NCT07732816

Brief Summary

You are invited to participate in a research study being conducted by Karen Gibson, Maria Morgan-Bathke, Dana Swope, Grace Huebner, Rebecca Brannan, Samuel McCormick at Viterbo University. The purpose of this research is to determine the effectiveness of using nuts and avocados as a dietary intervention on improving fasting blood glucose, lipid profile, energy expenditure, and body composition on pre-diabetic individuals compared to a control group. We hope to learn if a dietary intervention of nuts or avocado can help improve blood sugar, lipid panel and/or body composition. You were selected as a possible participant in this study because you have been diagnosed with pre-diabetes. If you decide to participate, you will be asked to complete an initial two hour appointment, follow the protocol of one of the interventions (one avocado or 1 ½ ounce nuts) and control group with only dietary counseling provided) daily for an eight week period, weekly telephone and/or email nutrition counseling, and attend a final two hour appointment. The food for the intervention (avocados and nuts) will be provided by the researchers and will not need to be purchased by the participants. The initial and final two hour appointments will consist of the following measurements: An overnight fast, blood glucose, cytokine level, and lipid panel tests will be completed by a venous blood draw. Then Maltron scan (to measure body composition, which in non-invasive and uses electrodes on the skin), waist/hip measurements, height/weight, and VioCare food frequency questionnaire will be completed. Following these screening measurements, a COSMED test to determine resting energy expenditure (REE) will be measured. It may take approximately 10 weeks from beginning to completion of this study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

2 years

First QC Date

July 15, 2026

Last Update Submit

July 24, 2026

Conditions

Obesity & Overweight

Keywords

obesitymonounsaturated fatty acidspecanscardiometabolic healthinflammationdietary intake

Outcome Measures

Primary Outcomes (8)

  • body composition

    percentage body fat

    10 weeks

  • fasting blood glucose

    fasting blood glucose in mg/dl

    10 weeks

  • weight

    weight in kg

    10 weeks

  • height

    height in meters

    10 weeks

  • total cholesterol

    total cholesterol in mg/dl

    10 weeks

  • LDL cholesterol

    LDL cholesterol in mg/dl

    10 weeks

  • HDL

    HDL cholesterol in mg/dl

    10 weeks

  • TG

    triglycerides in mg/dl

    10 weeks

Secondary Outcomes (2)

  • inflammation

    10 weeks

  • anti-inflammatory

    10 weeks

Study Arms (2)

control

NO INTERVENTION

control group

pecan group

EXPERIMENTAL

pecan intervention

Other: Pecan Intervention

Interventions

Pecan InterventionOTHER

1.5 oz of pecans daily

pecan group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- BMI of 25.0-40.0

You may not qualify if:

  • BMI below 25.0 or over 40.0
  • anyone who works a 3rd shift
  • pregnant and breastfeeding women
  • those with pre-existing chronic conditions
  • those with a latex allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityOverweightInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Maria Morgan-Bathke, PhD

    Viterbo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 29, 2026

Study Start

October 17, 2016

Primary Completion

October 17, 2018

Study Completion

October 17, 2018

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share