NCT01636635

Brief Summary

The purpose of this study is to evaluate the effect of aging and weight loss on iron status and immune response in obese women. Iron deficiency and immune impairment are two of the numerous complications of obesity. The central hypothesis is that obesity-induced inflammation causes lower iron status through decreased iron absorption and availability in young and older obese women. Furthermore, the investigators hypothesize that this can be corrected with weight loss in both young and older obese women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable obesity

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

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

2.7 years

First QC Date

January 26, 2012

Last Update Submit

November 12, 2015

Conditions

ObesityAging

Outcome Measures

Primary Outcomes (3)

  • Change in serum hepcidin

    The investigators will determine the change in hepcidin at baseline and after 12-16 weeks of calorie restriction.

    Baseline and 12-16 weeks

  • Change in inflammation (CRP, IL-6)

    The investigators will determine the change in inflammation at baseline and after 12-16 weeks of calorie restriction.

    Baseline and 12-16 weeks

  • Change in iron status

    The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.

    Baseline and 12-16 weeks

Secondary Outcomes (4)

  • Change in PBMC intracellular iron content

    Baseline and 12-16 weeks

  • Change in PBMC Hepcidin expression

    Baseline and 12-16 weeks

  • Change in PBMC ferroportin expression

    Baseline and 12-16 weeks

  • Change in PBMC subpopulations and proliferation

    Baseline and 12-16 weeks

Study Arms (2)

Young (18-45 years)

ACTIVE COMPARATOR

Obese young women (18-45y) undergoing calorie restriction.

Other: Calorie Restriction

Older (>60 years)

EXPERIMENTAL

Obese older women (\>60y) undergoing calorie restriction.

Other: Calorie Restriction

Interventions

Calorie RestrictionOTHER

Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University

Older (>60 years)Young (18-45 years)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolling patients in the Weight and Wellness Center (WWC) at Tufts Medical Center, part of their Tufts Employees, low calorie diet (LCD) or pre-surgical low calorie diet (PS-LCD) program, or enrolling at WWC as individual patients.
  • BMI in the range of 30 to 55 kg/m2.
  • Either ages 18-45 or \>60.

You may not qualify if:

  • Pregnancy.
  • Weight reduction greater than or equal to 3% in the past 3 months.
  • Prior gastric restrictive surgery.
  • Weight loss medications within the 4 weeks prior to screening.
  • History of eating disorder.
  • Renal disease (serum creatinine \>2mg/dl).
  • Hepatic disease, except for nonalcoholic steatohepatitis (NASH).
  • Celiac disease, or any kind of intestinal malabsorption disorders.
  • Gastrointestinal cancer.
  • Hereditary hemochromatosis, or any blood disorders.
  • Chronic infectious or inflammatory disease.
  • Use of immunosuppressants.
  • Severe iron deficiency anemia (hemoglobin\<8 g/dl) or other conditions that would prevent them from discontinuing iron supplement use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JM USDA Human Nutrition Research Center on Aging

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Simin N Meydani, DVM, PhD

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Simin Meydani, DVM, PhD

Study Record Dates

First Submitted

January 26, 2012

First Posted

July 10, 2012

Study Start

March 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

US(1)