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Acute Responses to Manipulating Dietary Carbohydrate Content on Free-living Physical Activity Energy Expenditure

2. mai 2022 oppdatert av: Javier Gonzalez, University of Bath

Dietary sugar and carbohydrate intakes will be manipulated for 3 days in a randomised crossover design. All food will be provided. Free-living physical activity energy expenditure will be measured using combined heart rate and accelerometry. Metabolic and appetite/mood responses to 3 days on each diet will be measured.

Each participant will undergo 3 days of each diet:

  1. Moderate sugar - reflecting the composition of a typical European diet
  2. Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
  3. Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Guidelines calling for dietary free sugars to be reduced have been formulated from evidence that diets high in sugar are associated with high energy intake. In theory, by reducing the intake of sugars, calorie surplus will be reduced and energy balance will be maintained. However, when referring to interventions/behaviours that influence energy balance, both sides of the energy balance equation need to be considered. Alterations in nutrients may influence aspects of energy expenditure, not solely energy intake, and this may have implications for the efficacy of guidelines seeking to influence energy intake.

It is important to consider energy expenditure in the context of health. The most variable component of energy expenditure between individuals is physical activity energy expenditure (PAEE), which varies from ~600-2100 kcal per day in men of a similar demographic. Current guidelines do not regard the effect that changing dietary sugar might have on PAEE and therefore total energy expenditure.

Furthermore, there is increasing interest in restricting overall carbohydrate intake to treat metabolic disease or achieve ketogenesis. Very little is known about nutrition-physical activity interactions with this type of intervention.

This study will prescribe 3 diets to healthy males for 3 days in a randomised crossover design, where each participant will consume each of the diets. All food will be prepared and provided by the study team. The diets are as follows:

  1. Moderate sugar - reflecting the composition of a typical European diet
  2. Low sugar - similar macronutrient composition of a typical European diet but with <5% energy intake from free sugars (as per government guidelines)
  3. Low carbohydrate - low carbohydrate diet with <5% energy intake from sugar and <8% energy intake from carbohydrate, replacing carbohydrate energy with fat

Studietype

Intervensjonell

Registrering (Faktiske)

25

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Somerset
      • Bath, Somerset, Storbritannia, BA2 7AY
        • University of Bath

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • Body mass index 18.5-29.9 kg∙m-2
  • Age 18-65 years
  • Male
  • Able and willing to provide informed consent and safely comply with study procedures
  • No anticipated changes in physical activity during the study (e.g. holidays)

Exclusion Criteria:

  • Any reported condition or behaviour deemed either to pose undue personal risk to the participant or introduce bias
  • Any diagnosed metabolic disease (e.g. type 1 or type 2 diabetes)•Any reported use of substances which may pose undue personal risk to the participants or introduce bias into the experiment
  • Lifestyle not conforming to standard sleep-wake cycle (e.g. shift worker)
  • Any reported recent (<6 months) change in body mass (±3%)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: MODSUG
Diet consisting of 50% carbohydrate (20% sugar), 15% protein, 35% fat
Makronæringsstoffsammensetning (spesifikt type og/eller mengde karbohydrat) manipuleres
Eksperimentell: LOWSUG
Diet consisting of 50% carbohydrate (<5% sugar), 15% protein, 35% fat
Makronæringsstoffsammensetning (spesifikt type og/eller mengde karbohydrat) manipuleres
Eksperimentell: LOWCHO
Diet consisting of <8% carbohydrate (<5% sugar), 15% protein, >77% fat
Makronæringsstoffsammensetning (spesifikt type og/eller mengde karbohydrat) manipuleres

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physical activity energy expenditure (kj/day or kcal/day)
Tidsramme: 3 days
Physical activity energy expenditure measured using individually-calibrated combined heart rate and accelerometry (kj/day or kcal/day)
3 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time spent in different physical activity intensities (MET categories) (minutes)
Tidsramme: 3 days
Time spent in different physical activity intensities (MET categories) (minutes) using individually-calibrated combined heart rate and accelerometry
3 days
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day)
Tidsramme: 3 days
Energy expended in different physical activity intensities (MET categories) (kJ/day or kcal/day) using individually-calibrated combined heart rate and accelerometry
3 days
Energy expended in the postprandial period (kJ or kcal)
Tidsramme: 3 days
Energy expended in the postprandial period (kJ or kcal) measured using individually-calibrated combined heart rate and accelerometry
3 days
Fasting blood glucose concentrations
Tidsramme: 3 days
Measures of blood glucose concentrations pre- and post-intervention.
3 days
Fasting blood insulin concentrations
Tidsramme: 3 days
Measures of blood insulin concentrations pre- and post-intervention.
3 days
Fasting blood triglyceride concentrations
Tidsramme: 3 days
Measures of blood triglyceride concentrations pre- and post-intervention.
3 days
Fasting blood non-esterified fatty acid concentrations
Tidsramme: 3 days
Measures of blood non-esterified fatty acid concentrations pre- and post-intervention.
3 days
Fasting blood lactate concentrations
Tidsramme: 3 days
Measures of blood lactate concentrations pre- and post-intervention.
3 days
Fasting blood beta-hydroxybutyrate concentrations
Tidsramme: 3 days
Measures of blood beta-hydroxybutyrate concentrations pre- and post-intervention.
3 days
Fasting blood leptin concentrations
Tidsramme: 3 days
Measures of blood leptin concentrations pre- and post-intervention.
3 days
Fasting blood fibroblast growth factor-21 concentrations
Tidsramme: 3 days
Measures of blood fibroblast growth factor-21 concentrations pre- and post-intervention.
3 days
Fasting blood total cholesterol concentrations
Tidsramme: 3 days
Measures of blood total cholesterol concentrations pre- and post-intervention.
3 days
Fasting blood high density lipoprotein concentrations
Tidsramme: 3 days
Measures of blood high density lipoprotein concentrations pre- and post-intervention.
3 days
Fasting blood low density lipoprotein concentrations
Tidsramme: 3 days
Measures of blood low density lipoprotein concentrations pre- and post-intervention.
3 days
Food preference ratings
Tidsramme: 3 days
Food preference ratings determined by computer task measured pre- and post-intervention
3 days
Subjective appetite and mood ratings
Tidsramme: 3 days
Measured by 0-100 mm visual analogue scales measured pre- and post-intervention
3 days
Blood pressure
Tidsramme: 3 days
Blood pressure using an automated sphygmomanometer pre- and post-intervention
3 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2018

Primær fullføring (Faktiske)

1. juli 2021

Studiet fullført (Faktiske)

1. september 2021

Datoer for studieregistrering

Først innsendt

10. april 2019

Først innsendt som oppfylte QC-kriteriene

13. april 2019

Først lagt ut (Faktiske)

17. april 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. mai 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • EP 17/18 219

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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