Popular Diets Study
22. November 2016 aktualisiert von: 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
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
24
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02115
- Children's Hospital Boston
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 40 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: 2
Wenig-Fett Diät
|
Feeding protocol, all foods prepared in a metabolic kitchen
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|
Experimental: 1
Low glycemic index diet
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Feeding protocol, all foods prepared in a metabolic kitchen
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Aktiver Komparator: 3
Very low carbohydrate diet
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Feeding protocol, all foods prepared in a metabolic kitchen
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
resting energy expenditure using indirect calorimetry in the fasting state
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
insulin resistance assessed by frequently-sampled oral glucose tolerance test
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
thyroid function tests
Zeitfenster: end of each dietary period
|
end of each dietary period
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
total energy expenditure using doubly labeled water methodology
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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thermic effect of food using indirect calorimetry
Zeitfenster: end of each dietary period
|
end of each dietary period
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|
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physical activity using accelerometry
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
|
serum lipids
Zeitfenster: end of each dietary period
|
end of each dietary period
|
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plasminogen activator inhibitor-1
Zeitfenster: end of each dietary period
|
end of each dietary period
|
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C-reactive protein
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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blood pressure
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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hunger/appetite
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
|
insulin 30 minutes after oral glucose (as an effect modifier)
Zeitfenster: baseline
|
baseline
|
|
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Core temperature
Zeitfenster: End of each dietary period
|
End of each dietary period
|
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secreted frizzle-related protein-4
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
|
heme-oxygenase
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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Irisin
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
|
fibroblast growth factor-21
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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chemerin
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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trimethylamine N-oxide
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
|
alanine aminotransferase
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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Uric acid
Zeitfenster: end of each dietary period
|
end of each dietary period
|
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insulin
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
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ghrelin
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
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gastric inhibitory peptide
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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GLP1
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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PYY
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
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Amylin
Zeitfenster: fasting and postprandial, end of each dietary period
|
fasting and postprandial, end of each dietary period
|
|
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Leptin
Zeitfenster: end of each dietary period
|
end of each dietary period
|
|
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Metabolomic analysis
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Cara B Ebbeling, PhD, Boston Children's Hospital
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2006
Primärer Abschluss (Tatsächlich)
1. Juni 2010
Studienabschluss (Tatsächlich)
1. April 2013
Studienanmeldedaten
Zuerst eingereicht
14. April 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. April 2006
Zuerst gepostet (Schätzen)
18. April 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
23. November 2016
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. November 2016
Zuletzt verifiziert
1. November 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1R01DK072428 (US NIH Stipendium/Vertrag)
- R01DK072428 (US NIH Stipendium/Vertrag)
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