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

January 9, 2017 updated by: Lee Kaplan MD, PhD, Massachusetts General Hospital

Calcium Supplementation for a Healthy Weight- LITE

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Weight Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Minute Maid Light Orange Juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: Baseline and at 16 weeks
Baseline and at 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in visceral adipose tissue mass
Time Frame: Baseline and at 16 weeks
Baseline and at 16 weeks
Change in subcutaneous adipose tissue mass
Time Frame: Baseline and at 16 weeks
Baseline and at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

The Beverage Institute for Health and Wellness

Investigators

  • Principal Investigator: Lee M Kaplan, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 6, 2006

First Submitted That Met QC Criteria

October 10, 2006

First Posted (Estimate)

October 11, 2006

Study Record Updates

Last Update Posted (Estimate)

January 10, 2017

Last Update Submitted That Met QC Criteria

January 9, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-P-000505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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