Almonds: Digestive Health and Immune Function of Adults and Children

NCT ID: NCT01973595

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Almonds then no almonds

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.

Group Type: EXPERIMENTAL

Almonds, Then no almonds

Intervention Type: DIETARY_SUPPLEMENT

Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

No almonds then almonds

No almonds will be consumed by participants for 3 weeks.

Group Type: OTHER

No Almonds, Then almonds

Intervention Type: OTHER

No almonds will be consumed by participants for 3 weeks.

Interventions

Almonds, Then no almonds

Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.

Intervention Type: DIETARY_SUPPLEMENT

No Almonds, Then almonds

No almonds will be consumed by participants for 3 weeks.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Almond Board of California

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bobbi Langkamp-Henken, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26773784 (View on PubMed)

Other Identifiers

201300475

Identifier Type: -

Identifier Source: org_study_id