Effect of Soy Protein and Colorado Diet on Weight Loss and Maintenance
2018年11月6日 更新者：University of Colorado, Denver
The Effect of Incorporating Soy Protein Foods in the Colorado Diet for Weight Loss and Maintenance.
Dietary protein is a key element of most effective weight loss regimens.
This study will investigate the effects of consuming soy protein on body composition and cardiometabolic health within the context of an effective weight loss and maintenance program called the Colorado Diet.
調査の概要
詳細な説明
This is a randomized study involving 60 study subjects (30 per arm). Investigators plan to enroll 72 subjects (36 per arm) in order to allow for any potential drop outs with the goal of 60 study completers. Investigators will compare the efficacy of inducing weight loss of two treatment arms all based on the Colorado Diet. Subjects will be randomly assigned to one of two study arms and instructed to follow the Colorado Diet by participating in weekly Colorado Diet group classes (State of Slim class). There will be 4 classes of 18 subjects each (two classes for each treatment group). Subjects will be followed in the study for 12 months. Subjects will be randomized into one of two treatment groups as follows:
- Group 1 will participate in a State of Slim group class, receive a State of Slim book (describing the Colorado Diet), and will then purchase food items allowed in the Colorado Diet from the lists of acceptable foods in the State of Slim book.
- Group 2 will participate in a State of Slim class, receive the State of Slim book, and be provided soy protein foods to be consumed as part of the Colorado Diet (subjects will receive up to 3 foods with approximately 20g of soy protein each, per day).
研究の種類
介入
入学 (実際)
71
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Denver, Anschutz Health and Wellness Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～55年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Males and females ages 18 - 55 years
- BMI between 27-40
- Weight stable (have not lost or gained more than 10 pounds in the last 3 months)
- Generally healthy
- Able to exercise 70 minutes per day at moderate intensity
- Willing and able to participate in a State of Slim group class for the first 16 weeks of the study and willing to participate in 5 study visits over the 12 month study period.
Exclusion Criteria:
- Pregnant or trying to become pregnant.
- Diagnosis of type 1 or type 2 diabetes
- Individuals following a vegetarian only diet
- Food allergies (to soy, dairy, wheat/gluten, eggs, or peanuts)
- Taking medications that could cause weight loss or weight gain or alter plasma lipids (such as steroids, tricyclic antidepressants, chemotherapy, antipsychotics, prescribed or over-the-counter weight loss agents, statins, fibrates, niacin, etc). Oral contraceptives can be used as long as subject agrees to not change use of these during the study. Multivitamins containing niacin can be used as long as subject agrees to not change use of these during the study.
- Known renal disease
- hypothyroidism
- Current alcohol or drug abuse or dependence (Subjects who have quit smoking in the last 6 months will be excluded. Smokers whose smoking habits have been stable for the last 6 months and which remain stable during the study can be included).
- Any medical condition for which following a diet and/or 70 minutes of exercise daily would be inadvisable
- LDL cholesterol levels above 190 mg/dl or triglycerides above 400 mg/dl.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 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 |
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実験的：Soy Group
Subjects in the soy group were asked to participate in the Colorado Diet program and to consume 3 soy food items per day.
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他の：Non-soy Group
Subjects in the non-soy group were asked to participate in the Colorado Diet program and to avoid soy food products.
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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 |
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Change from baseline in % body weight at the end of a 16 week period
時間枠：at month 4
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at month 4
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Change from baseline in body fat at the end of 16 week period
時間枠：at month 4
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at month 4
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Change from baseline in % body weight at the end of a 52 week period
時間枠：at month 12
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at month 12
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Change from baseline in body fat at the end of a 52 week period
時間枠：at month 12
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at month 12
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Change from baseline in lipid panel results at end of 16 week period (total cholesterol)
時間枠：at month 4
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at month 4
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Change from baseline in lipid panel results at end of 52 week period (total cholesterol)
時間枠：at month 12
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at month 12
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Change from baseline in lipid panel results at end of 16 week period (LDL)
時間枠：at month 4
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at month 4
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Change from baseline in lipid panel results at end of 52 week period (LDLl)
時間枠：at month 12
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at month 12
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Change from baseline in lipid panel results at end of 16 week period (HDL)
時間枠：at month 4
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at month 4
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Change from baseline in lipid panel results at end of 52 week period (HDL)
時間枠：at month 12
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at month 12
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Change from baseline in lipid panel results at end of 16 week period (triglycerides)
時間枠：at month 4
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at month 4
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Change from baseline in lipid panel results at end of 52 week period (triglycerides)
時間枠：at month 12
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at month 12
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：James O Hill, PhD、University of Colorado, Denver
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Anderson GH, Moore SE. Dietary proteins in the regulation of food intake and body weight in humans. J Nutr. 2004 Apr;134(4):974S-9S. doi: 10.1093/jn/134.4.974S.
- Anderson GH, Tecimer SN, Shah D, Zafar TA. Protein source, quantity, and time of consumption determine the effect of proteins on short-term food intake in young men. J Nutr. 2004 Nov;134(11):3011-5. doi: 10.1093/jn/134.11.3011.
- Anderson JW, Johnstone BM, Cook-Newell ME. Meta-analysis of the effects of soy protein intake on serum lipids. N Engl J Med. 1995 Aug 3;333(5):276-82. doi: 10.1056/NEJM199508033330502.
- Anthony TG, McDaniel BJ, Knoll P, Bunpo P, Paul GL, McNurlan MA. Feeding meals containing soy or whey protein after exercise stimulates protein synthesis and translation initiation in the skeletal muscle of male rats. J Nutr. 2007 Feb;137(2):357-62. doi: 10.1093/jn/137.2.357.
- Arciero PJ, Baur D, Connelly S, Ormsbee MJ. Timed-daily ingestion of whey protein and exercise training reduces visceral adipose tissue mass and improves insulin resistance: the PRISE study. J Appl Physiol (1985). 2014 Jul 1;117(1):1-10. doi: 10.1152/japplphysiol.00152.2014. Epub 2014 May 15.
- Baer DJ, Stote KS, Paul DR, Harris GK, Rumpler WV, Clevidence BA. Whey protein but not soy protein supplementation alters body weight and composition in free-living overweight and obese adults. J Nutr. 2011 Aug;141(8):1489-94. doi: 10.3945/jn.111.139840. Epub 2011 Jun 15.
- Barkeling B, Rossner S, Bjorvell H. Effects of a high-protein meal (meat) and a high-carbohydrate meal (vegetarian) on satiety measured by automated computerized monitoring of subsequent food intake, motivation to eat and food preferences. Int J Obes. 1990 Sep;14(9):743-51.
- Booth DA, Chase A, Campbell AT. Relative effectiveness of protein in the late stages of appetite suppression in man. Physiol Behav. 1970 Nov;5(11):1299-302. doi: 10.1016/0031-9384(70)90044-2. No abstract available.
- Bowen J, Noakes M, Clifton PM. Appetite regulatory hormone responses to various dietary proteins differ by body mass index status despite similar reductions in ad libitum energy intake. J Clin Endocrinol Metab. 2006 Aug;91(8):2913-9. doi: 10.1210/jc.2006-0609. Epub 2006 May 30.
- Brown EC, DiSilvestro RA, Babaknia A, Devor ST. Soy versus whey protein bars: effects on exercise training impact on lean body mass and antioxidant status. Nutr J. 2004 Dec 8;3:22. doi: 10.1186/1475-2891-3-22.
- Elia D, Stadler K, Horvath V, Jakus J. Effect of soy- and whey protein-isolate supplemented diet on the redox parameters of trained mice. Eur J Nutr. 2006 Aug;45(5):259-66. doi: 10.1007/s00394-006-0593-z. Epub 2006 Mar 30.
- Kalman D, Feldman S, Martinez M, Krieger DR, Tallon MJ. Effect of protein source and resistance training on body composition and sex hormones. J Int Soc Sports Nutr. 2007 Jul 23;4:4. doi: 10.1186/1550-2783-4-4.
- Latner JD, Schwartz M. The effects of a high-carbohydrate, high-protein or balanced lunch upon later food intake and hunger ratings. Appetite. 1999 Aug;33(1):119-28. doi: 10.1006/appe.1999.0237.
- Marmonier C, Chapelot D, Louis-Sylvestre J. Effects of macronutrient content and energy density of snacks consumed in a satiety state on the onset of the next meal. Appetite. 2000 Apr;34(2):161-8. doi: 10.1006/appe.1999.0302.
- Paddon-Jones D, Westman E, Mattes RD, Wolfe RR, Astrup A, Westerterp-Plantenga M. Protein, weight management, and satiety. Am J Clin Nutr. 2008 May;87(5):1558S-1561S. doi: 10.1093/ajcn/87.5.1558S.
- Porrini M, Santangelo A, Crovetti R, Riso P, Testolin G, Blundell JE. Weight, protein, fat, and timing of preloads affect food intake. Physiol Behav. 1997 Sep;62(3):563-70. doi: 10.1016/s0031-9384(97)00162-5.
- Rolls BJ, Hetherington M, Burley VJ. The specificity of satiety: the influence of foods of different macronutrient content on the development of satiety. Physiol Behav. 1988;43(2):145-53. doi: 10.1016/0031-9384(88)90230-2.
- Sites CK, Cooper BC, Toth MJ, Gastaldelli A, Arabshahi A, Barnes S. Effect of a daily supplement of soy protein on body composition and insulin secretion in postmenopausal women. Fertil Steril. 2007 Dec;88(6):1609-17. doi: 10.1016/j.fertnstert.2007.01.061. Epub 2007 Apr 6.
- Veldhorst MA, Nieuwenhuizen AG, Hochstenbach-Waelen A, van Vught AJ, Westerterp KR, Engelen MP, Brummer RJ, Deutz NE, Westerterp-Plantenga MS. Dose-dependent satiating effect of whey relative to casein or soy. Physiol Behav. 2009 Mar 23;96(4-5):675-82. doi: 10.1016/j.physbeh.2009.01.004.
- Westerterp-Plantenga MS, Nieuwenhuizen A, Tome D, Soenen S, Westerterp KR. Dietary protein, weight loss, and weight maintenance. Annu Rev Nutr. 2009;29:21-41. doi: 10.1146/annurev-nutr-080508-141056.
- Hill, JH, Blundell, JE. Macronutrients and satiety: The effects of a high-protein or high-carbohydrate meal on subjective motivation to eat and food preferences. Nutr. Behav. 3: 133-144, 1986.
- Peters, JC. Control of Energy Balance. Biochemical, physiological, molecular aspects of human nutrition 2nd edition, M.H. Stipanuk ed. Saunders Elsevier: 618-639, 2006.
- Speaker KJ, Sayer RD, Peters JC, Foley HN, Pan Z, Wyatt HR, Flock MR, Mukherjea R, Hill JO. Effects of consuming a high-protein diet with or without soy protein during weight loss and maintenance: a non-inferiority, randomized clinical efficacy trial. Obes Sci Pract. 2018 May 21;4(4):357-366. doi: 10.1002/osp4.278. eCollection 2018 Aug.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2015年3月10日
一次修了 (実際)
2016年10月29日
研究の完了 (実際)
2016年10月29日
試験登録日
最初に提出
2017年8月9日
QC基準を満たした最初の提出物
2017年8月11日
最初の投稿 (実際)
2017年8月14日
学習記録の更新
投稿された最後の更新 (実際)
2018年11月7日
QC基準を満たした最後の更新が送信されました
2018年11月6日
最終確認日
2018年11月1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。
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