The Effects of Almond Consumption on Functional Performance and Activity in Overweight Active Older Adults

NCT04778371 | Active Not Recruiting

• 1 other identifier: 00001394
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this proposed randomized, crossover study is to determine the effect of 12 weeks of almond consumption, ingested as a snack twice daily, on energy expenditure, performance and functional related outcomes, in active, overweight, older adults, in comparison to 12 weeks of an isocaloric matched control snack. The central hypothesis of this study is, due to the nutritionally beneficial composition of almonds, that daily consumption of an almond snack for 12 weeks will contribute to improvements in energy expenditure, physical and functional performance, vascular function, inflammation/oxidative stress, sleep quality, mood status, and body composition in active, overweight and obese older adults compared to an isocaloric commercially available snack.

Conditions

Overweight

Keywords

almond; functional performance; aerobic capacity; physical activity

Outcome Measures

Primary Outcomes (2)

• Effect of almonds on functional performance

  Functional performance assessed by the Continuous-Scale Physical Functional Performance Test.

  1 year

• Effect of almonds on submaximal aerobic capacity (VO2)

  -treadmill test ending at 85 % max VO2 measured using ParvoMedics metabolic cart with VO2 units reported in ml/(kg\*min)-1

  1 year

Secondary Outcomes (7)

• Effect of almond on resting metabolic rate (RMR)

  1 year

• Effect of almond on body fat

  1 year

• Effect of almond on lean body mass

  1 year

• Effect of Almond on sleep pattern

  1 year

• Effect of Almond on arterial health using flow mediated dilation

  1 year

Study Arms (2)

Almond supplement

EXPERIMENTAL

Participants will consume 32 g dry roasted, unsalted almonds twice a day for 12 weeks

Other: Almonds

Placebo matched supplement

PLACEBO COMPARATOR

Participants will consume 100 g granola bar, calorie matched to Almond, twice a day for 12 weeks

Other: Placebo

Interventions

Almonds OTHER

64 g total dry roasted, unsalted almonds per day for a total of 12 weeks

Almond supplement

Placebo OTHER

200 g total calorie matched granola bar per day for total of 12 weeks

Placebo matched supplement

Eligibility Criteria

• Age: 50 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• physically active men and postmenopausal women (free of menstruation for 12 consecutive months)
• Between the ages of 50-59 years
• Free of any chronic diseases such as cancer
• Active lifestyle (\>30 minutes, 3 days/week)
• BMI of 25.0 kg/m2 to 29.9 kg/m2 will be included
• There will be no restrictions based on race, ethnicity, or socioeconomic status.

You may not qualify if:

• Individuals diagnosed with cardiovascular diseases (CVD) Type 2-diabetes
• Uncontrolled hypertension (≥160/100 mmHg)
• BMI \<25.0 kg/m2 or \>29.9 kg/m2
• Other active chronic diseases such as cancer, asthma, glaucoma, kidney, liver and pancreatic disease
• Those who are not post-menopausal or on hormone replacement therapy
• Taking more than one anti-hypertensive or have been taking them for less than 3 months -Any musculoskeletal or orthopedic problem that would otherwise prevent completing the study Participants participating in a weight loss program or having lost or gain ≥10% bodyweight within the last 6 months
• Currently using tobacco
• Consumption of \>12 alcoholic drinks/week
• Nut allergies
• Frequent tree nut consumers (\>2 servings/week)
• In concurrent participation with another investigational study
• Currently consuming any performance supplement (i.e. creatine, nitric oxide, whey/casein protein, branched chain amino acids).

Sponsors & Collaborators

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

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Overweight; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Robert Hickner, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, calorie-match controlled, crossover design

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: March 3, 2021
• Study Start: March 2, 2021
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)