Calcium Supplementation for a Healthy Weight-Lite (CaSHeW Lite)

NCT00386672 | Completed

• 1 other identifier: 2006-P-000505
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Overweight

Keywords

Calcium; Vitamin D; Weight Loss; Overweight; Obesity; Lite Orange Juice

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Baseline and at 16 weeks

Secondary Outcomes (2)

• Change in visceral adipose tissue mass

  Baseline and at 16 weeks

• Change in subcutaneous adipose tissue mass

  Baseline and at 16 weeks

Study Arms (2)

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.

Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D; Behavioral: Nutrition Counseling

Lite OJ without Ca and VitD

ACTIVE COMPARATOR

240ml of reduced energy (lite) OJ beverage, 3 times per day.

Behavioral: Nutrition Counseling; Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D

Interventions

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.

Also known as: Minute Maid Light Orange Juice

Lite OJ with Ca and VitD

Nutrition Counseling BEHAVIORAL

Individual and group nutritional counseling by a registered dietician.

Lite OJ with Ca and VitD; Lite OJ without Ca and VitD

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.

Also known as: Minute Maid Light Orange Juice

Lite OJ without Ca and VitD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women, between 18 and 65 years of age, who are capable of providing informed consent.
• BMI of 25 to 35 kg/m2.
• Non-smoker (for at least 6 months).
• In good health, as determined by the principal investigator based on medical history and physical examination.
• Clinical laboratory evaluations (including Biochemistry, Hematology, Endocrinology) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
• Because of the calorie-restricted diet and radiation exposure from the CT scan, females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile for at least 3 months, or be willing to use an approved method of contraception (which may include use of abstinence; intrauterine device; female condom with spermicide; diaphragm with spermicide; cervical cap with spermicide; oral or transdermal hormonal contraceptives; a condom with spermicide by the sexual partner; or a sterile sexual partner) from 35 days prior to study entry (i.e., Day -1) until 30 days following Study Completion. For all females, the pregnancy test result must be negative at the screening visit and at visits when a CT scan will be done.
• Ability to comprehend and willingness to sign the Informed Consent Form for this study.
• Ability to comply with study restrictions regarding diet and exercise.
• Stable weight (+ 5%) for at least 3 months prior to study entry.

You may not qualify if:

• Diabetes mellitus.
• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
• Participation in any other investigational diet study within 90 days prior to study entry.
• History of a medical or psychological condition or social circumstances that would impair the subject's ability to participate reliably in the study.
• Use within the last six months of medications that can result in significant weight gain or weight loss, including antipsychotics, selective serotonin reuptake inhibitors, anti-epileptic drugs, appetite-suppressants such as phentermine and sibutramine, and the lipase-inhibitor orlistat. (see Appendix 1 for detailed list)
• Active eating disorder.
• History of alcoholism or substance abuse within 5 years prior to study entry.
• Recommendation by a physician to avoid calcium supplements because of a history of kidney stones or other medical condition.
• History of hyperparathyroidism or sarcoidosis.
• Osteoporosis or other medical condition for which a physician has recommended taking a multivitamin or calcium supplementation.
• High calcium intake (more than 2 servings of dairy products per day or taking calcium supplements \> 3x/wk ) for 1 month prior to study start date and for duration of study. (If participant is taking calcium supplement \> 3x/wk or more than 2 servings of dairy products per day, they are eligible to participate if they agree to stop for 1 month prior to study start date and for the duration of the study. Participants will similarly be asked to stop multivitamins as the majority of these supplements contain calcium.)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• The Beverage Institute for Health and Wellness: collaborator

Study Sites (1)

Massachusetts General Hospital Weight Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (20)

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  PMID: 10546691 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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• 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.

  PMID: 11134120 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.

  PMID: 12791622 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.

  PMID: 11999543 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.

  PMID: 10834935 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.

  PMID: 11606486 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.

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• 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.

  PMID: 11156940 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.

  PMID: 11454514 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.

  PMID: 7584878 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.

  PMID: 2991340 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.

  PMID: 3145124 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.

  PMID: 12223452 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.

  PMID: 15231722 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.

  PMID: 15141427 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.

  PMID: 12586999 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.

  PMID: 11966382 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.

  PMID: 11999544 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.

  PMID: 22170363 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Calcium; Vitamin D

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Lee M Kaplan, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MGH Weight Center

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (1)