ObesityCaSHeWNCT01363115
Calcium Supplementation for a Healthy Weight (CaSHeW)
A study testing Orange Juice fortified with Calcium and Vitamin D, Orange juice without Ca or VitD and Nutritional Counseling in people with Obesity and Overweight, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Orange Juice fortified with Calcium and Vitamin D, Orange juice without Ca or VitD and Nutritional Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Weight Center
Boston, Massachusetts, 02114
About this study
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.
Read the 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):
- Regular OJ: one 8 fluid oz serving three times/day (control)
- 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
- Conditions
- Obesity, Overweight
- Being tested
- Orange Juice fortified with Calcium and Vitamin D, Orange juice without Ca or VitD, Nutritional Counseling
- Keywords
- Body Weight, Dietary Supplement, Calcium, Vitamin D
- Medical subject headings
- Obesity, Overweight, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange Juice fortified with Calcium and Vitamin DDietary supplement
Also called Minute Maid regular calorie orange juice
Three 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving
Orange juice without Ca or VitDDietary supplement
Also called Minute Maid regular calorie orange juice
Three 240 mL glasses of orange juice without Ca or VitD
Nutritional CounselingBehavioural
Individual and group nutritional counseling by a registered dietitian
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Dietary Supplement: Orange juice without Ca or VitD; Behavioral: Nutritional Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline and 16 weeks
Secondary outcomes (2)
Change in visceral adipose tissue mass
Measured: Baseline and 16 weeks
Change in subcutaneous adipose tissue mass
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startJul 2005
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Beverage Institute for Health & Wellness
- Investigators
- Lee M Kaplan, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363115
- Sponsor's protocol ID
- 2005-P-000414
- Acronym
- CaSHeW
- Status last verified
- May 2011
- First submitted
- 26 May 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22170363
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Supplementation for a Healthy Weight (CaSHeW)
- ClinicalTrials.gov ID
- NCT01363115
- Acronym / sponsor ID
- CaSHeW / 2005-P-000414
- Conditions
- Obesity, Overweight
- Keywords
- Body Weight, Dietary Supplement, Calcium, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Beverage Institute for Health & Wellness
- Study start
- Jul 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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):
- Regular OJ: one 8 fluid oz serving three times/day (control)
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OJ fortified with Ca and VitD | Experimental | Dietary Supplement: Orange Juice fortified with Calcium and Vitamin D, Behavioral: Nutritional CounselingRegular 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 |
| OJ without VitD and Ca | Active comparator | Dietary Supplement: Orange juice without Ca or VitD, Behavioral: Nutritional CounselingRegular OJ without Calcium or Vitamin D3: one 8 fluid oz serving three times/day (control) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange Juice fortified with Calcium and Vitamin DAlso: Minute Maid regular calorie orange juiceThree 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving | Dietary supplement | OJ fortified with Ca and VitD |
| Orange juice without Ca or VitDAlso: Minute Maid regular calorie orange juiceThree 240 mL glasses of orange juice without Ca or VitD | Dietary supplement | OJ without VitD and Ca |
| Nutritional CounselingIndividual and group nutritional counseling by a registered dietitian | Behavioural | OJ fortified with Ca and VitD, OJ without VitD and Ca |
Primary outcome
Change in body weight
Time frame: Baseline and 16 weeks
2 secondary outcomes
Change in visceral adipose tissue mass
Time frame: Baseline and 16 weeks
Change in subcutaneous adipose tissue mass
Time frame: Baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Derived from this study: PubMed 22170363Rosenblum 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.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee M Kaplan, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange Juice fortified with Calcium and Vitamin D, Orange juice without Ca or VitD and Nutritional Counseling in people with Obesity and Overweight, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01363115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.