AIM-TEST: Microbiome-Targeted Nutrition for Functional Secondary Hypogonadism

Summary

AIM-TEST is a randomized, double-blind, placebo-controlled clinical trial evaluating whether an AI-guided, microbiome-targeted nutritional intervention can increase the body's own testosterone production in men aged 30-65 years with symptomatic, biochemically confirmed functional secondary hypogonadism.

Functional secondary hypogonadism is characterized by symptoms of testosterone deficiency together with repeatedly low morning testosterone levels and low or inappropriately normal gonadotropin levels, without evidence of primary testicular failure or an organic hypothalamic or pituitary disorder. Men may be included regardless of their body weight or obesity status, provided that their low testosterone has been appropriately confirmed and does not require urgent disease-specific or hormonal treatment.

Participants will be randomly assigned to receive either the active nutritional supplement or a matched placebo once daily for 12 weeks. The main question is whether the active intervention produces a greater increase in morning total testosterone than placebo. The study will also assess calculated free testosterone, symptoms of androgen deficiency, sexual function, metabolic and inflammatory markers, gut microbiome changes, treatment tolerability, and safety. Participants will be followed for an additional 12 weeks after stopping the study product to explore whether any observed effects are maintained.

The study hypothesis is that the microbiome-targeted intervention will result in a greater improvement in endogenous testosterone levels than placebo. This is a proof-of-concept study and is not intended to replace standard diagnostic evaluation or established treatment when these are clinically required.

Conditions

• Hypogonadism, Male
• Secondary Hypogonadism

Interventions

DIETARY_SUPPLEMENT

Fixed-Formula Microbiome-Targeted Oral Nutritional Supplement

A fixed-formula, microbiome-targeted oral nutritional supplement administered as one sachet and one capsule once daily for 12 weeks. The formulation was developed through an AI-guided evaluation of microbiome-related biological pathways and candidate nutritional components. All participants assigned to the experimental arm will receive the same standardized formulation; the intervention will not be personalized or modified according to individual microbiome findings during the study. The 12-week intervention period will be followed by a 12-week period without study product. The complete qualitative and quantitative formulation, ingredient standardization, manufacturing specifications, and storage conditions will be defined in the final approved product specification.

DIETARY_SUPPLEMENT

Matched Oral Placebo

A matched placebo administered as one sachet and one capsule once daily for 12 weeks, followed by a 12-week period without study product. The placebo will be matched as closely as feasible to the active intervention in packaging, appearance, weight, taste, odor, mouthfeel, and administration schedule. It will not contain the active prebiotic, postbiotic, botanical, mineral, or other functional ingredients included in the experimental formulation and will be designed not to meaningfully affect testosterone regulation, the gut microbiome, or the principal hormonal and metabolic study outcomes. The final composition and manufacturing specifications will be documented in the approved placebo specification.

Sponsors & Collaborators

• Izmir City Hospital

  collaborator OTHER_GOV

• Aydin Adnan Menderes University

  collaborator OTHER

• Varol TUNALI

  lead INDUSTRY

Principal Investigators

• Varol TUNALI, Dr. · Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore Facoltà di Medicina e Chirurgia, Roma, Italy;

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-15

Primary Completion

2027-03-30

Completion

2027-06-30

Countries

• Turkey (Türkiye)

Study Locations