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

Loma Linda University (LLU)

Status: Completed

Conditions: Immune Response; Inflammation

Treatments: Dietary Supplement: Almond group; Dietary Supplement: Control Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05031663

5210259

Details and patient eligibility

About

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

Full description

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.

Enrollment: 61 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups, including a placebo group

Almonds

Experimental group

Description:

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

Treatment:

Dietary Supplement: Almond group

Control

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Control Group