Calcium Supplementation for a Healthy Weight (CaSHeW)

NCT01363115 | Completed

• 1 other identifier: 2005-P-000414
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to investigate the effect of calcium (Ca) and vitamin D (D) supplemented orange juice (OJ) on weight loss and visceral fat mass in overweight and obese adults.

Conditions

Obesity; Overweight

Keywords

Body Weight; Dietary Supplement; Calcium; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Baseline and 16 weeks

Secondary Outcomes (2)

• Change in visceral adipose tissue mass

  Baseline and 16 weeks

• Change in subcutaneous adipose tissue mass

  Baseline and 16 weeks

Study Arms (2)

OJ fortified with Ca and VitD

EXPERIMENTAL

Regular OJ fortified with Calcium (350 mg/8 fluid oz serving) and Vitamin D3 (100 IU/8 fluid oz serving): one 8 fluid oz serving three times/day (treatment) in combination with nutritional counseling

Dietary Supplement: Orange Juice fortified with Calcium and Vitamin D; Behavioral: Nutritional Counseling

OJ without VitD and Ca

ACTIVE COMPARATOR

Regular OJ without Calcium or Vitamin D3: one 8 fluid oz serving three times/day (control)

Dietary Supplement: Orange juice without Ca or VitD; Behavioral: Nutritional Counseling

Interventions

Orange Juice fortified with Calcium and Vitamin D DIETARY_SUPPLEMENT

Three 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving

Also known as: Minute Maid regular calorie orange juice

OJ fortified with Ca and VitD

Orange juice without Ca or VitD DIETARY_SUPPLEMENT

Three 240 mL glasses of orange juice without Ca or VitD

Also known as: Minute Maid regular calorie orange juice

OJ without VitD and Ca

Nutritional Counseling BEHAVIORAL

Individual and group nutritional counseling by a registered dietitian

OJ fortified with Ca and VitD; OJ without VitD and Ca

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, Urinalysis) 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; non-hormonal intrauterine device with spermicide; 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.
• Active eating disorder
• History of alcoholism or substance abuse within 5 years prior to study entry.
• Use of a dietary supplement or medication that decreases calcium absorption
• History of kidney stone, hyperparathyroidism or sarcoidosis
• 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 & Wellness: collaborator

Study Sites (1)

Massachusetts General Hospital Weight Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Body Weight

Interventions

Calcium; Vitamin D; Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

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

Study Record Dates

• First Submitted: May 26, 2011
• First Posted: June 1, 2011
• Study Start: July 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 1, 2011

Record last verified: 2011-05

Locations

US (1)