Almonds: Digestive Health and Immune Function of Adults and Children

Study Overview
=================
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.

Official Title
-----------------
Almonds: Digestive Health and Immune Function of Adults and Children: a Randomized Crossover Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Almonds, Then no almonds
* Other: No Almonds, Then almonds


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almonds then no almonds<br>Adults will consume 1.5 ounces of almonds or almond paste per day and children will consume 0.5 ounces of almonds or almond paste per day for 3 weeks. | Dietary Supplement: Almonds, Then no almonds<br>* Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.<br>|
| Other: No almonds then almonds<br>No almonds will be consumed by participants for 3 weeks. | Other: No Almonds, Then almonds<br>* No almonds will be consumed by participants for 3 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut Microbiota Community Composition | The mean of the change between baseline and final time points in stool lactic acid bacteria counts [log(CFU)] was compared for each study arm. | Baseline #1 (Week 1) to Final #1 (Week 4) of each intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Status | Levels of inflammatory markers in the blood (IL-6) were compared between baseline and final time points once the participants were on the Almonds intervention.. The data were collected at Baseline and Week four. | Change between Baseline to Week 4 | 
| Gastrointestinal Function | Changes in average number of stools per week were measured using a Daily Questionnaire. Results were compared between treatment periods for each subject/group. | Pre-baseline (Week 0) and Week 3 of each intervention | 
| Diet Quality | Three dietary recalls occurred per study arm, and each recall was scored for quality. The quality scores were averaged per arm and then compared between study arms for each subject/group using the Healthy Eating Index-2010.The Healthy Eating Index assesses diet quality based on 12 components, when summed has maximum points of 100 (HEI scale 0-100). High component scores indicate intakes close to the recommended ranges or amounts; low component scores indicate less compliance with the recommended ranges or amounts. National averages total score: children: 54.9 [4-8 years] and adults: 57.4 [31-50 years]) | Three week almond intervention vs. three week no almond intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
almonds, inflammation, immunity, gut microbiota, stress, diet quality