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

Obesity Clinical Trial

Official title:

Calcium Supplementation for a Healthy Weight- LITE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386672
• Other study ID #: 2006-P-000505
• Status: Completed
• Phase: N/A
• First received: October 6, 2006
• Last updated: January 9, 2017
• Start date: May 2006
• Est. completion date: December 2006

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

• General medical conditions that are well-controlled will not be a basis for exclusion in the study. Subjects with uncontrolled conditions that are not adequately controlled or that might pose an unacceptable risk for participation, as clinically determined by the investigators, will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Dietary Supplement:
• Reduced energy (lite) OJ fortified with Calcium and Vitamin D
Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.

Behavioral:
• Nutrition Counseling
Individual and group nutritional counseling by a registered dietician.

Dietary Supplement:
• Reduced energy (lite) OJ without Calcium and Vitamin D
Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Weight Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	The Beverage Institute for Health and Wellness

Country where clinical trial is conducted

United States, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

Heaney RP, Davies KM, Barger-Lux MJ. Calcium and weight: clinical studies. J Am Coll Nutr. 2002 Apr;21(2):152S-155S. Review. — View Citation

Jacqmain M, Doucet E, Després 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Obes Res. 1998 Mar;6(2):97-106. Review. — View Citation

Ye WZ, Reis AF, Dubois-Laforgue D, Bellanné-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. — View Citation

Zemel MB, Miller SL. Dietary calcium and dairy modulation of adiposity and obesity risk. Nutr Rev. 2004 Apr;62(4):125-31. Review. — View Citation

Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of adiposity by dietary calcium. FASEB J. 2000 Jun;14(9):1132-8. — View Citation

Zemel MB. Regulation of adiposity and obesity risk by dietary calcium: mechanisms and implications. J Am Coll Nutr. 2002 Apr;21(2):146S-151S. Review. — View Citation

Zemel MB. Role of dietary calcium and dairy products in modulating adiposity. Lipids. 2003 Feb;38(2):139-46. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline and at 16 weeks	No
Secondary	Change in visceral adipose tissue mass		Baseline and at 16 weeks	No
Secondary	Change in subcutaneous adipose tissue mass		Baseline and at 16 weeks	No