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| Name | Class |
|---|---|
| The Beverage Institute for Health and Wellness | UNKNOWN |
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The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight.
Recent studies suggest that calcium may be important for weight loss, but other studies have not had the same results. The purpose of the study is to find out if taking calcium and vitamin D supplements, while following a low-calorie diet, can help people lose weight.
We will use special orange juice with less calories than regular orange juice. Half of the subjects in this study will drink the study juice (reduced-calorie orange juice) containing extra calcium and vitamin D. The other subjects will drink reduced-calorie orange juice without any extra calcium or vitamin D in it.
Comparisons: We will compare subjects who follow the diet and take calcium and vitamin D supplements to those who only follow the diet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lite OJ with Ca and VitD | Experimental | 240ml of reduced energy (lite) OJ beverage fortified with 350mg Ca and 100U VitD, 3 times per day. |
|
| Lite OJ without Ca and VitD | Active Comparator | 240ml of reduced energy (lite) OJ beverage, 3 times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced energy (lite) OJ fortified with Calcium and Vitamin D | Dietary Supplement | Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Baseline and at 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in visceral adipose tissue mass | Baseline and at 16 weeks | |
| Change in subcutaneous adipose tissue mass | Baseline and at 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lee M Kaplan, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Weight Center | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10546691 | Background | Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523. | |
| 9545015 | Background | Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Obes Res. 1998 Mar;6(2):97-106. doi: 10.1002/j.1550-8528.1998.tb00322.x. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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|
| Nutrition Counseling | Behavioral | Individual and group nutritional counseling by a registered dietician. |
|
| Reduced energy (lite) OJ without Calcium and Vitamin D | Dietary Supplement | Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day. |
|
|
| 11134120 | Background | Davies KM, Heaney RP, Recker RR, Lappe JM, Barger-Lux MJ, Rafferty K, Hinders S. Calcium intake and body weight. J Clin Endocrinol Metab. 2000 Dec;85(12):4635-8. doi: 10.1210/jcem.85.12.7063. |
| 12791622 | Background | Jacqmain M, Doucet E, Despres JP, Bouchard C, Tremblay A. Calcium intake, body composition, and lipoprotein-lipid concentrations in adults. Am J Clin Nutr. 2003 Jun;77(6):1448-52. doi: 10.1093/ajcn/77.6.1448. |
| 11999543 | Background | Zemel MB. Regulation of adiposity and obesity risk by dietary calcium: mechanisms and implications. J Am Coll Nutr. 2002 Apr;21(2):146S-151S. doi: 10.1080/07315724.2002.10719212. |
| 10834935 | Background | Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of adiposity by dietary calcium. FASEB J. 2000 Jun;14(9):1132-8. |
| 11606486 | Background | Shi H, Norman AW, Okamura WH, Sen A, Zemel MB. 1alpha,25-Dihydroxyvitamin D3 modulates human adipocyte metabolism via nongenomic action. FASEB J. 2001 Dec;15(14):2751-3. doi: 10.1096/fj.01-0584fje. Epub 2001 Oct 15. |
| 12733746 | Background | Zemel MB. Role of dietary calcium and dairy products in modulating adiposity. Lipids. 2003 Feb;38(2):139-46. doi: 10.1007/s11745-003-1044-6. |
| 11156940 | Background | Shi H, Dirienzo D, Zemel MB. Effects of dietary calcium on adipocyte lipid metabolism and body weight regulation in energy-restricted aP2-agouti transgenic mice. FASEB J. 2001 Feb;15(2):291-3. doi: 10.1096/fj.00-0584fje. Epub 2000 Dec 8. |
| 11454514 | Background | Ye WZ, Reis AF, Dubois-Laforgue D, Bellanne-Chantelot C, Timsit J, Velho G. Vitamin D receptor gene polymorphisms are associated with obesity in type 2 diabetic subjects with early age of onset. Eur J Endocrinol. 2001 Aug;145(2):181-6. doi: 10.1530/eje.0.1450181. |
| 7584878 | Background | Barger-Lux MJ, Heaney RP, Hayes J, DeLuca HF, Johnson ML, Gong G. Vitamin D receptor gene polymorphism, bone mass, body size, and vitamin D receptor density. Calcif Tissue Int. 1995 Aug;57(2):161-2. doi: 10.1007/BF00298438. |
| 2991340 | Background | Bell NH, Epstein S, Greene A, Shary J, Oexmann MJ, Shaw S. Evidence for alteration of the vitamin D-endocrine system in obese subjects. J Clin Invest. 1985 Jul;76(1):370-3. doi: 10.1172/JCI111971. |
| 3145124 | Background | Liel Y, Ulmer E, Shary J, Hollis BW, Bell NH. Low circulating vitamin D in obesity. Calcif Tissue Int. 1988 Oct;43(4):199-201. doi: 10.1007/BF02555135. |
| 12223452 | Background | Shi H, Norman AW, Okamura WH, Sen A, Zemel MB. 1alpha,25-dihydroxyvitamin D3 inhibits uncoupling protein 2 expression in human adipocytes. FASEB J. 2002 Nov;16(13):1808-10. doi: 10.1096/fj.02-0255fje. Epub 2002 Sep 5. |
| 15231722 | Background | Sun X, Zemel MB. Role of uncoupling protein 2 (UCP2) expression and 1alpha, 25-dihydroxyvitamin D3 in modulating adipocyte apoptosis. FASEB J. 2004 Sep;18(12):1430-2. doi: 10.1096/fj.04-1971fje. Epub 2004 Jul 1. |
| 15141427 | Background | Zemel MB, Miller SL. Dietary calcium and dairy modulation of adiposity and obesity risk. Nutr Rev. 2004 Apr;62(4):125-31. doi: 10.1111/j.1753-4887.2004.tb00034.x. |
| 12586999 | Background | Melanson EL, Sharp TA, Schneider J, Donahoo WT, Grunwald GK, Hill JO. Relation between calcium intake and fat oxidation in adult humans. Int J Obes Relat Metab Disord. 2003 Feb;27(2):196-203. doi: 10.1038/sj.ijo.802202. |
| 11966382 | Background | Pereira MA, Jacobs DR Jr, Van Horn L, Slattery ML, Kartashov AI, Ludwig DS. Dairy consumption, obesity, and the insulin resistance syndrome in young adults: the CARDIA Study. JAMA. 2002 Apr 24;287(16):2081-9. doi: 10.1001/jama.287.16.2081. |
| 11999544 | Background | Heaney RP, Davies KM, Barger-Lux MJ. Calcium and weight: clinical studies. J Am Coll Nutr. 2002 Apr;21(2):152S-155S. doi: 10.1080/07315724.2002.10719213. |
| 22170363 | Background | Rosenblum JL, Castro VM, Moore CE, Kaplan LM. Calcium and vitamin D supplementation is associated with decreased abdominal visceral adipose tissue in overweight and obese adults. Am J Clin Nutr. 2012 Jan;95(1):101-8. doi: 10.3945/ajcn.111.019489. Epub 2011 Dec 14. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |