Calcium Supplementation for a Healthy Weight (CaSHeW)

This study has been completed.
Sponsor:
Collaborator:
The Beverage Institute for Health and Wellness, LLC
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01363115
First received: May 26, 2011
Last updated: May 27, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Obesity
Overweight
Dietary Supplement: Orange Juice fortified with Calcium and Vitamin D
Dietary Supplement: Orange juice without Ca or VitD
Behavioral: Nutritional Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calcium Supplementation for a Healthy Weight (CaSHeW)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in body weight [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in visceral adipose tissue mass [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Change in subcutaneous adipose tissue mass [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: July 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OJ fortified with Ca and VitD
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
Three 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving
Other Name: Minute Maid regular calorie orange juice
Behavioral: Nutritional Counseling
Individual and group nutritional counseling by a registered dietitian
Active Comparator: OJ without VitD and Ca
Regular OJ without Calcium or Vitamin D3: one 8 fluid oz serving three times/day (control)
Dietary Supplement: Orange juice without Ca or VitD
Three 240 mL glasses of orange juice without Ca or VitD
Other Name: Minute Maid regular calorie orange juice
Behavioral: Nutritional Counseling
Individual and group nutritional counseling by a registered dietitian

Detailed Description:

The prevalence of obesity and levels of overweight is rising worldwide. In the United States, 63% of men and 55% of women are now overweight or obese. Recent epidemiological data and clinical trials have shown that a small daily increase in calcium or dairy products may result in annual losses in body weight and body fat. Data from clinical studies suggest that a 1000 mg per day increase in calcium intake is associated with an 8 kg difference in mean body weight and that calcium intake explains about 3% of the variance in body weight.

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.

Otherwise healthy overweight and obese men and women ages 18 to 65 years with a BMI between 25 and 35 kg/m2 will be randomized into one of the following experimental groups (36 in each group):

  1. Regular OJ: one 8 fluid oz serving three times/day (control)
  2. 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)

Subjects will receive either orange juice (OJ) (control) or OJ fortified with calcium and vitamin D3 (treatment) for 16 weeks. The study will involve 6 outpatient study visits to the study center.

Primary endpoint: Change in body weight after 16 weeks Secondary endpoint: Visceral fat change after 16 weeks as measured by single slice CT scan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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, 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.

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.
  • 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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363115

Locations
United States, Massachusetts
Massachusetts General Hospital Weight Center
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
The Beverage Institute for Health and Wellness, LLC
Investigators
Principal Investigator: Lee M Kaplan, MD, PhD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee M. Kaplan, MD, PhD, Massachusetts Genral Hosptial
ClinicalTrials.gov Identifier: NCT01363115     History of Changes
Other Study ID Numbers: 2005-P-000414
Study First Received: May 26, 2011
Last Updated: May 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Body Weight
Dietary Supplement
Calcium
Vitamin D

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Calcium, Dietary
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 26, 2014