OverweightNCT04778371
The Effects of Almond Consumption on Functional Performance and Activity in Overweight Active Older Adults
A study testing Almonds in people with Overweight, run by Florida State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Almonds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 50 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.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: The Effects of Almond Consumption on Functional Performance, Aerobic Capacity, and Physical Activity in Overweight Active Older Adults
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.
Read the detailed description
By 2030 it estimated that 20% of individuals in the United States (U.S.) will be 65 years of age or older, indicating a shift in demographics over the past century. The aging process is strongly associated with reduced aerobic capacity and functional performance as well as increases in inflammation and oxidative stress. With differences in the demographic profile, eating patterns have also changed for Americans within the past 30 years, with a majority of Americans consuming at least one snack/day; with the types of snacks consumed being processed foods that are high in refined carbohydrates, saturated fats, and low in fiber. Additionally, the aging process contributes to decreases in RMR, which can promote alterations in body composition. Lifestyle modifications have been shown to contribute to beneficial outcomes associated with aging. Therefore, healthy, nutrient-dense foods are of primary importance for enhancing functional performance, aerobic capacity, and physical activity as well as improving vascular function, body composition, and markers of inflammation/oxidative stress within this growing population. Tree nuts are a nutrient- and energy dense food, which may contribute to increases in RMR due to their high amounts of poly- and monounsaturated fatty acids affecting diet-induced thermogenesis. Almonds (Prunus dulcis) are an excellent source of α-tocopherol and a good source of monounsaturated fat, magnesium, fiber, and protein. When compared to other nuts almonds have the greatest amount of fiber and protein. Almond supplementation has been shown to attenuate age-related decline in aerobic fitness and physical performance measures. Few studies have assessed how almonds alone affect fitness and physical function. However, Yi et al. found that in young healthy, endurance trained individuals, consumption of almonds elevated serum arginine, nitric oxide and TAC, all of which contributed to improved exercise performance. Constituents of almonds including L-arginine and magnesium have been shown to increase anaerobic threshold and physical performance in healthy active older adults respectively . Studies have found that the incorporation of almonds in a diet can decrease oxidative stress and improve vascular function. Improvements in both FMD and systolic blood pressure were shown after 4 weeks of almond consumption in healthy old and young men. L-arginine, an amino acid vital for synthesis of nitric oxide, which controls vascular tone, is also found in almonds. Almonds are often cited as a healthy, protein-boosting snack, beneficial for sustaining muscle mass and metabolism, without increasing fat mass or total energy intake. Additionally, studies have demonstrated that body weight and body mass index (BMI) remain unchanged during almond supplementation interventions. Almond consumption has also been shown to decrease visceral fat and body fat percentage. The extent to which daily almond consumption affects functional performance, aerobic capacity, energy expenditure, vascular function, body composition and inflammation/oxidative stress in active overweight and obese older adults needs to be investigated.
For this study, fifty men and postmenopausal women will follow a randomized-controlled crossover design. If individuals qualify for participation after the screening visit, they will be asked to complete a 3-day food record and wear an ActiGraph to track physical activity and sleeping patterns for the next seven days, to be returned at their Baseline Study Visit #1. During the Baseline Study Visit #1 assessments of: RMR, body composition (DXA), vascular assessments (FMD, PWV, PWA, blood pressure), heart rate, anthropometrics (height, weight, and waist/hip circumference), venous blood draw, POMS, and sleep quality (PSQI) will be collected. The following day, participants will return for their Baseline Physical Performance Visit #1 to complete assessments of submaximal aerobic capacity and the CS-PFP. Following this visit, participants will be provided with 12 weeks of almonds or the isocaloric snack. Participants will be asked to come in after 6 weeks to receive the rest of their dietary regimen and to monitor compliance. During week 11, participants will be asked to come to the study site to be given a 3-day food record and the ActiGraph to be retuned at the Post-Test Study Visit #1. After 12 weeks, participants will return to FSU to complete their Post-Test Study Visit #1, which will involve all the same assessments from the baseline study visit, as well as their Post-Test Physical Performance Visit #1, the next day. After the 4-week washout period, participants will similarly be asked to complete a 3-day food record and wear an ActiGraph for the following 7 days, to be returned upon the participants' Baseline Study Visit #2, where participants will crossover into receiving the corresponding dietary regimen and will follow the same procedures for the following 12 weeks.
- Conditions
- Overweight
- Being tested
- Almonds, Placebo
- Keywords
- almond, functional performance, aerobic capacity, physical activity
- Medical subject headings
- Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmondsOther
64 g total dry roasted, unsalted almonds per day for a total of 12 weeks
PlaceboOther
200 g total calorie matched granola bar per day for total of 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Almond supplement | Experimental | Participants will consume 32 g dry roasted, unsalted almonds twice a day for 12 weeks Receives: Other: Almonds |
| Placebo matched supplement | Placebo comparator | Participants will consume 100 g granola bar, calorie matched to Almond, twice a day for 12 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of almonds on functional performance
Functional performance assessed by the Continuous-Scale Physical Functional Performance Test.
Measured: 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
Measured: 1 year
Secondary outcomes (7)
Effect of almond on resting metabolic rate (RMR)
Resting metabolic rate as measured using the Parvomedics Metabolic Cart with resting metabolic rate being reported as VO2 in liters/minute.
Measured: 1 year
Effect of almond on body fat
measured by duel energy x-ray absorptiometry and body fat reported as a percentage of total mass, in units of %.
-
Measured: 1 year
Effect of almond on lean body mass
measured by duel energy x-ray absorptiometry and reported as lean body mass in kilograms.
Measured: 1 year
Effect of Almond on sleep pattern
Actigraph watch worn for 1 week prior to baseline and post-tests
-monitors sleep activity and reported in units of minutes.
Measured: 1 year
Effect of Almond on arterial health using flow mediated dilation
Measure of flow-mediated dilation (FMD) via use of the Philips HD11XE Doppler Ultrasound, which measures the ability of an artery to expand (dilate) in response to sheer stress caused by an increase in blood flow.
-Brachial artery FMD will be examined using a linear array transducer and will be reported in units of %.
Measured: 1 year
Effect of Almond on arterial health using pulse wave velocity
-Measured using the Automated Pulse-Wave Velocity (PWV) Device (VP-2000, Omron Healthcare Inc.) with PWV being the velocity at which the blood pressure pulse is conducted through the circulatory system via an artery or a combined series and length of arteries. Used to measure arterial stiffness and reported in units of m/sec.
Measured: 1 year
C-reactive protein
Measured via fasting blood draw 20 ml using ELISA analyses and reported in units of nmol/L
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start2 Mar 2021
- Primary completion1 Sep 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, calorie-match controlled, crossover design
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Almond Board of California
- Responsible party
- Principal investigator, Bob Hickner, Florida State University
- Investigators
- Robert Hickner, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778371
- Sponsor's protocol ID
- 00001394
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Almond Consumption on Functional Performance, Aerobic Capacity, and Physical Activity in Overweight Active Older Adults
- ClinicalTrials.gov ID
- NCT04778371
- Acronym / sponsor ID
- 00001394
- Conditions
- Overweight
- Keywords
- almond, functional performance, aerobic capacity, physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Almond Board of California
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
By 2030 it estimated that 20% of individuals in the United States (U.S.) will be 65 years of age or older, indicating a shift in demographics over the past century. The aging process is strongly associated with reduced aerobic capacity and functional performance as well as increases in inflammation and oxidative stress. With differences in the demographic profile, eating patterns have also changed for Americans within the past 30 years, with a majority of Americans consuming at least one snack/day; with the types of snacks consumed being processed foods that are high in refined carbohydrates, saturated fats, and low in fiber. Additionally, the aging process contributes to decreases in RMR, which can promote alterations in body composition. Lifestyle modifications have been shown to contribute to beneficial outcomes associated with aging. Therefore, healthy, nutrient-dense foods are of primary importance for enhancing functional performance, aerobic capacity, and physical activity as well as improving vascular function, body composition, and markers of inflammation/oxidative stress within this growing population. Tree nuts are a nutrient- and energy dense food, which may contribute to increases in RMR due to their high amounts of poly- and monounsaturated fatty acids affecting diet-induced thermogenesis. Almonds (Prunus dulcis) are an excellent source of α-tocopherol and a good source of monounsaturated fat, magnesium, fiber, and protein. When compared to other nuts almonds have the greatest amount of fiber and protein. Almond supplementation has been shown to attenuate age-related decline in aerobic fitness and physical performance measures. Few studies have assessed how almonds alone affect fitness and physical function. However, Yi et al. found that in young healthy, endurance trained individuals, consumption of almonds elevated serum arginine, nitric oxide and TAC, all of which contributed to improved exercise performance. Constituents of almonds including L-arginine and magnesium have been shown to increase anaerobic threshold and physical performance in healthy active older adults respectively . Studies have found that the incorporation of almonds in a diet can decrease oxidative stress and improve vascular function. Improvements in both FMD and systolic blood pressure were shown after 4 weeks of almond consumption in healthy old and young men. L-arginine, an amino acid vital for synthesis of nitric oxide, which controls vascular tone, is also found in almonds. Almonds are often cited as a healthy, protein-boosting snack, beneficial for sustaining muscle mass and metabolism, without increasing fat mass or total energy intake. Additionally, studies have demonstrated that body weight and body mass index (BMI) remain unchanged during almond supplementation interventions. Almond consumption has also been shown to decrease visceral fat and body fat percentage. The extent to which daily almond consumption affects functional performance, aerobic capacity, energy expenditure, vascular function, body composition and inflammation/oxidative stress in active overweight and obese older adults needs to be investigated.
For this study, fifty men and postmenopausal women will follow a randomized-controlled crossover design. If individuals qualify for participation after the screening visit, they will be asked to complete a 3-day food record and wear an ActiGraph to track physical activity and sleeping patterns for the next seven days, to be returned at their Baseline Study Visit #1. During the Baseline Study Visit #1 assessments of: RMR, body composition (DXA), vascular assessments (FMD, PWV, PWA, blood pressure), heart rate, anthropometrics (height, weight, and waist/hip circumference), venous blood draw, POMS, and sleep quality (PSQI) will be collected. The following day, participants will return for their Baseline Physical Performance Visit #1 to complete assessments of submaximal aerobic capacity and the CS-PFP. Following this visit, participants will be provided with 12 weeks of almonds or the isocaloric snack. Participants will be asked to come in after 6 weeks to receive the rest of their dietary regimen and to monitor compliance. During week 11, participants will be asked to come to the study site to be given a 3-day food record and the ActiGraph to be retuned at the Post-Test Study Visit #1. After 12 weeks, participants will return to FSU to complete their Post-Test Study Visit #1, which will involve all the same assessments from the baseline study visit, as well as their Post-Test Physical Performance Visit #1, the next day. After the 4-week washout period, participants will similarly be asked to complete a 3-day food record and wear an ActiGraph for the following 7 days, to be returned upon the participants' Baseline Study Visit #2, where participants will crossover into receiving the corresponding dietary regimen and will follow the same procedures for the following 12 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, calorie-match controlled, crossover design
| Arm | Type | Receives |
|---|---|---|
| Almond supplement | Experimental | Other: AlmondsParticipants will consume 32 g dry roasted, unsalted almonds twice a day for 12 weeks |
| Placebo matched supplement | Placebo comparator | Other: PlaceboParticipants will consume 100 g granola bar, calorie matched to Almond, twice a day for 12 weeks |
Who may qualify
- Ages
- 50 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 50 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Almonds64 g total dry roasted, unsalted almonds per day for a total of 12 weeks | Other | Almond supplement |
| Placebo200 g total calorie matched granola bar per day for total of 12 weeks | Other | Placebo matched supplement |
Primary outcome
Effect of almonds on functional performance
Time frame: 1 year
Functional performance assessed by the Continuous-Scale Physical Functional Performance Test.
Effect of almonds on submaximal aerobic capacity (VO2)
Time frame: 1 year
-treadmill test ending at 85 % max VO2 measured using ParvoMedics metabolic cart with VO2 units reported in ml/(kg*min)-1
7 secondary outcomes
Effect of almond on resting metabolic rate (RMR)
Time frame: 1 year
Effect of almond on body fat
Time frame: 1 year
Effect of almond on lean body mass
Time frame: 1 year
Effect of Almond on sleep pattern
Time frame: 1 year
Effect of Almond on arterial health using flow mediated dilation
Time frame: 1 year
Effect of Almond on arterial health using pulse wave velocity
Time frame: 1 year
C-reactive protein
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hickner, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Almonds in people with Overweight, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of almonds on functional performance (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.