NCT02456870

Brief Summary

The purpose of this pilot study is to determine whether adipose tissue loses some of its ability to expand in response to overfeeding in older compared to younger men. The investigators hypothesize that the adipose tissue response to overfeeding may be weakened in older when compared to younger men, thereby leading to worsened ectopic storage depots for older men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

April 8, 2015

Last Update Submit

June 11, 2019

Conditions

AgingObesity

Keywords

Adipose tissueOverfeeding

Outcome Measures

Primary Outcomes (1)

  • Change in adipose-derived stem cell (ASC) differentiation (Delta%oil red O+)

    age-related difference in the ASC differentiation response to overfeeding

    1 wk of overfeeding

Secondary Outcomes (3)

  • Change in ASC proliferation (Delta rate of cell growth)

    1 wk of overfeeding

  • Change in expression of C/EBPalpha, C/EBPbeta, PPARgamma2, SREBP1c, SREBf1a, and Wnt10b (fold-changes in mRNA expression)

    1 wk overfeeding

  • Change in intramyocellular (IMCL) di-saturated diacylglycerol (DAG) localization (Delta %membrane:cytosol)

    1 week overfeeding

Study Arms (2)

MA

OTHER

Middle-aged overweight and obese men (age 25-40yr)

Other: Overfeeding

OA

OTHER

Older overweight and obese men (age 55-75yr)

Other: Overfeeding

Interventions

OverfeedingOTHER

Consumption of 40% excess calories for 7 consecutive days

MAOA

Eligibility Criteria

Age25 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men
  • Aged 25-40y OR 55-75y
  • BMI 28-35 kg/m2
  • Weight stable (±2kg over past 3 mo)
  • Sedentary to moderately active (\<3 d/wk of exercise lasting \>20min)
  • Non-smokers (never used or quit \>7yrs prior)

You may not qualify if:

  • Women
  • Currently using hormones, glucose or lipid lowering medication
  • Engaged in exercise or diet program
  • Currently gaining or losing weight or using weight loss drugs
  • Diabetes mellitus (diagnosis, treatment, FBG ≥126 mg/dL)
  • Uncontrolled metabolic disorders (e.g., thyroid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

  • Kim JY, van de Wall E, Laplante M, Azzara A, Trujillo ME, Hofmann SM, Schraw T, Durand JL, Li H, Li G, Jelicks LA, Mehler MF, Hui DY, Deshaies Y, Shulman GI, Schwartz GJ, Scherer PE. Obesity-associated improvements in metabolic profile through expansion of adipose tissue. J Clin Invest. 2007 Sep;117(9):2621-37. doi: 10.1172/JCI31021.

    PMID: 17717599BACKGROUND

  • Caso G, McNurlan MA, Mileva I, Zemlyak A, Mynarcik DC, Gelato MC. Peripheral fat loss and decline in adipogenesis in older humans. Metabolism. 2013 Mar;62(3):337-40. doi: 10.1016/j.metabol.2012.08.007. Epub 2012 Sep 19.

    PMID: 22999012BACKGROUND

  • Tchoukalova YD, Votruba SB, Tchkonia T, Giorgadze N, Kirkland JL, Jensen MD. Regional differences in cellular mechanisms of adipose tissue gain with overfeeding. Proc Natl Acad Sci U S A. 2010 Oct 19;107(42):18226-31. doi: 10.1073/pnas.1005259107. Epub 2010 Oct 4.

    PMID: 20921416BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rachael E Van Pelt, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2015

First Posted

May 29, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

US(1)