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

Not Applicable

Completed

• Conditions: Aging
• Interventions: Dietary Supplement: Probiotic capsule and Placebo sachet; Dietary Supplement: Probiotic capsule and Fiber Sachet; Dietary Supplement: Placebo capsule and Fiber Sachet; Dietary Supplement: Placebo capsule and Placebo sachet

• Registration Number: NCT02445560
• Lead Sponsor: University of Florida

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 Timeline

• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Study Start: 2015-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Probiotic capsule and Fiber sachet	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.
Probiotic capsule and Fiber sachet	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.
Placebo capsule and Fiber sachet	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.
Placebo capsule and Placebo sachet	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.
Probiotic capsule and Fiber sachet	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.
Probiotic capsule and Placebo sachet	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.
Probiotic capsule and Placebo sachet	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.
Placebo capsule and Fiber sachet	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.
Placebo capsule and Placebo sachet	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.
Probiotic capsule and Placebo sachet	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.
Placebo capsule and Fiber sachet	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.
Placebo capsule and Placebo sachet	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.

Primary Outcome Measures

Name	Time	Method
Microbiota Studies (overall composition)	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)	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 Outcome Measures

Name	Time	Method
Blood Analysis (metabolic)	Change from Baseline at Weeks 2,6,10,14	Measured by comprehensive Metabolic Panel
Blood Analysis (regulation)	Change from Baseline at Weeks 2,6,10,14	Measured by insulin-like growth factor 1 (IGF-1)
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	Measured by gastrointestinal symptoms (gas, bloating, diarrhea, etc.) assessed using the weekly Gastrointestinal Symptom Rating Scale (GSRS).
Blood Analysis (blood count)	Change from Baseline at Weeks 2,6,10,14	Measured by Complete Blood Count (CBC)
Blood Analysis (proteolysis)	Change from Baseline at Weeks 2,6,10,14	Measured by total p-cresol
Blood Analysis (lipids)	Change from Baseline at Weeks 2,6,10,14	Measured by Lipid Panel
Blood Analysis (inflammation)	Change from Baseline at Weeks 2,6,10,14	Measured by Inflammatory markers
Blood Analysis (signalling)	Change from Baseline at Weeks 2,6,10,14	Measured by (mammalian target of rapamycin) mTOR
Measures of Quality of Life (QoL)	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
Acceptability of the Diet	Day 1 through 126	Acceptability will be measured using the daily questionnaire and participant compliance recordings/logs of any unconsumed foods during treatment periods
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	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).
Proteolytic Activity	Change from Baseline at Weeks 2,6,10,14	Measured by urinary p-cresol, indoxyl sulfate and urine urea nitrogen (UUN)
General Wellness	Day 1 through 126	Individual reporting of antibiotic usage, visits to a physician, etc.
Measures of Well-being (frailty)	Change from Baseline at Weeks 2,6,10,14	Questionnaire to assess frailty
Measures of Well-being (hand grip)	Change from Baseline at Weeks 2,6,10,14	Hand grip strength will be measured

Trial Locations

Locations (2)

UF Food Science and Human Nutrition Department; 🇺🇸 Gainesville, Florida, United States

UF/IFAS Extension Office Marion County; 🇺🇸 Ocala, Florida, United States