Paleolithic Diets vs T2D and Improvements in the Metabolic Syndrome
Paleolithic Diets and Metabolic Control in Type 2 Diabetes Mellitus
This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology.
We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study proposes to evaluate the physiological effects of eating Paleolithic type diet ("hunter-gatherer's diet") on Type 2 diabetic patients. The diet essentially consists of fruits, vegetables, nuts, lean meats, excludes dairy products and grains.Subjects will be randomized into taking either ADA (American Diabetic Association) recommended diet or Paleolithic diet for 21 days. The research kitchen will provide all food items and total calories in both groups will be adjusted to maintain baseline weight. Blood and urine test will be done in the first 3 days, last 3 days and 1 month after the study period to study and compare the effects of the two diets on subjects glucose control, lipid profile and other parameters of cardiovascular physiology.
We hypothesize that a palaeolithic diet in subjects with Type 2 diabetes mellitis, will result in improvement in above parameters and lead to improvement in glucose control with less need for diabetes medicines (either lower doses or fewer medications) to a greater extent than in subjects fed with ADA diet, without any change in weight. We also expect a beneficial effect on blood vessel function, lipid profiles and blood pressure.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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San Francisco, California, Verenigde Staten, 94143
- University of California San Francisco
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Type 2 diabetic patients
- Age >= 18 yrs
- BMI < 40 kg/m2
- Normal cardiac, renal and hepatic function
Exclusion Criteria:
- Subjects on thiazolidinediones ( Avandia, Actos) or other medications that interfere with the testing procedures
- Subjects unwilling or unable to follow the diet specified
- Pregnant women
- Subjects who are unable to understand the consent form
- Hematocrit less than 30
- Patients with defibrillators
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: A
Subjects will be placed on Paleolithic diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
a paleolithic diet excludes dairy, grains, legumes and processed foods.
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diet
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Actieve vergelijker: B
Subjects will be placed on ADA ( American Diabetes Association) recommended diet and markers of insulin resistance, lipid profiles and vascular reactivity will be measured.
An ADA diet is lower fat and more whole grains.
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diet
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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decreased insulin secretion
Tijdsspanne: 2 months
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2 months
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: lynda frassetto, md, University of California, San Francisco
- Hoofdonderzoeker: Franca Angeli, MD, University of California, San Francisco
- Hoofdonderzoeker: Umesh Masharani, MRCP, University of California, San Francisco
- Studie directeur: Shelley MCCoy, University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H84763129001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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