PrOtein and WEight Loss in teenageRs
Mots clés
Abstrait
La description
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).
Rendez-vous
| Dernière vérification: | 12/31/2015 |
| Première soumission: | 03/02/2014 |
| Inscription estimée soumise: | 03/04/2014 |
| Première publication: | 03/05/2014 |
| Dernière mise à jour soumise: | 01/06/2016 |
| Dernière mise à jour publiée: | 01/10/2016 |
| Date de début réelle de l'étude: | 02/28/2014 |
| Date d'achèvement primaire estimée: | 06/30/2015 |
| Date estimée d'achèvement de l'étude: | 06/30/2015 |
Condition ou maladie
Intervention / traitement
Behavioral: Energy Restriction
Behavioral: Higher protein and energy restriction
Behavioral: Lower protein and energy restriction
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: Higher protein and energy restriction Participants in this arm will consume 30% of energy as protein with 25% energy restriction. | Behavioral: Higher protein and energy restriction 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. |
| Experimental: Lower protein and energy restriction Participants in this arm will consume 15% of energy as protein with 25% energy restriction. | Behavioral: Lower protein and energy restriction 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. |
Critère d'éligibilité
| Âges éligibles aux études | 12 Years À 12 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | 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. |
Résultat
Mesures des résultats primaires
1. BMI Z-Score [up to Week 12]
Mesures des résultats secondaires
1. Subjective Ratings of Appetite [Baseline and Week 12]
2. Hexosamine Biosynthetic Pathway [Baseline and Week 12]
Autres mesures des résultats
1. Glucose [Baseline and Week 12]
2. Insulin [Baseline and Week 12]
3. Cholesterol [Baseline and Week 12]
4. Triglycerides [Baseline and Week 12]
5. Blood Pressure [Baseline and Week 12]
