10 代のタンパク質と体重の減少 (POWER)
肥満青年の体重減少に対するさまざまな主要栄養素組成の影響
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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
- Pennington Biomedical Research Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
BMI Zスコア
時間枠：12週目まで
|
12週目まで
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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食欲の主観的評価
時間枠：ベースラインと12週目
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ベースラインと12週目
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Hexosamine Biosynthetic Pathway
時間枠：Baseline and Week 12
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glutamine fructose-6-phosphate amidotransferase (GFAT) and glycosylation measured as O-linked N-acetylglucosamine (GlcNAc) transferase (OGT) measurement |
Baseline and Week 12
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
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グルコース
時間枠：ベースラインと12週目
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ベースラインと12週目
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インスリン
時間枠：ベースラインと12週目
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ベースラインと12週目
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コレステロール
時間枠：ベースラインと12週目
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ベースラインと12週目
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トリグリセリド
時間枠：ベースラインと12週目
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ベースラインと12週目
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血圧
時間枠：ベースラインと12週目
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ベースラインと12週目
|
協力者と研究者
捜査官
- 主任研究者：John W Apolzan, PhD、Pennington Biomedical
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。