Effect of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Older Men and Postmenopausal Women: A Randomized Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-12

Study Completion Date

2023-05-10

Brief Summary

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

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Detailed Description

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The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 66 overweight middle-aged men and post menopausal women. 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 continue thier usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week. 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 28 weeks.

Conditions

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Immune Response Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

this will be a parallel, free-living, randomized controlled trial, where 66 middle-aged men and post menopausal women will be randomized to receive either the almonds or control

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The investigator and outcome assessor will not be aware which participant is in what arm. The participant and the care provider will know about the treatment allocation

Study Groups

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Almonds

The almond group will receive 15% of their daily energy intake in the form of almonds

Group Type EXPERIMENTAL

Almond group

Intervention Type DIETARY_SUPPLEMENT

Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack

Control

The control group will be encouraged to continue their usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type DIETARY_SUPPLEMENT

The control group will continue their usual diet but will completely avoid almonds and restrict other nuts to less than 2 servings per week

Interventions

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Almond group

Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack

Intervention Type DIETARY_SUPPLEMENT

Control Group

The control group will continue their usual diet but will completely avoid almonds and restrict other nuts to less than 2 servings per week

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Overweight men and post menopausal women (Basal Metabolic Index 25-32)
* Age limit between 40-70 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

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes