CCRC: Effects of Partially Hydrolyzed Whey Peptides (PHWP) On Weight Loss In Individuals With The Metabolic Syndrome (METS)
Ключови думи
Резюме
Описание
The Metabolic Syndrome (METS) is a clinical disorder characterized by the following problems: Obesity, especially located in the waist area, elevated blood fats (lipids), high blood pressure and insulin resistance. The METS affects one third of the adult population in the USA and increases the risks for both diabetes and hardening of the arteries, leading to heart attacks and strokes.
The best treatment for improving the symptoms of METS is weight loss. In previous studies, it has been demonstrated that whey protein (WP) supplementation increased weight loss and especially fat-mass loss in obese, insulin resistant women when compared to carbohydrates. We now propose to compare WP to another protein source in patients with the METS during weight loss. In addition, we will use a special preparation called partially hydrolyzed whey protein, which may have specific properties that increase fat mass loss.
Дати
| Последна проверка: | 07/31/2008 |
| Първо изпратено: | 08/18/2008 |
| Очаквано записване подадено: | 08/18/2008 |
| Първо публикувано: | 08/20/2008 |
| Изпратена последна актуализация: | 10/24/2012 |
| Последна актуализация публикувана: | 10/28/2012 |
| Действителна начална дата на проучването: | 07/31/2008 |
| Приблизителна дата на първично завършване: | 07/31/2010 |
| Очаквана дата на завършване на проучването: | 07/31/2010 |
Състояние или заболяване
Интервенция / лечение
Dietary Supplement: Weight Loss
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: 1 Patients will be randomized to receive PHWP. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. | |
| Placebo Comparator: 2 Patients will be randomized to receive PHG. Since sex and baseline weight can influence the response, randomization will be stratified according to these variables. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - Clinical Diagnoses of Metabolic Syndrome (at least 3/5 of the following) - Waist Circumference: men: >40 in women: >35 in - Blood Pressure: >135/>85 mm Hg - Triglycerides: >150 mg/dl - HDL-cholesterol: men: <40 mg/dl women: <50 mg/dl - Fasting Glucose: >100 mg/dl - Ages 18 to 65 Years - BMI range of 27 to 42 kg/m^2 - Body weight <300 lbs - Weight Stable for 3 Months Exclusion Criteria: - Subjects who habitually consume protein supplements or have eating disorders - Recent delivery (within 12 months), lactation, pregnancy or intention to become pregnant - Type 2 diabetes, kidney disease, liver disease, anemia, gout, cancer, untreated thyroid disease, gastrointestinal disease, other metabolic diseases or malabsorption syndromes - Triglyceride >500 mg/dl, Cholesterol >260 mg/dl - Use of insulin sensitizers, lipid lowering medication or ACE inhibitors - Use of anti-obesity medications or supplements for at lease 6 months prior to start of study - Known allergy or adverse reaction to protein and dairy products (including lactose) |
Резултат
Първични изходни мерки
1. The investigators hope to determine the effects of incorporating PHWP into the diet of a person diagnosed with METS. [2 Years]
