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Popular Diets Study

22. november 2016 opdateret af: 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

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children's Hospital Boston

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 2
Fedtfattig kost
Feeding protocol, all foods prepared in a metabolic kitchen
Eksperimentel: 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

Hvad måler undersøgelsen?

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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2006

Primær færdiggørelse (Faktiske)

1. juni 2010

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

14. april 2006

Først indsendt, der opfyldte QC-kriterier

14. april 2006

Først opslået (Skøn)

18. april 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. november 2016

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

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

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