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

This study has been completed.
Sponsor:
Collaborator:
The Beverage Institute for Health and Wellness
Information provided by (Responsible Party):
Lee Kaplan MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00386672
First received: October 6, 2006
Last updated: January 9, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Obesity Overweight Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D Behavioral: Nutrition Counseling Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Calcium Supplementation for a Healthy Weight- LITE

Resource links provided by NLM:


Further study details as provided by Lee Kaplan MD, PhD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in body weight [ Time Frame: Baseline and at 16 weeks ]

Secondary Outcome Measures:
  • Change in visceral adipose tissue mass [ Time Frame: Baseline and at 16 weeks ]
  • Change in subcutaneous adipose tissue mass [ Time Frame: Baseline and at 16 weeks ]

Enrollment: 83
Study Start Date: May 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lite OJ with Ca and VitD
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
Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.
Other Name: Minute Maid Light Orange Juice
Behavioral: Nutrition Counseling
Individual and group nutritional counseling by a registered dietician.
Active Comparator: Lite OJ without Ca and VitD
240ml of reduced energy (lite) OJ beverage, 3 times 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.
Other Name: Minute Maid Light Orange Juice

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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, 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.
  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: NCT00386672

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
Investigators
Principal Investigator: Lee M Kaplan, MD, PhD Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Lee Kaplan MD, PhD, Director, MGH Weight Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00386672     History of Changes
Other Study ID Numbers: 2006-P-000505
Study First Received: October 6, 2006
Last Updated: January 9, 2017

Keywords provided by Lee Kaplan MD, PhD, Massachusetts General Hospital:
Calcium
Vitamin D
Weight Loss
Overweight
Obesity
Lite Orange Juice

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

ClinicalTrials.gov processed this record on August 17, 2017