Effect of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Men

Inflammation Clinical Trial

— Almond Immune  

Official title:

Effect of Daily Consumption of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Middle -Aged Men: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031663
• Other study ID #: 5210259
• Status: Completed
• Phase: N/A
• Start date: August 12, 2021
• Est. completion date: May 10, 2023

Study information

• Verified date: July 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men

Description:

The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 54 overweight middle-aged men. This study will be carried out in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and Phase 2 will assess the antibody response to influenza vaccination following almond consumption. Participants will attend a baseline clinic and will be randomized to one of two groups. The Almond group will receive 15% of daily energy intake in the form of almonds as a snack and the Control group will receive an isocaloric carbohydrate-based commercial snack (pretzels). The intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 16 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 10, 2023
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

Inclusion Criteria:

• Overweight men (Basal Metabolic Index 25-32)
• Age limit between 40-65 years
• Be able to commute to Loma Linda University

Exclusion Criteria:

• Intolerance or allergy to almonds
• Bad dentures, inability to chew almonds
• Regular intake of almonds and or other nuts
• Use of immune boosting supplements
• Exposure to antibiotics and corticosteroids immediately prior to study
• Have received influenza vaccination in past 10 months
• Uncontrolled chronic disease and psychiatric illness

Related Conditions & MeSH terms

• Immune Response
• Inflammation
• Overweight

Intervention

Dietary Supplement:
• Almond group
Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack
• Control Group
Participants in the control group will receive an isocaloric carbohydrate based commercial snack (pretzel)

Locations

Country	Name	City	State
United States	Loma Linda University School of Public Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in lymphocyte populations	Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells	baseline to 12 weeks
Primary	changes in lymphocyte activity and cytokine production	PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA	baseline to 12 weeks
Primary	changes in natural killer (NK) cell activity	The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a	baseline to 12 weeks
Primary	changes in serum inflammatory cytokine concentration	Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)	baseline to 12 weeks
Primary	changes in complete blood count (CBC)	changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility	baseline to 12 weeks
Primary	changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain	Neutralizing antibody titers in the serum against the hemagglutinin and neuraminidase of the vaccine strain will be measured using the standard commercial ELISA kits	week 12 to 20 weeks
Primary	changes in the viral load in response to vaccination	viral load in blood will be measured using a quantitative polymerase chain reaction (qPCR) protocol as described by Ward CL, et al. (2004	week 12 to 20 weeks
Secondary	changes in upper respiratory infection questionnaire score	Upper respiratory tract infections will be tracked using the Jackson and Dowling questionnaire. The questionnaire will be completed daily by participants, either manually or electronically , throughout the 28-week study period. The scale for the questionnaire is from 0-42. The higher score means worse outcome.	baseline to 28 weeks
Secondary	changes in blood vitamin E levels	Vitamin E levels in the blood will be extracted with hexane, dried and assayed for alpha and gamma tocopherol by high pressure liquid chromatography (HPLC) using a normal-phase diol column and florescence detection according to the method of Kramer and colleagues (2005).	baseline to 28 weeks
Secondary	changes in blood zinc levels	Zinc levels in blood will be analyzed in trace element- free tubes and assayed by atomic absorption spectrophotometry using standard reference material obtained from the National Institute of Standards and Technology to check the accuracy and precision of the determinations	baseline to 12 weeks