NCT05028803

Brief Summary

The aim of this study is to reduce fasting circulating BCAA concentrations in volunteers using Sodium Phenylbutyrate. In addition, we aim investigate the effect of BCAA lowering on fasting blood glucose levels, insulin sensitivity measures and muscle metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 28, 2026

Status Verified

March 1, 2025

Enrollment Period

2 years

First QC Date

August 25, 2021

Last Update Submit

April 27, 2026

Conditions

Obese Non Diabetic

Outcome Measures

Primary Outcomes (1)

  • Serum branched chain amino acids (BCAA) levels

    Both total and individual BCAAs before and after intervention

    3 weeks

Secondary Outcomes (2)

  • Musle protein syntyhesis (MPS)

    4 weeks

  • Metabolic status (Oral glucose tolerance testing (OGTT))

    3 weeks

Other Outcomes (3)

  • Glycated haemoglobin (Hba1c) glucose metabalism testing via venepuncture

    3 weeks

  • Fructosamine glucose metabalism testing via venepuncture

    3 weeks

  • Immune statis (full blood count via venepuncture)

    3 weeks

Study Arms (1)

Phenylbutyrate

EXPERIMENTAL

Volunteers will recieve 5 grams of Sodium Phenylbutyrate daily for 3 weeks (21 days). Sodium Pheburane will come in granuale form and 5 grams will be dosed every day.

Drug: sodium phenylbutyrate

Interventions

sodium phenylbutyrateDRUG

same as arm/group

Phenylbutyrate

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study
  • Not currently taking any medications
  • Males between the ages of 18 - 60
  • BMI ≥ 30 kg·m2
  • FBG ≥ 6 mmol/L ≤ 7mmol/L or HbA1c ≥ 42 mmol/mol 48 ≤ mmol/mol

You may not qualify if:

  • Specify any diseases/disorders/ conditions that would preclude entry into the study
  • Females
  • History or current psychiatric illness
  • History or current neurological condition (e.g. epilepsy)
  • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (this must remain for ALL UoN FMHS UREC approved studies)
  • A BMI \< 30kg·m2
  • FBG \>7mmol/L/ or HbA1c \>48mmol/mol
  • Metabolic disease; Active inflammatory bowel disease
  • Chronic kidney disease
  • Malignancy
  • Recent (6 mo) steroid/ hormone therapy
  • Clotting dysfunction
  • Musculoskeletal/ neurological disorders
  • Active cardiovascular disease or recent cardiac event
  • Respiratory disease (not including well-controlled asthma)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Derby, Derbyshire, DE22 3NE, United Kingdom

Location

MeSH Terms

Interventions

4-phenylbutyric acid

Study Officials

  • Philip Prof Athertone, DM

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Philip athertone

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 31, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2023

Study Completion

March 1, 2024

Last Updated

April 28, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Individual participant medical information obtained as a result of this study are considered confidential and disclosure to third parties is prohibited with the exceptions noted above. Such medical information may be given to the participant's medical team and all appropriate medical personnel responsible for the participant's welfare. If information is disclosed during the study that could pose a risk of harm to the participant or others, the researcher will discuss this with the Chief Investigator (CI) and where appropriate report accordingly. Data generated as a result of this trial will be available for inspection on request by the participating physicians, the University of Nottingham representatives, the local Research Ethics Committee (REC) and the regulatory authorities. Elements of the results from this study will be submitted for peer-review in at least one publication.

Locations

GB(1)