Open Label Extension Study of NCT06221852

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT06558201
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Ketogenic diet — OTHER
    The ketogenic diet (KD) is a normo-caloric diet composed of high-fat, low carbohydrate, and adequate protein intake. The KD will consist of 3 meals a day plus snacks, targeting 75-80% fat, 13-18% protein, 7% carbohydrates.

Study Details

This is a 12-week open-label extension study for participants completing study NCT06221852.

Key Dates

Start date
Aug 28, 2024
Status verified
Apr 2025
Primary completion
Sep 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ketogenic diet
    Participants will be asked to follow the ketogenic diet (KD) for 12 weeks in addition to any ongoing medications (e.g., mood stabilizers and/or second-generation antipsychotics). Participants will receive diet counseling from a registered dietitian. Participants will be asked to monitor and report their blood ketone and glucose levels each day via a finger-prick device provided by the study team.

Primary Outcome Measure

Change in brain redox nicotinamide adenine dinucleotide metabolites ratio (NAD+/NADH) [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
McLean HospitalBelmontMassachusetts02487-

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