Clinical trial NCT01973595: Almonds: Digestive Health and Immune Function of Adults and Children
Official title: Almonds: Digestive Health and Immune Function of Adults and Children: a Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: almonds
inflammation
immunity
gut microbiota
stress
diet quality
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2013-10-31
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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. 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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: Gut Microbiota Community Composition
timeFrame: Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention
Secondary outcomes:
measure: Inflammatory Status
timeFrame: Change between Baseline to Week 4
measure: Gastrointestinal Function
timeFrame: Pre-baseline (Week 0) and Week 3 of each intervention
measure: Diet Quality
timeFrame: Three week almond intervention vs. three week no almond intervention
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bobbi Langkamp-Henken, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burns AM, Zitt MA, Rowe CC, Langkamp-Henken B, Mai V, Nieves C Jr, Ukhanova M, Christman MC, Dahl WJ. Diet quality improves for parents and children when almonds are incorporated into their daily diet: a randomized, crossover study. Nutr Res. 2016 Jan;36(1):80-9. doi: 10.1016/j.nutres.2015.11.004. Epub 2015 Nov 10.