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

Completed · Not applicable · Has a placebo group

Conditions studied: Aging

In brief

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.

Key facts

Study ID

NCT02445560

Run by

University of Florida

People needed

29

Starts

2015-06-01

Expected to finish

2015-10-01

Last updated by the study team

2018-03-29

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UF Food Science and Human Nutrition Department — Gainesville, Florida, United States
• UF/IFAS Extension Office Marion County — Ocala, Florida, United States

Full record on ClinicalTrials.gov

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