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

Aging Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02445560
• Other study ID #: IRB201400955
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: March 28, 2018
• Start date: June 2015
• Est. completion date: October 2015

Study information

• Verified date: March 2018
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Probiotic capsule and Fiber Sachet
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 sachet
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 Sachet
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 sachet
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.

Locations

Country	Name	City	State
United States	UF Food Science and Human Nutrition Department	Gainesville	Florida
United States	UF/IFAS Extension Office Marion County	Ocala	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Lallemand Health Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Digestive Health (Gastrointestinal Symptom Rating Scale )	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
Secondary	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).	Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18
Secondary	Blood Analysis (metabolic)	Measured by comprehensive Metabolic Panel	Change from Baseline at Weeks 2,6,10,14
Secondary	Blood Analysis (lipids)	Measured by Lipid Panel	Change from Baseline at Weeks 2,6,10,14
Secondary	Blood Analysis (inflammation)	Measured by Inflammatory markers	Change from Baseline at Weeks 2,6,10,14
Secondary	Blood Analysis (blood count)	Measured by Complete Blood Count (CBC)	Change from Baseline at Weeks 2,6,10,14
Secondary	Blood Analysis (signalling)	Measured by (mammalian target of rapamycin) mTOR	Change from Baseline at Weeks 2,6,10,14
Secondary	Blood Analysis (regulation)	Measured by insulin-like growth factor 1 (IGF-1)	Change from Baseline at Weeks 2,6,10,14
Secondary	Blood Analysis (proteolysis)	Measured by total p-cresol	Change from Baseline at Weeks 2,6,10,14
Secondary	General Wellness	Individual reporting of antibiotic usage, visits to a physician, etc.	Day 1 through 126
Secondary	Proteolytic Activity	Measured by urinary p-cresol, indoxyl sulfate and urine urea nitrogen (UUN)	Change from Baseline at Weeks 2,6,10,14
Secondary	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	Change from Baseline at Weeks 2,6,10,14
Secondary	Measures of Well-being (frailty)	Questionnaire to assess frailty	Change from Baseline at Weeks 2,6,10,14
Secondary	Measures of Well-being (hand grip)	Hand grip strength will be measured	Change from Baseline at Weeks 2,6,10,14
Secondary	Acceptability of the Diet	Acceptability will be measured using the daily questionnaire and participant compliance recordings/logs of any unconsumed foods during treatment periods	Day 1 through 126