NCT07853898

Brief Summary

This randomized controlled crossover study will examine the acute effects of pistachio consumption on postprandial metabolic responses in adults with overweight or obesity. Participants will complete two experimental conditions in randomized order. In one condition, participants will consume 30 g of pistachios with a standardized meal, and in the other condition they will receive an isocaloric refined-carbohydrate control condition with the standardized meal. The study will evaluate postprandial insulin and glucose responses over approximately 3 hours after meal consumption. Additional outcomes will include continuous glucose monitoring measures, blood lipid responses, appetite and satiety ratings, and exploratory measures related to insulin sensitivity and gastrointestinal hormone responses. The study is designed to determine whether pistachio consumption alters acute metabolic responses compared with an isocaloric refined-carbohydrate control in adults with overweight or obesity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 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 Progress1%
Oct 2026Jul 2027

First Submitted

Initial submission to the registry

September 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 26, 2026

Last Update Submit

September 26, 2026

Conditions

Keywords

PistachiosPostprandial glucosePostprandial insulinMetabolic responseInsulin sensitivityContinuous glucose monitoringAppetite

Outcome Measures

Primary Outcomes (1)

  • Postprandial Insulin Incremental Area Under the Curve (iAUC)

    Postprandial plasma insulin will be measured at 0, 30, 60, 90, 120, 150, and 180 minutes after meal consumption. Insulin incremental area under the curve (iAUC) from 0 to 180 minutes will be calculated using the trapezoidal rule with baseline subtraction. Insulin iAUC will be compared between the pistachio and refined-carbohydrate control conditions.

    0-180 minutes after meal consumption

Secondary Outcomes (10)

  • Postprandial Plasma Glucose Incremental Area Under the Curve (iAUC)

    0-180 minutes after meal consumption

  • Continuous Glucose Monitoring Time in Range

    0-180 minutes after meal consumption

  • Continuous Glucose Monitoring Mean Glucose

    0-180 minutes after meal consumption

  • Continuous Glucose Monitoring Glycemic Variability

    0-180 minutes after meal consumption

  • Continuous Glucose Monitoring Peak Glucose

    0-180 minutes after meal consumption

  • +5 more secondary outcomes

Other Outcomes (3)

  • Postprandial Plasma Triglycerides

    Baseline and 180 minutes after meal consumption

  • Postprandial Glucagon-Like Peptide-1 (GLP-1) Concentrations

    During the 0-180-minute postprandial period

  • Postprandial Glucose-Dependent Insulinotropic Polypeptide (GIP) Concentrations

    During the 0-180-minute postprandial period

Study Arms (2)

Pistachio Then Control Sequence

EXPERIMENTAL

Participants randomized to this sequence will first complete the pistachio condition, in which 30 g of shelled pistachios are consumed with the standardized high-glycemic breakfast meal. After a 3-7 day washout period, participants will complete the refined-carbohydrate control condition, in which an isocaloric refined-carbohydrate control food is consumed with the same standardized breakfast meal.

Other: Pistachio Co-consumptionOther: Refined-Carbohydrate Control Co-consumption

Control Then Pistachio Sequence

EXPERIMENTAL

Participants randomized to this sequence will first complete the refined-carbohydrate control condition, in which an isocaloric refined-carbohydrate control food is consumed with the standardized high-glycemic breakfast meal. After a 3-7 day washout period, participants will complete the pistachio condition, in which 30 g of shelled pistachios are consumed with the same standardized breakfast meal.

Other: Pistachio Co-consumptionOther: Refined-Carbohydrate Control Co-consumption

Interventions

Participants will consume 30 g of shelled, lightly salted pistachios together with a standardized high-glycemic breakfast meal. The pistachios and standardized breakfast meal will be consumed within a fixed 10-minute meal period.

Control Then Pistachio SequencePistachio Then Control Sequence

Participants will consume an isocaloric refined-carbohydrate control food together with the same standardized high-glycemic breakfast meal. The control food will be matched to the pistachio condition for energy content as closely as possible while providing minimal fiber, protein, unsaturated fat, and bioactive compounds.

Control Then Pistachio SequencePistachio Then Control Sequence

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years, male or female, and able to provide informed consent.
  • BMI ≥25.0 kg/m². Waist circumference and BIA-derived body composition will also be assessed during screening and considered with BMI to help confirm that elevated BMI reflects excess adiposity rather than primarily high muscularity.
  • Weight stable, defined as no intentional weight loss or body weight change \>3 kg during the previous 3 months.
  • Able to complete a 10-12-hour overnight fast and refrain from vigorous exercise and alcohol for 24 hours before each test meal visit.
  • Able and willing to consume pistachios, the refined-carbohydrate control food, and the standardized breakfast meal.

You may not qualify if:

  • Known diagnosis of type 1 or type 2 diabetes. Individuals with known prediabetes will not be excluded.
  • Clinically significant cardiovascular disease, including prior myocardial infarction or stroke, uncontrolled hypertension, clinically significant arrhythmia, or another cardiovascular condition that could make participation unsafe or meaningfully affect study outcomes.
  • Chronic kidney disease or another major medical condition that could make participation unsafe or meaningfully affect metabolic outcomes.
  • Current participation in a weight-loss program, use of weight-loss medications, or history of bariatric surgery within the past year.
  • Known allergy or intolerance to pistachios, tree nuts, peanuts/peanut butter, wheat/gluten, orange juice/citrus, or any other study-meal ingredient.
  • Celiac disease, Crohn's disease, ulcerative colitis, or another clinically significant gastrointestinal or malabsorption condition that could affect digestion, nutrient absorption, or metabolic responses.
  • Current ketogenic, very-low-carbohydrate, or medically prescribed diet that could meaningfully interfere with the standardized feeding protocol or metabolic outcomes.
  • Participation in another clinical research trial within the past 3 months that could affect participant safety or study outcomes.
  • Recent significant illness, infection, or surgery within the past 4 weeks that could affect participant safety or study outcomes.
  • Current or prior clinically significant eating disorder that, in the investigator's judgment, could make participation unsafe or interfere with the feeding protocol.
  • Current smoking, frequent nicotine use, or excessive alcohol use.
  • Pregnancy, planned pregnancy during the study period, or lactation.
  • Any condition or medication that, in the investigator's judgment, would make participation unsafe or interfere with outcome measures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63104, United States

RECRUITING

MeSH Terms

Conditions

ObesityOverweightInsulin Resistance

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Hossein Rafiei, PhD, RD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hossein Rafiei, PhD, RD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 26, 2026

First Posted

October 2, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data are not currently planned to be shared with researchers outside the study team. Study results will be reported in aggregate or de-identified form in accordance with applicable institutional, ethical, and privacy requirements.

Locations