Clinical trial NCT02445560: The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function and Wellness in Older Women
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: probiotics
prebiotics
high protein diet
microbiota
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Lallemand Health Solutions
First posted: 2015-05-15
Enrollment: 29
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Microbiota Studies (recovery)
timeFrame: Change from Baseline at Week 2,4,6,8,10,12,14,16
measure: Microbiota Studies (overall composition)
timeFrame: Change from Baseline at Week 2,4,6,8,10,12,14,16
Secondary outcomes:
measure: Digestive Health (Gastrointestinal Symptom Rating Scale )
timeFrame: Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18
measure: Digestive Health (Bristol Stool Scale)
timeFrame: Change from Baseline at Week 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18
measure: Blood Analysis (metabolic)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Blood Analysis (lipids)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Blood Analysis (inflammation)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Blood Analysis (blood count)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Blood Analysis (signalling)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Blood Analysis (regulation)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Blood Analysis (proteolysis)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: General Wellness
timeFrame: Day 1 through 126
measure: Proteolytic Activity
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Measures of Quality of Life (QoL)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Measures of Well-being (frailty)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Measures of Well-being (hand grip)
timeFrame: Change from Baseline at Weeks 2,6,10,14
measure: Acceptability of the Diet
timeFrame: Day 1 through 126
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Food Science and Human Nutrition Department
state: Florida
city: Ocala
country: United States
facility: UF/IFAS Extension Office Marion County
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy Dahl, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.