Protein og vekttap hos tenåringer (POWER)
Effekter av variert makronæringsstoffsammensetning på vekttap hos overvektige ungdommer
The aim of the proposed study is to provide important data on weight loss efficacy in overweight and obese adolescents on an isocaloric higher protein diet vs a lower protein diet utilizing the U.S. Department of Agriculture (USDA) MyPlate nutrition guide. The investigators hypothesize that the higher protein diet will result in greater weight loss due to increased satiety and better dietary adherence.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Aim 1 is to test the efficacy of a personalized higher protein weight loss intervention compared to a lower protein intervention which use the USDA MyPlate nutrition guide.
It is hypothesized that participants randomly assigned to the higher protein dietary treatment will lose more weight based on BMI-Z score over 12 weeks compared to participants in the lower dietary protein treatment.
Aim 2 is to test if changes in subjective ratings of appetite differ by dietary treatment (i.e. protein intake).
It is hypothesized that participants in the higher protein intervention will report a decrease in hunger and an increase in fullness compared to participants in the lower protein intervention.
Aim 3 is to test if change in the hexosamine biosynthetic pathway (HBP) measured at the rate limiting step of glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) differ by dietary treatment.
It is hypothesized that participants randomly assigned to the higher protein dietary treatment will have decreased change from baseline levels of GFAT and glycosylation (OGT) due to decreased carbohydrate intake compared to the lower protein treatment.
Exploratory Aims: As exploratory aims, the investigators will test if the higher protein or lower protein dietary treatments differentially alter glucose, insulin, cholesterol, and triglycerides (markers of the metabolic syndrome).
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Louisiana
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Baton Rouge, Louisiana, Forente stater, 70808
- Pennington Biomedical Research Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Be male or female
- Be between the ages of 12 and 17, inclusive
- Be at or above the 85th BMI percentile (a number calculated from the participants height, weight, sex, and date of birth)
- Be willing to fast for 12 hours prior to clinic study visits 2 and 4
- Be willing to participate in the research study
Exclusion Criteria:
- Health Conditions:
- Has HIV or AIDS
- Has uncontrolled CVD or arrhythmia
- Has Type I or Type II diabetes.
- Is unable or unwilling to complete the study procedures
- Participant may not qualify for this study based on other exclusion criteria not listed. The study coordinator will go over this information in detail.
Medications:
- Diuretics
- Beta-blocker
- Weight loss medications, diet pills
- Anti-inflammatory drugs (corticosteroid/anabolic steroid/NSAID)
- Antipsychotic medications
- Other medications that may affect fluid balance or weight
Lifestyle:
• Plans to move out of the study area within the next 4 months, or plan to be out of the study area for more than 3 weeks during the course of the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Higher protein and energy restriction
Participants in this arm will consume 30% of energy as protein with 25% energy restriction. |
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity. Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity. The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively. |
|
Eksperimentell: Lower protein and energy restriction
Participants in this arm will consume 15% of energy as protein with 25% energy restriction. |
Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity. Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity. The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
BMI Z-score
Tidsramme: til uke 12
|
til uke 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjektiv vurdering av appetitt
Tidsramme: Grunnlinje og uke 12
|
Grunnlinje og uke 12
|
|
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Hexosamine Biosynthetic Pathway
Tidsramme: Baseline and Week 12
|
glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement |
Baseline and Week 12
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Glukose
Tidsramme: Grunnlinje og uke 12
|
Grunnlinje og uke 12
|
|
Insulin
Tidsramme: Grunnlinje og uke 12
|
Grunnlinje og uke 12
|
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Kolesterol
Tidsramme: Grunnlinje og uke 12
|
Grunnlinje og uke 12
|
|
Triglyserider
Tidsramme: Grunnlinje og uke 12
|
Grunnlinje og uke 12
|
|
Blodtrykk
Tidsramme: Grunnlinje og uke 12
|
Grunnlinje og uke 12
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: John W Apolzan, PhD, Pennington Biomedical
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Antatt)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBRC 2014-014
Legemiddel- og utstyrsinformasjon, studiedokumenter
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