebo sachet (Dietary Supplement)
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.
Intervention: Placebo capsule and Fiber Sachet (Dietary Supplement)
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.
Intervention: Placebo capsule and Placebo sachet (Dietary Supplement)
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.
Intervention: Probiotic capsule and Fiber Sachet (Dietary Supplement)
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.
Intervention: Placebo capsule and Fiber Sachet (Dietary Supplement)
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.
Intervention: Placebo capsule and Placebo sachet (Dietary Supplement)
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.
Intervention: Probiotic capsule and Fiber Sachet (Dietary Supplement)
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.
Intervention: Probiotic capsule and Placebo sachet (Dietary Supplement)
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.
Intervention: Placebo capsule and Placebo sachet (Dietary Supplement)
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.
Intervention: Probiotic capsule and Fiber Sachet (Dietary Supplement)
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.
Intervention: Probiotic capsule and Placebo sachet (Dietary Supplement)
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.
Intervention: Placebo capsule and Fiber Sachet (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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).
Secondary Outcomes
- 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)
- Proteolytic Activity(Change from Baseline at Weeks 2,6,10,14)
- Blood Analysis (metabolic)(Change from Baseline at Weeks 2,6,10,14)
- Blood Analysis (regulation)(Change from Baseline at Weeks 2,6,10,14)
- 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)
- Blood Analysis (blood count)(Change from Baseline at Weeks 2,6,10,14)
- Blood Analysis (proteolysis)(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)
- Blood Analysis (signalling)(Change from Baseline at Weeks 2,6,10,14)
- Measures of Quality of Life (QoL)(Change from Baseline at Weeks 2,6,10,14)
- Acceptability of the Diet(Day 1 through 126)
- General Wellness(Day 1 through 126)
- Measures of Well-being (frailty)(Change from Baseline at Weeks 2,6,10,14)
- Measures of Well-being (hand grip)(Change from Baseline at Weeks 2,6,10,14)