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Popular Diets Study

22. november 2016 oppdatert av: David S. Ludwig, MD, PhD, Boston Children's Hospital

Popular Diets, Metabolism, and CVD Risk

The aim of this study is to evaluate the effects of three dominant dietary patterns - conventional low-fat, low-glycemic index (GI) and very-low-carbohydrate - on energy metabolism and heart disease risk factors following weight loss in obese young adults in a feeding study

Studieoversikt

Detaljert beskrivelse

For most of the last half century, reduction in fat intake has been the primary nutritional approach for the prevention and treatment of obesity and cardiovascular disease (CVD). Over the last few years, very low carbohydrate (Atkins-type) diets have achieved great popularity, with publication of several studies suggesting greater weight loss and improvements in CVD risk factors over 3 to 6 months. Recently, a third dietary approach focused on glycemic index (GI) has generated interest. However, few studies have compared the effects of these diets on body weight regulation and risk for CVD. The primary hypotheses of this study are that any diet that lowers the postprandial rise in blood glucose (very-low-carbohydrate or low-GI) will have beneficial effects on the physiological adaptations to weight loss and on some CVD risk factors. However, other CVD risk factors will be adversely affected by a very-low-carbohydrate vs. a low-GI diet. Preliminary data provide strong support for these hypotheses, by showing that resting energy expenditure declines less and CVD risk factors improve more with weight loss on a low-glycemic load diet compared to a conventional low-fat diet. This application proposes a cross-over feeding design to study the effects of three diets following 12.5% weight loss in obese young adult subjects (n = 24, age 18 to 40 years). The diets are: 1) conventional low-fat, with 60% carb, 20% fat, 20% protein; 2) low-GI with 40% carb, 40% fat, 20% protein; and 3) very-low-carbohydrate with 10% carb, 60% fat, 30% protein. The primary outcome is resting energy expenditure (indirect calorimetry). Secondary outcomes include total energy expenditure (doubly labeled water), thermic effect of food (indirect calorimetry), physical activity (accelerometry), insulin resistance and B-cell function (frequently-sampled OGTT), blood lipids, blood pressure and measures of systemic inflammation and coagulopathy. This study should have major public health implications to the millions of Americans currently following diets to decrease body weight and risk for heart disease.

Studietype

Intervensjonell

Registrering (Faktiske)

24

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Children's Hospital Boston

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 40 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • BMI ≥ 27 kg/m2
  • Willing and able to come to the GCRC 5 days per week to consume a supervised meal and pick-up food for all other meals
  • Available for scheduled hospital admissions
  • Willing to abstain from alcohol consumption for the duration of the study
  • If female, regular menstrual cycles (defined as 26 to 30 days between cycles; no more than one day variation in the duration of menstrual flow)

Exclusion Criteria:

  • Weight > 350 lbs
  • Change in body weight (± 10%) over preceding year
  • Taking any medications or dietary supplements that might affect body weight, appetite, or energy expenditure
  • Smoking (1 cigarette in the last week)
  • High levels of physical activity
  • Currently following a special diet
  • Abnormal laboratory screening tests
  • Type 2 diabetes mellitus
  • Allergies or aversions to foods on the study menu
  • Previous diagnosis of an eating disorder or any other mental health disorder
  • If female, pregnant in the past 12 months or planning to become pregnant during the study period
  • If female, lactating in the preceding 12 months
  • If taking birth control medication, change in medication in previous 3 months or plans to change medication during the study period

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 2
Diett med lavt fettinnhold
Feeding protocol, all foods prepared in a metabolic kitchen
Eksperimentell: 1
Low glycemic index diet
Feeding protocol, all foods prepared in a metabolic kitchen
Aktiv komparator: 3
Very low carbohydrate diet
Feeding protocol, all foods prepared in a metabolic kitchen

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
resting energy expenditure using indirect calorimetry in the fasting state
Tidsramme: end of each dietary period
end of each dietary period
insulin resistance assessed by frequently-sampled oral glucose tolerance test
Tidsramme: end of each dietary period
end of each dietary period
thyroid function tests
Tidsramme: end of each dietary period
end of each dietary period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
total energy expenditure using doubly labeled water methodology
Tidsramme: end of each dietary period
end of each dietary period
thermic effect of food using indirect calorimetry
Tidsramme: end of each dietary period
end of each dietary period
physical activity using accelerometry
Tidsramme: end of each dietary period
end of each dietary period
serum lipids
Tidsramme: end of each dietary period
end of each dietary period
plasminogen activator inhibitor-1
Tidsramme: end of each dietary period
end of each dietary period
C-reactive protein
Tidsramme: end of each dietary period
end of each dietary period
blood pressure
Tidsramme: end of each dietary period
end of each dietary period
hunger/appetite
Tidsramme: end of each dietary period
end of each dietary period
insulin 30 minutes after oral glucose (as an effect modifier)
Tidsramme: baseline
baseline
Core temperature
Tidsramme: End of each dietary period
End of each dietary period
secreted frizzle-related protein-4
Tidsramme: end of each dietary period
end of each dietary period
heme-oxygenase
Tidsramme: end of each dietary period
end of each dietary period
Irisin
Tidsramme: end of each dietary period
end of each dietary period
fibroblast growth factor-21
Tidsramme: end of each dietary period
end of each dietary period
chemerin
Tidsramme: end of each dietary period
end of each dietary period
trimethylamine N-oxide
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
alanine aminotransferase
Tidsramme: end of each dietary period
end of each dietary period
Uric acid
Tidsramme: end of each dietary period
end of each dietary period
insulin
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
ghrelin
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
gastric inhibitory peptide
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
GLP1
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
PYY
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
Amylin
Tidsramme: fasting and postprandial, end of each dietary period
fasting and postprandial, end of each dietary period
Leptin
Tidsramme: end of each dietary period
end of each dietary period
Metabolomic analysis
Tidsramme: end of each dietary period
Evaluate the effect of diet on metabolomic profile in plasma, with the aim of assessing dietary adherence and exploring diet-disease mechanisms
end of each dietary period

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Cara B Ebbeling, PhD, Boston Children's Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2006

Primær fullføring (Faktiske)

1. juni 2010

Studiet fullført (Faktiske)

1. april 2013

Datoer for studieregistrering

Først innsendt

14. april 2006

Først innsendt som oppfylte QC-kriteriene

14. april 2006

Først lagt ut (Anslag)

18. april 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. november 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. november 2016

Sist bekreftet

1. november 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 1R01DK072428 (U.S. NIH-stipend/kontrakt)
  • R01DK072428 (U.S. NIH-stipend/kontrakt)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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