NCT07496320

Brief Summary

Double-blind cross-over intervention where the volunteers were randomized into two groups who, after receiving nutritional counseling, received two formulations in the form of a cookie: Group 1, commercial formulation and Group 2, a C. quinoa-based formulation for 12 days. Volunteers received nutritional advice and did not undergo dietary limitation(s) along the study periods. After the first period, volunteers underwent a washout stage before being included in the group to receive the opposite treatment to that received in the first stage. Blood and fecal samples were taken at both initial (i.e., visit 1, visit V3) and final (visit V2, visit 4) check-up visits from the volunteers at each study period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

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 23, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 23, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

December 4, 2025

Last Update Submit

March 23, 2026

Conditions

Immunological StatusHealthy VolunteersHealthy Volunteers - Male and Female

Keywords

Immunonutritioninnate lymphoid cellsmonocytestriglyceridesinsulinHDLApo_A

Outcome Measures

Primary Outcomes (4)

  • Blood levels of triglycerides

    Influence of the formulation(s) to preserve the peripheral physiological level of triglycerides (below 150 mg/dL)

    Twelve days

  • Blood levels of cholesterol_LDL

    Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol\_LDL (below 100 mg/dL)

    Twelve days

  • Blood levels of insulin

    Influence of the formulations to preserve the peripheral physiological level of insulin (fasting insulin between 2.6 - 24.9 µIU/mL)

    Twelve days

  • Blood levels of cholesterol_HDL

    Influence of the formulation(s) to preserve the peripheral physiological levels of Cholesterol\_HDL (between 40-60 mg/dL)

    Twelve days

Secondary Outcomes (6)

  • Peripheral blood monocytes

    Twelve days

  • Safety and tolerance

    Twelve days

  • Antropometry

    Twelve days

  • Blood levels of glucose

    Twelve days

  • Blood concentration of innate lymphoid cell precursors

    Twelve days

  • +1 more secondary outcomes

Study Arms (2)

Immunonutritional_1

ACTIVE COMPARATOR

Volunteers receive a commercial formulation as positive control of the effect

Dietary Supplement: Administration of a commercial cookie formulationDietary Supplement: Immunonutritional_2

Immunonutritional_2

ACTIVE COMPARATOR

Patients receive a novel formulation to compare the effects in the level of biomarkers

Dietary Supplement: Administration of a commercial cookie formulationDietary Supplement: Immunonutritional_2

Interventions

Administration of a commercial cookie formulationDIETARY_SUPPLEMENT

Volunteers received two cookies - 1st a commercial formulation and 2nd a novel formulation

Immunonutritional_1Immunonutritional_2
Immunonutritional_2DIETARY_SUPPLEMENT

Volunteers receive two cookies - 1st a novel formulation and 2nd a commercial formulation

Immunonutritional_1Immunonutritional_2

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy status,
  • Understanding of the objectives
  • Accep to consume cookies

You may not qualify if:

  • Pregnant, breastfeeding, decreased cognition function, pharmacological treatment
  • Individuals with or who had suffered cardiovascular, hepatic, renal, or inflammatory disease
  • Refuse to consume the cookies, had allergy/intolerance to any of the components of the product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMDEA Nutrition

Madrid, Madrid, 28049, Spain

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

December 4, 2025

First Posted

March 27, 2026

Study Start

October 23, 2024

Primary Completion

October 23, 2024

Study Completion

October 23, 2024

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Confidentiality

Locations

ES(1)