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Recruiting NCT07235358

Cardiometabolic Effects of Pecan Snacking in Prediabetes

No phase Interventional Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pecan snacking, Usual diet.
Who it may be relevant to
Registry conditions: Prediabetes. Basic parameters: 25 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Glycemic Effects of Substituting Pecans for Snacks Higher in Saturated Fat and Added Sugars in Individuals With Prediabetes

Overview

The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

Detailed description

This is a 16-week randomized controlled trial. Participants will be randomized to either: 1) replace current snacks higher in saturated fat and added sugars with 1.5 oz/day of pecans; 2) continue their habitual diet. At the beginning and the end of the 16-week study period, testing will be conducted.

Interventions

  • Behavioral Pecan snacking
    Replacement of typically consumed snacks with 1.5 oz/day of pecans
  • Other Usual diet
    Continue with usual diet

Primary outcome measures

  • Change in HbA1c [Time frame: 16 weeks]
Secondary outcome measures (12)
  • Change in fasting glucose [Time frame: 16 weeks]
  • Change in mean glucose [Time frame: 16 weeks]
  • Change in mean time in range [Time frame: 16 weeks]
  • Change in glycemic variability [Time frame: 16 weeks]
  • Change in fasting insulin [Time frame: 16 weeks]
  • Change in homeostatic model of insulin resistance (HOMA-IR) [Time frame: 16 weeks]
  • Change in the lipoprotein insulin resistance index [Time frame: 16 weeks]
  • Change in LDL-Cholesterol [Time frame: 16 weeks]
  • Change in apolipoprotein B [Time frame: 16 weeks]
  • Change in non-HDL cholesterol [Time frame: 16 weeks]
  • Change in Total Cholesterol [Time frame: 16 weeks]
  • Change in HDL-Cholesterol [Time frame: 16 weeks]

Eligibility criteria

Inclusion criteria

  • Age 25-65 years
  • Prediabetes assessed by an HbA1c of 5.7-6.4% at screening
  • BMI 25-40 kg/m2 at screening
  • Low habitual nut consumption (<3.5 oz-eq/week) assessed at the telephone screening
  • Regularly eats snacks higher in saturated fat and/or added sugars assessed at the telephone screening

Exclusion criteria

  • LDL-C ≥190 mg/dL at screening
  • Hemoglobin <13.2 g/dL at screening
  • Fasting triglycerides >350 mg/dL at screening
  • ≥10% change in body weight within the 6 months prior to enrollment
  • Blood pressure >140/90 mmHg at screening
  • Type 1 or type 2 diabetes
  • Prescription of anti-hypertensive, lipid-lowering, or glucose-lowering drugs
  • Intake of supplements or over-the-counter medications that affect the outcomes of interest (i.e., lipid, blood pressure, or glucose lowering; vitamin C or multi-vitamins containing vitamin C) and are unwilling to cease during the study period.
  • History of liver, kidney, or autoimmune disease
  • Prior cardiovascular event (e.g., stroke, heart attack)
  • Current pregnancy or intention of pregnancy within the next 12 months
  • Lactation within the prior 6 months
  • Pecan allergy/intolerance/sensitivity/dislike
  • Unwilling/unable to eat 1.5 oz of pecans every day as a snack during the duration of the study
  • Antibiotic use within the prior 4 weeks
  • Oral steroid use within the prior 4 weeks
  • Use of tobacco or nicotine-containing products within the past 6 months
  • History of cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer within the past 5 years (eligible if ≥5 years without recurrence)
  • Participation in another clinical trial within 60 days of baseline
  • Unwilling to contact study staff before enrolling in other health-related research and avoid participating in any research that may interfere with this study.
  • Currently following a restricted or weight-loss diet
  • Prior bariatric surgery
  • Intake of >14 alcoholic drinks/week and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
  • Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements, including being able to come to attend visits
  • Does not speak and/or understand English
  • Unwilling to refrain from donating blood or plasma during the study
  • Weight <110 lb
  • If a potential participant takes thyroid medicine, abnormal thyroid stimulated hormone (TSH) concentration (TSH outside of normal range), or change in dose of thyroid medication within the last 6 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • The Pennsylvania State University — University Park

Identifiers

NCT: NCT07235358 · PEC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗