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New treatment option for Body Composition Changes
Official title The Precision Nutrition New York Study
ClinicalTrials.gov ID: NCT06777498
What this study is testing
- What it's testing
- Dietary fiber has been shown to have beneficial effects on human health through its impact on microbes present in the gut. However, these effects can vary between individuals, and everyone may not reap the same health benefits by eating the same sources of fiber.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Age is between 21-50 years
- BMI is between 25-30. You can check your BMI here: https://www.cdc.gov/bmi/adult-calculator/index.html
- Must be able to have height, weight, waist, and hip circumference, and body composition measured during the study
- Must be able to provide saliva samples.
- Must be able to provide a phone number and email address at which the study investigators can contact for study-related matters.
You likely can't join if
- Electronic medical implant, for example, a pacemaker.
- An existing, UNTREATED, thyroid condition.
- Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months.
- An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
- A chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal...
- Any suspected state of immunosuppression or immunodeficiency including HIV.
See the full eligibility criteria
- Age is between 21-50 years
- BMI is between 25-30. You can check your BMI here: https://www.cdc.gov/bmi/adult-calculator/index.html
- Must be able to have height, weight, waist, and hip circumference, and body composition measured during the study
- Must be able to provide saliva samples.
- Must be able to provide a phone number and email address at which the study investigators can contact for study-related matters.
- Must be able to increase dietary fiber intake to the recommended level following the instructions on the USDA MyPlate website: https://www.myplate.gov/myplate-plan
- Must be able to provide food records of everything consumed (food, beverage, and supplements) on one weekday and one weekend day (example Tuesday, Saturday) every week during the study. This will be done using an online...
- Must be able to provide 10 stool samples over 11 weeks of the study duration. 18) Must have stable weight (within ±3% of usual body weight) for the last two months.
- Must be able to to take an online survey to assess recent dietary fiber intake to determine eligibility.
- Electronic medical implant, for example, a pacemaker.
- An existing, UNTREATED, thyroid condition.
- Use of systemic antibiotics (intravenous injection, intramuscular, or oral) within the last 4 months.
- An acute disease at the time of enrollment (Acute disease is defined as the presence of a moderate or severe illness with or without fever).
- A chronic, clinically significant (unresolved, requiring ongoing medical management or medication) pulmonary, cardiovascular, gastrointestinal, hepatic, or renal functional abnormality.
- Any suspected state of immunosuppression or immunodeficiency including HIV.
- A history of active UNTREATED gastrointestinal disorders or diseases including
- Inflammatory bowel disease (IBD)
- Ulcerative colitis (mild-moderate-severe)
- Crohn's or celiac disease
- Indeterminate colitis
- Irritable bowel syndrome (IBS) (moderate-severe)
- Persistent, infectious gastroenteritis, colitis or gastritis
- Persistent or chronic diarrhea of unknown etiology
- Clostridium difficile infection (recurrent)
- Chronic constipation
- Previously had bariatric surgery.
- An unstable dietary history as defined by major changes in diet during the previous month. For example, elimination or significantly increased intake of a major food group in the diet.
- Recent history of chronic alcohol consumption defined as more than 5 drinks (or servings) of alcohol per day.
- Female participants: pregnant/lactating.
The study team makes the final eligibility decision.
Where it's taking place
- Ithaca, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ithaca, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.