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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 maggio 2016 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Sovrappeso

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

Fase

Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Danimarca
- Frederiksberg
  - Copenhagen, Frederiksberg, Danimarca, 1958
    - Department of Nutrition, Exercise and Sports

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 50 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Prevenzione
Assegnazione: Randomizzato
Modello interventistico: Assegnazione incrociata
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: 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: Meat balls with salmon served with tomato sauce and other accompaniments with low GI Meat balls with salmon served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI	Altro: Fish and carbohydrats with low or high GI Altro: Veal and carbohydrats with low or high GI
Sperimentale: 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: Meat balls with codfish served with tomato sauce and other accompaniments with low GI Meat balls with codfish served with tomato sauce and other accompaniments with high GI Meat balls with veal served with tomato sauce and other accompaniments with low GI Meat balls with veal served with tomato sauce and other accompaniments with high GI	Altro: Fish and carbohydrats with low or high GI Altro: Veal and carbohydrats with low or high GI

Gruppo di partecipanti / Arm

Intervento / Trattamento

Sperimentale: 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:

Meat balls with salmon served with tomato sauce and other accompaniments with low GI
Meat balls with salmon served with tomato sauce and other accompaniments with high GI
Meat balls with veal served with tomato sauce and other accompaniments with low GI
Meat balls with veal served with tomato sauce and other accompaniments with high GI

Altro: Fish and carbohydrats with low or high GI

Altro: Veal and carbohydrats with low or high GI

Sperimentale: 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:

Meat balls with codfish served with tomato sauce and other accompaniments with low GI
Meat balls with codfish served with tomato sauce and other accompaniments with high GI
Meat balls with veal served with tomato sauce and other accompaniments with low GI
Meat balls with veal served with tomato sauce and other accompaniments with high GI

Altro: Fish and carbohydrats with low or high GI

Altro: Veal and carbohydrats with low or high GI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Differences in diet induced thermogenesis between the four test meals Lasso di tempo: 3 hours	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.	3 hours

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Satiety Lasso di tempo: 3 hours	Evaluated by VAS-measures of subjective appetite sensations (satiety, hunger, fullness and prospective food consumption)	3 hours
Food preferences Lasso di tempo: 3 hours	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.	3 hours
Glucose Lasso di tempo: 3 hours	Blood sample	3 hours
Insulin Lasso di tempo: 3 hours	Blood sample	3 hours
Glucagon Lasso di tempo: 3 hours	Blood sample	3 hours
C-peptide Lasso di tempo: 3 hours	Blood sample	3 hours
Plasma amino acids Lasso di tempo: 3 hours	Blood samples	3 hours
Appetite regulating hormones Lasso di tempo: 3 hours	e.g. glucagon-like peptide-1 (GLP-1)	3 hours
Free fatty acids Lasso di tempo: 3 hours	Blood sample	3 hours
Glycerol Lasso di tempo: 3 hours	Blood sample	3 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Copenhagen

Collaboratori

The Fisheries and Aquaculture Industry Research Fund

National Institute of Nutrition and Seafood Research, Norway

Investigatori

Investigatore principale: Anne Raben, Prof, Prof at the department of Nutrition, Exercise and Sports

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2014

Completamento primario (Effettivo)

1 gennaio 2016

Completamento dello studio (Effettivo)

1 gennaio 2016

Date di iscrizione allo studio

Primo inviato

29 ottobre 2014

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2016

Primo Inserito (Stima)

12 maggio 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 maggio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 maggio 2016

Ultimo verificato

1 maggio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

H-1-2014-038 (B314)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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)