Almonds: Digestive Health and Immune Function of Adults and Children

NCT01973595 | Completed Results

• 1 other identifier: 201300475
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

almonds; inflammation; immunity; gut microbiota; stress; diet quality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Inflammatory Status

  Change between Baseline to Week 4

• Gastrointestinal Function

  Pre-baseline (Week 0) and Week 3 of each intervention

• Diet Quality

  Three week almond intervention vs. three week no almond intervention

Study Arms (2)

Almonds then no almonds

EXPERIMENTAL

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

No almonds then almonds

OTHER

No almonds will be consumed by participants for 3 weeks.

Other: No Almonds, Then almonds

Interventions

Almonds, Then no almonds DIETARY_SUPPLEMENT

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

Almonds then no almonds

No Almonds, Then almonds OTHER

No almonds will be consumed by participants for 3 weeks.

No almonds then almonds

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Florida: lead
• Almond Board of California: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• 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.

  PMID: 26773784 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Bobbi Langkamp- Henken
• Organization: University of Florida

henken@ufl.edu

352-392-1991

Study Officials

• Bobbi Langkamp-Henken, PhD, RD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 31, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 26, 2016
• Results First Posted: April 25, 2016

Record last verified: 2016-04

Locations

US (1)