- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00315354
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
Status
Fullført
Forhold
Intervensjon / Behandling
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
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Children's Hospital Boston
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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
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Feeding protocol, all foods prepared in a metabolic kitchen
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Eksperimentell: 1
Low glycemic index diet
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Feeding protocol, all foods prepared in a metabolic kitchen
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Aktiv komparator: 3
Very low carbohydrate diet
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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
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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
|
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insulin 30 minutes after oral glucose (as an effect modifier)
Tidsramme: baseline
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baseline
|
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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
|
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GLP1
Tidsramme: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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PYY
Tidsramme: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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Amylin
Tidsramme: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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Leptin
Tidsramme: end of each dietary period
|
end of each dietary period
|
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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.
Sponsor
Samarbeidspartnere
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.
Generelle publikasjoner
- Walsh CO, Ebbeling CB, Swain JF, Markowitz RL, Feldman HA, Ludwig DS. Effects of diet composition on postprandial energy availability during weight loss maintenance. PLoS One. 2013;8(3):e58172. doi: 10.1371/journal.pone.0058172. Epub 2013 Mar 6.
- Ebbeling CB, Swain JF, Feldman HA, Wong WW, Hachey DL, Garcia-Lago E, Ludwig DS. Effects of dietary composition on energy expenditure during weight-loss maintenance. JAMA. 2012 Jun 27;307(24):2627-34. doi: 10.1001/jama.2012.6607.
- Hron BM, Ebbeling CB, Feldman HA, Ludwig DS. Hepatic, adipocyte, enteric and pancreatic hormones: response to dietary macronutrient composition and relationship with metabolism. Nutr Metab (Lond). 2017 Jul 5;14:44. doi: 10.1186/s12986-017-0198-y. eCollection 2017.
- Esko T, Hirschhorn JN, Feldman HA, Hsu YH, Deik AA, Clish CB, Ebbeling CB, Ludwig DS. Metabolomic profiles as reliable biomarkers of dietary composition. Am J Clin Nutr. 2017 Mar;105(3):547-554. doi: 10.3945/ajcn.116.144428. Epub 2017 Jan 11. Erratum In: Am J Clin Nutr. 2022 Feb 9;115(2):601.
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
Ytterligere relevante MeSH-vilkår
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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