Almonds: Digestive Health and Immune Function of Adults and Children
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 3/1/2014 |
| Start Date: | December 2013 |
| End Date: | May 2014 |
| Contact: | Bobbi Langkamp-Henken, PhD, RD |
| Email: | henken@ufl.edu |
| Phone: | 352-392-1991 |
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, increased antioxidant status,
improved immune function, decreased inflammation, and decreased perceived stress during the
almond intervention.
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, increased antioxidant status,
improved immune function, decreased inflammation, and decreased perceived stress during the
almond intervention.
This is a randomized, crossover study. After obtaining informed consent, healthy adults aged
18-40 years with children aged 3-6 years will be randomized to either consume almonds and
almond paste during the first arm of the study or during the second arm of the study. During
the intervention period, adult participants will consume 1.5 ounces of almonds per day, and
children will consume 0.5 ounces of almonds per day for 3 weeks. After a 4-week washout
period, participants will be crossed to the other treatment (no almond consumption or almond
consumption).
Participants will complete daily questionnaires throughout the intervention period, and one
week before and after each intervention period. Saliva samples will be collected from adults
and children and blood samples will be collected from adults at the baseline and final time
points of each intervention. Stool samples will be collected during the pre-baseline and
final weeks of each intervention. Dietary intake will be assessed weekly during each
intervention period. Gastrointestinal symptoms questionnaires will be completed weekly
during each intervention, and a perceived stress questionnaire will be completed by adults
at the beginning and end of each intervention period.
18-40 years with children aged 3-6 years will be randomized to either consume almonds and
almond paste during the first arm of the study or during the second arm of the study. During
the intervention period, adult participants will consume 1.5 ounces of almonds per day, and
children will consume 0.5 ounces of almonds per day for 3 weeks. After a 4-week washout
period, participants will be crossed to the other treatment (no almond consumption or almond
consumption).
Participants will complete daily questionnaires throughout the intervention period, and one
week before and after each intervention period. Saliva samples will be collected from adults
and children and blood samples will be collected from adults at the baseline and final time
points of each intervention. Stool samples will be collected during the pre-baseline and
final weeks of each intervention. Dietary intake will be assessed weekly during each
intervention period. Gastrointestinal symptoms questionnaires will be completed weekly
during each intervention, and a perceived stress questionnaire will be completed by adults
at the beginning and end of each intervention period.
Inclusion Criteria:
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.
Exclusion Criteria:
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 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 GERD; or have a central venous
catheter.
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