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Effect of Age and Weight Loss on Inflammation and Iron Homeostasis (HEP)

12 november 2015 uppdaterad av: Simin Meydani, Tufts University

Effect of Age and Weight Loss on Obesity-related Inflammation and Iron Homeostasis in Women

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Obese individuals have chronic inflammation, higher risk of iron deficiency, and impaired immune response. These are conditions seen also with aging, but it is unknown to what extent they may be further impacted by obesity in the elderly. With this study the investigators aim to establish the mechanism by which weight loss may reduce inflammation and enhance iron status in young and older obese adults through the peptide hormone hepcidin, which regulates iron homeostasis. The investigators also aim to identify a possible link between iron homeostasis and immune response through hepcidin, which has been implicated in T cell mediated immunity. The investigators hypothesize that obesity-induced inflammation causes dysregulation of hepcidin expression leading to lower iron status through decreased iron absorption and availability in young and older adults. Furthermore, the investigators hypothesize that hepcidin dysregulation, and thus iron status can be mitigated with weight loss in both young and older obese adults. This hypothesis will be tested in obese young and older women undergoing weight loss through calorie restriction. Change in iron status, inflammation, and hepcidin will be determined before and after weight loss. Further, the impact of inflammatory environment of obesity on peripheral blood mononuclear cell hepcidin, ferroportin, intracellular iron, and T cell function in young and older adults will be determined. This study will address two important public health problems, i.e. obesity and iron deficiency and will be an important step toward the identification of strategies to enhance health of obese young and older adults.

Studietyp

Interventionell

Inskrivning (Faktisk)

44

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02111
        • JM USDA Human Nutrition Research Center on Aging

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Unwilling to discontinue iron supplement intake. The dietary plan recommended by the WWC will include daily intake of iron that meets the iron RDA for the subject's gender and age group, therefore discontinuing iron supplement will not be harmful for the participants. Intake of other supplements will not be an exclusion criteria, as long as it stays constant throughout the study period.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Young (18-45 years)
Obese young women (18-45y) undergoing calorie restriction.
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
Experimentell: Older (>60 years)
Obese older women (>60y) undergoing calorie restriction.
Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in serum hepcidin
Tidsram: Baseline and 12-16 weeks
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)
Tidsram: Baseline and 12-16 weeks
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
Tidsram: Baseline and 12-16 weeks
The investigators will determine the change in iron status at baseline and after 12-16 weeks of calorie restriction.
Baseline and 12-16 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in PBMC intracellular iron content
Tidsram: Baseline and 12-16 weeks
Baseline and 12-16 weeks
Change in PBMC Hepcidin expression
Tidsram: Baseline and 12-16 weeks
Baseline and 12-16 weeks
Change in PBMC ferroportin expression
Tidsram: Baseline and 12-16 weeks
Baseline and 12-16 weeks
Change in PBMC subpopulations and proliferation
Tidsram: Baseline and 12-16 weeks
After stimulation with ConA, PHA and anti-CD3/CD28
Baseline and 12-16 weeks

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Simin N Meydani, DVM, PhD, Tufts University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2011

Primärt slutförande (Faktisk)

1 november 2013

Avslutad studie (Faktisk)

1 november 2013

Studieregistreringsdatum

Först inskickad

26 januari 2012

Först inskickad som uppfyllde QC-kriterierna

5 juli 2012

Första postat (Uppskatta)

10 juli 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 november 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 november 2015

Senast verifierad

1 november 2015

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Fetma

Kliniska prövningar på Calorie Restriction

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