NCT06627868

Brief Summary

A fully functional brown fat helps maintain a healthy weight and decreases the risk of metabolic diseases such as type II diabetes (T2DM). Unfortunately, in human adults, the functionality of brown fat declines with age, and it is one of the reasons for gaining unhealthy weight, particularly around the waistline (central obesity). Currently, scientists do not clearly understand the reasons for the decline in brown fat functionality. It is possible that the decline in the availability of the molecule Nicotinamide Adenine Dinucleotide (NAD+), which is central to several metabolic processes, plays a role in the decline in brown fat metabolism. This project will clarify whether NAD+-based molecular-targeted therapies for the enhancement of whole-body insulin sensitivity and brown fat metabolism will be successful in adult humans, which will eventually be an important target for reducing the development of obesity and its comorbidities such as T2DM.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Nov 2024

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Nov 2024Aug 2027

First Submitted

Initial submission to the registry

October 2, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 20, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

October 2, 2024

Last Update Submit

February 14, 2026

Conditions

Obesity, Abdominal

Outcome Measures

Primary Outcomes (1)

  • Whole-body Insulin Sensitivity

    Whole-body insulin sensitivity measured with hyperinsulinemic, euglycemic clamp technique

    6 months

Secondary Outcomes (1)

  • Brown adipose tissue glucose uptake rate

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Oral NAD+ precursor supplementation

EXPERIMENTAL
Dietary Supplement: NAD+ precursor

Interventions

NAD+ precursorDIETARY_SUPPLEMENT

NAD+ precursor supplementation (Nicotinamide, Nicotinamide Riboside, or Nicotinamide Mononucleotide)

Oral NAD+ precursor supplementation
PlaceboOTHER

Oral placebo daily intake for 6 months

Placebo

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to provide informed consent to participate in the BATNAD study
  • Must be able to read and speak English/Finnish/Swedish well enough to completely understand the instructions and provide informed consent
  • Age 30-55 (sedentary lifestyle)
  • BMI = 18-25 kg/m2 (normal-weight subjects)
  • BMI ≥ 28 kg/m2 and waist circumference more than 100 cm in men and more than 90 cm in women (subjects with obesity)

You may not qualify if:

  • Inability to have PET/CT (claustrophobia, metal implants, recent tattoo including metal components, weight \> 200 kg)
  • Pregnancy and pregnancy related conditions (postpartum/lactation during the last 12 months, or planning to become pregnant soon)
  • Major alterations in the menstrual cycle (e.g., amenorrhea)
  • Use of nicotine based products
  • Hypo- or hyper- thyroidism (medical history, TSH, T3 or T4 levels out of the normal range)
  • Diabetes mellitus (fasting Hb1Ac \>6.5% or fasting glycaemia\> 7.0 mmol/)
  • Abnormal oral glucose tolerance test (2h OGTT \> 11.1 mmol/L)
  • Hypertension (blood pressure \> 160/100 mmHg)
  • Abnormal cardiovascular status (arrhythmia and/or long QTc in ECG, abnormal cardiac murmur, previous history of cardiovascular disease)
  • Abnormal coagulopathy (e.g., clotting abnormality)
  • Malignancies
  • Immunological, autoimmune and primary/secondary immunodeficiency disorders (including or not any active treatment)
  • Virus or bacterial infection (both asymptomatic and symptomatic picture) within the 45 days prior to the study start
  • Vaccination within the 45 days prior to the study start
  • Episode of fever or major surgery, burns and traumas within the month prior to the study start
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, 20520, Finland

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mueez U-Din, PhD

    Turku PET Centre, Turku University Hospital

    PRINCIPAL INVESTIGATOR

  • Kirsi A Virtanen, MD PhD

    University of Turku

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mueez U-Din, PhD

CONTACT

+358-417027723mueez.udin@utu.fi

Kirsi Virtanen, MD, PhD

CONTACT

+358407626564kianvi@utu.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Prof.

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 4, 2024

Study Start

November 20, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)