Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism: a Randomized, 4-condition, Two Cross-over Study in Adults. (FINS)
17 maj 2016 uppdaterad av: Anne Birgitte Raben, University of Copenhagen
Acute Effects of Different Protein Sources and Different Glycemic Index on Energy Balance, Glucose Allostasis and Amino Acid Metabolism.
The hypothesis is that seafood proteins given in combination with carbohydrates with low GI are superior to seafood proteins in combination with carbohydrates with high GI and meat in combination with both carbohydrates with low and high GI in promoting energy expenditure and satiety.
The overall objective of this study is to investigate the acute effects of meals containing fish versus meat proteins on energy balance (thermogenesis, appetite regulating hormones and appetite sensations), markers of glucose allostatis and amino acid metabolism.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Frederiksberg
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Copenhagen, Frederiksberg, Danmark, 1958
- Department of Nutrition, Exercise and Sports
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Healthy men and women
- Between 18 and 50 years of age
- BMI between 25.0 and 30.0 kg×m-2
- Fasting blood glucose < 5.9 mmol/L (measured at the screenings visit)
- Non-smoker
Exclusion Criteria:
- Self-reported eating disorders or irregular eating schedule (e.g. skipping breakfast)
- Chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, neurological disorders, or sleep disorders)
- Use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed), psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months.
- Women who are pregnant, breast-feeding or have intention of becoming pregnant during the study period
- Menopausal women and women with an irregular menstrual cycle
- Food allergies
- Substance abuse
- Vigorous physical activity more than 10 hours/week
- Alcohol intake above the recommendations from the Danish Health and Medicines Authority
- Caffeine intake above 300 mg/day
- Night- or shift work
- Blood donation <1 month before study commencement and during study period
- Simultaneous participation in other clinical studies
- Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff
- Subject's general condition contraindicates continuing the study, as judged by the study personnel or the medical expert
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Salmon vs. veal and CHO with low or high GI
In the first clinical study (Study 1), subjects will eat salmon or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals:
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Experimentell: Cod vs. veal and CHO with low or high GI
In the second clinical study (Study 2), subjects will eat codfish or veal combined with high or low GI carbohydrates. Each subject will be engaged in each of the following four 1-day test meals:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Differences in diet induced thermogenesis between the four test meals
Tidsram: 3 hours
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In the following three hours after eating the test meal respiratory gas exchange will be measured 6x25 minutes with 5 minutes breaks in between each measurement.
Diet induced thermogenesis (DIT) will be measured by indirect calorimetry using a ventilated hood system.
Each measurement will last for 25 minutes of which the last 20 minutes will be used for calculation of energy expenditure.
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3 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Satiety
Tidsram: 3 hours
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Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)
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3 hours
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Food preferences
Tidsram: 3 hours
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In an attempt to measure spontaneous energy intake and macronutrient preferences in an experimental context, the participants will be given an ad libitum buffet lunch at noon.
A cold and hot buffet-style lunch comprising a variety of foods (representing a wide selection of food groups) will be offered after the last measurement of gas exchange and the participants will be instructed to eat ad libitum.
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3 hours
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Glucose
Tidsram: 3 hours
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Blood sample
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3 hours
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Insulin
Tidsram: 3 hours
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Blood sample
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3 hours
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Glucagon
Tidsram: 3 hours
|
Blood sample
|
3 hours
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C-peptide
Tidsram: 3 hours
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Blood sample
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3 hours
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Plasma amino acids
Tidsram: 3 hours
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Blood samples
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3 hours
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Appetite regulating hormones
Tidsram: 3 hours
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e.g.
glucagon-like peptide-1 (GLP-1)
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3 hours
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Free fatty acids
Tidsram: 3 hours
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Blood sample
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3 hours
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Glycerol
Tidsram: 3 hours
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Blood sample
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3 hours
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Anne Raben, Prof, Prof at the department of Nutrition, Exercise and Sports
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2014
Primärt slutförande (Faktisk)
1 januari 2016
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
29 oktober 2014
Först inskickad som uppfyllde QC-kriterierna
11 maj 2016
Första postat (Uppskatta)
12 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
18 maj 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2016
Senast verifierad
1 maj 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-1-2014-038 (B314)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .