Calcium Supplementation for a Healthy Weight-Lite (CaSHeW Lite)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00386672|
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : January 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Calcium Supplementation for a Healthy Weight- LITE|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
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 JuiceBehavioral: 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
- Change in body weight [ Time Frame: Baseline and at 16 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386672
|United States, Massachusetts|
|Massachusetts General Hospital Weight Center|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Lee M Kaplan, MD, PhD||Massachusetts General Hospital|