NCT07227259

Brief Summary

The main goal of this clinical study is to see if consuming pecan nuts will result in improvements in overall body metabolism such as in blood lipids, markers of inflammation, blood pressure, cognitive performance and changes in bacteria living in the gut in adults 45 to 75 years of age. Participants will take part in two 3-month intervention periods, separated by 4-6 weeks, in random order ( a total of approximately 7 months). During one intervention period, they will include pecan nuts in their diet each day, while during the other intervention period they will avoid pecans in their diet. There will be an initial screening visit to evaluate eligibility and four study visits to the clinic. Participants will be asked to complete some questionnaires about their diet, physical and cognitive health, and provide blood and stool samples, and have their blood pressure measured.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

November 9, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

November 9, 2025

Last Update Submit

February 20, 2026

Conditions

Healthy Adults

Keywords

pecan nutcardiovasculargut microbiomecognitive

Outcome Measures

Primary Outcomes (1)

  • Change in vascular response at 3 months

    Vascular response as measured by Pulse Wave Velocity (PWV)

    Change from baseline at 3 months

Secondary Outcomes (16)

  • Change in blood lipids over 3 months

    Change from baseline at 3 months

  • Change in markers of inflammation at 3 months

    change from baseline at 3 months

  • Change in gut microbiome profile at 3 months

    Change from baseline at 3 months

  • Change in blood markers of intestinal permeability at 3 months.

    Change from baseline at 3 months

  • Change in blood markers of intestinal permeability at 3 months

    Change from baseline at 3 months

  • +11 more secondary outcomes

Study Arms (2)

Pecan nut then no nut

EXPERIMENTAL

Participant will add pecan nuts to their diet during the first intervention arm, then they will cross over to the no nut diet arm

Other: pecan nut

No nut then pecan nut

EXPERIMENTAL

Participant will consume a diet without nuts during the first intervention arm, then they will cross over to the arm where they will add pecan nuts to their diet.

Other: pecan nut

Interventions

pecan nutOTHER

Dose - 2 ounces of pecan nuts, daily

No nut then pecan nutPecan nut then no nut

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 20-35 kg/m2, ability to understand the intervention instructions, Willingness to follow the dietary intervention, Willingness to provide biological samples (blood and stool) -

You may not qualify if:

  • Allergy to pecan or other nuts, Cognitive impairment due to dementia of any type and inability to understand or comply with intervention instructions, Use of menopausal hormone replacement therapy, Use of antibiotics or probiotics in the 2 months prior to enrollment, Uncontrolled diabetes with HbA1C of \>9.5, Vegetarian/vegan, Any serious medical condition (such as chronic kidney disease of stage 3 or greater, heart failure, active cancer treatment, inflammatory bowel disease, etc.), Consumption of supplements that may interfere with vascular response or gut microbiome, Use of statin drugs for cholesterol lowering.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragle Human Nutrition Center, UC Davis campus

Davis, California, 95616, United States

RECRUITING

Central Study Contacts

Francene Steinberg, PhD

CONTACT

530-752-0160fmsteinberg@ucdavis.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2025

First Posted

November 12, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)