- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01050140
The Metabolic Effects of a High Fructose Versus a High Glucose Diet in Overweight Men
Dietary consumption of fructose has increased by nearly 50% since 1960.
A high fructose diet (HFrD) results in greater visceral adiposity and systemic insulin resistance than a high glucose diet. The effects of fructose on liver fatty acid and ATP stores, systemic oxidative stress and cardiovascular status are not fully known.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The protocol will assess the following outcomes:
- The ultimate fate of this increased hepatic fatty acid production following a high fructose vs. glucose diet
- The effect of a high fructose vs. glucose diet on liver ATP stores
- The effect of a high fructose vs. glucose diet on markers of oxidative stress
- The effect of a high fructose vs. glucose diet on cardiovascular status
Factors critical to carbohydrate metabolism such as systemic insulin resistance, body composition, energy expenditure, physical activity will also be assessed.
32 centrally overweight healthy males with a low baseline fructose intake will be recruited. They will be randomised double blindly to receive 25% of their dietary energy requirements from either fructose or glucose for 14 days.
The sugars will first be taken in an energy balanced and then an overfeeding setting.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, Det Forenede Kongerige, NG7 2UH
- School of Biomedical Sciences, University of Nottingham
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Body mass index 25-32
- Waist > hip circumference
- Age 18-50 years
- Male
Exclusion Criteria:
- Reported weight change > 3 kg in prior 3/12
- Active health problems
- Contraindications to MRI scanning
- Symptoms of functional bloating or irritable bowel syndrome
- Abnormal liver or renal function tests
- Random glucose greater than 11.0 mmol/L
- Evidence of metabolic or viral liver disease as screened for by hepatitis B and C serology, and ferritin.
- Alcohol intake > 21 units per week
- Vegetarianism
- Normal daily fructose intake from drinks greater than that in 500ml of coca cola
- Abnormal carbohydrate energy contribution to baseline diet - defined as greater than 2 standard deviations from the mean of the National Diet and Nutrition Survey 2002 data
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: fructose
25% dietary energy from fructose
|
25% of dietary energy from fructose or glucose
|
|
Aktiv komparator: glucose
25% dietary energy from glucose
|
25% of dietary energy from fructose or glucose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Liver triglyceride content
Tidsramme: 2 weeks
|
2 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Muscle triglyceride content
Tidsramme: 2 weeks
|
2 weeks
|
|
Total abdominal visceral fat content (MRI)
Tidsramme: 2 weeks
|
2 weeks
|
|
Liver ATP, PME concentration and pH (31P MRS)
Tidsramme: 2 weeks
|
2 weeks
|
|
Liver de novo lipogenesis
Tidsramme: 2 weeks
|
2 weeks
|
|
Resting energy expenditure, lipid and carbohydrate oxidation rates
Tidsramme: 2 weeks
|
2 weeks
|
|
Hepatic and systemic insulin resistance
Tidsramme: 2 weeks
|
2 weeks
|
|
Cardiovascular measures using finometry
Tidsramme: 2 weeks
|
2 weeks
|
|
Systemic oxidative stress and inflammatory cytokine profile
Tidsramme: 2 weeks
|
2 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Ian A Macdonald, PhD, School of Biomedical Sciences, Nottingham University, UK
- Ledende efterforsker: Richard D Johnston, MRCP, School of Biomedical Sciences, Nottingham University, UK
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D/10/2009
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