Almonds: Digestive Health and Immune Function of Adults and Children

Completed · Not applicable

Conditions studied: Healthy

In brief

The purpose of this study is to determine whether incorporating almonds into the diets of families with young children will induce beneficial changes in gastrointestinal function, the fecal microbiota profile, and immune and inflammatory processes of the adults and children resulting in improved quality of life. The investigators anticipate finding an increase in beneficial bacteria, improved intestinal function, and decreased inflammation during the almond intervention.

Key facts

Study ID

NCT01973595

Run by

University of Florida

People needed

58

Starts

2013-12-01

Expected to finish

2014-05-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To participate in the study, adult participants must:
• Be 18 to 40 years old.
• Have a 3 to 6 year old child that you are willing to enroll in the study.
• Live with your child for on average at least 6 days of the week.
• Be willing and able to complete the Informed Consent Form in English.
• Not be currently pregnant or planning to become pregnant in the next 5 months.
• Be willing to consume 1.5 ounces of almonds (\~43 nuts) each day for three weeks.
• Be willing to feed your child 0.5 ounces of almond paste (\~2 tablespoons) per day for three weeks.
• Be willing monitor your child's daily intake over the course of the study.
• Be willing to provide 4 blood samples, 4 stool samples, and 4 saliva samples over the course of the study.
• Be willing to assist your child in providing 4 stool samples and 4 saliva samples over the course of the study.
• Be willing and able to complete daily and weekly questionnaires for you and your child regarding general wellness, bowel function, gastrointestinal symptoms, stress and anxiety, and dietary intake.
• Must be available for 14 consecutive weeks to participate in the study.

You may not qualify if…

• To participate in the study, adult and child participants:
• Must not have any known nut or tree nut allergies.
• Must discontinue any immune-enhancing dietary supplements (e.g., prebiotics and fiber supplements, probiotics, fish oil, vitamin E >400% of the Recommended Dietary Allowance (RDA) or >60 mg/day, and yogurts with live, active cultures).
• Must not be currently taking any medications for constipation or diarrhea on a regular basis.
• Must not be currently taking any large doses of anti-inflammatory drugs (i.e., aspirin in doses >600 mg/d) on a regular basis.
• Must not have received antibiotic therapy or a colonoscopy in the past two months.
• Must not be currently being treated for or have any of the following physician-diagnosed diseases or conditions: HIV/AIDS; immune modulating diseases (autoimmune disease, hepatitis, cancer); kidney disease; pancreatitis; pulmonary disease; hepatic or biliary disease; or gastrointestinal diseases/conditions such as diverticulitis, ulcerative colitis, Crohn's disease, Celiac disease, short bowel disease, ileostomy, or colostomy, but not including gastroesophageal reflux disease; or have a central venous catheter.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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