Clinical trial NCT05031663: Effect of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Inflammation
Keywords: Almonds
Immunity
Inflammation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 61
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: this will be a parallel, free-living, randomized controlled trial, where 54 middle-aged men will be randomized to receive either the almonds or a placebo snack
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in lymphocyte populations
timeFrame: baseline to 12 weeks
measure: changes in lymphocyte activity and cytokine production
timeFrame: baseline to 12 weeks
measure: changes in natural killer (NK) cell activity
timeFrame: baseline to 12 weeks
measure: changes in serum inflammatory cytokine concentration
timeFrame: baseline to 12 weeks
measure: changes in complete blood count (CBC)
timeFrame: baseline to 12 weeks
measure: changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain
timeFrame: week 12 to 20 weeks
measure: changes in the viral load in response to vaccination
timeFrame: week 12 to 20 weeks
Secondary outcomes:
measure: changes in upper respiratory infection questionnaire score
timeFrame: baseline to 28 weeks
measure: changes in blood vitamin E levels
timeFrame: baseline to 28 weeks
measure: changes in blood zinc levels
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPh
role: PRINCIPAL_INVESTIGATOR
References: