NCT01974778

Brief Summary

Brown adipose (fat) tissue (BAT) is a type of fat tissue found in certain small rodents and human babies that is capable of extremely high rates of energy burning. We now know that in adult humans it is present and also able to burn energy. In addition to increased energy expenditure during cold exposure, energy burning is also increased after consuming a meal. Animal studies have shown that part of this additional energy consumption is contributed by BAT. In the present study we will aim to examine whether BAT activity is increased after a meal.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

1.4 years

First QC Date

October 23, 2013

Last Update Submit

January 13, 2016

Conditions

ObesityDiabetesCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • BAT activity

    Analysis of PET/CT scans

    2 years

Study Arms (2)

Active

EXPERIMENTAL

Meal

Dietary Supplement: Meal

Control

PLACEBO COMPARATOR

Water

Dietary Supplement: Meal

Interventions

MealDIETARY_SUPPLEMENT

Meal

ActiveControl

Eligibility Criteria

Age19 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males aged 19 - 35 years
  • Unmedicated for the previous 2 months
  • No major illness
  • BMI 17-40 kg/m2

You may not qualify if:

  • Unable to give informed consent
  • Smokers
  • Participant in research projects involving ionising radiation within the past 5 years, excluding dual energy x-ray absorptiometry scans conducted in prior studies
  • Claustrophobia
  • Fasting plasma glucose \> 6.0 mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

ObesityDiabetes MellitusCardiovascular Diseases

Interventions

Meals

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bronwyn Kingwell, Professor

    Baker IDI Heart & Diabetes Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

October 23, 2013

First Posted

November 4, 2013

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 15, 2016

Record last verified: 2016-01

Locations

AU(1)