ObesityNCT00386672
Calcium Supplementation for a Healthy Weight-Lite (CaSHeW Lite)
A study testing Reduced energy (lite) OJ fortified with Calcium and Vitamin D, Nutrition Counseling and Reduced energy (lite) OJ without Calcium and Vitamin D in people with Obesity and Overweight, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. 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?
- Reduced energy (lite) OJ fortified with Calcium and Vitamin D, Nutrition Counseling and Reduced energy (lite) OJ without Calcium and Vitamin D
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to 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, 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.
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- 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. (see Appendix 1 for detailed list)
- Active eating disorder.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Weight Center
Boston, Massachusetts, 02114
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Reduced energy (lite) OJ fortified with Calcium and Vitamin D, Nutrition Counseling, Reduced energy (lite) OJ without Calcium and Vitamin D
- Keywords
- Calcium, Vitamin D, Weight Loss, Overweight, Obesity, Lite Orange Juice
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced energy (lite) OJ fortified with Calcium and Vitamin DDietary supplement
Also called Minute Maid Light Orange Juice
Three 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day.
Nutrition CounselingBehavioural
Individual and group nutritional counseling by a registered dietician.
Reduced energy (lite) OJ without Calcium and Vitamin DDietary supplement
Also called Minute Maid Light Orange Juice
Three 240ml servings of lite OJ without 350mg Ca and 100U VitD per day.
| Study group | Role | What they receive |
|---|---|---|
| Lite OJ with Ca and VitD | Experimental | 240ml of reduced energy (lite) OJ beverage fortified with 350mg Ca and 100U VitD, 3 times per day. Receives: Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D; Behavioral: Nutrition Counseling |
| Lite OJ without Ca and VitD | Active comparator | 240ml of reduced energy (lite) OJ beverage, 3 times per day. Receives: Behavioral: Nutrition Counseling; Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline and at 16 weeks
Secondary outcomes (2)
Change in visceral adipose tissue mass
Measured: Baseline and at 16 weeks
Change in subcutaneous adipose tissue mass
Measured: Baseline and at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Beverage Institute for Health & Wellness
- Responsible party
- Principal investigator, Lee Kaplan MD, PhD, Massachusetts General Hospital
- Investigators
- Lee M Kaplan, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386672
- Sponsor's protocol ID
- 2006-P-000505
- Status last verified
- Jan 2017
- First submitted
- 6 Oct 2006
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
PubMed 10546691Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Obes Res. 1998 Mar;6(2):97-106. doi: 10.1002/j.1550-8528.1998.tb00322.x.
PubMed 9545015Davies KM, Heaney RP, Recker RR, Lappe JM, Barger-Lux MJ, Rafferty K, Hinders S. Calcium intake and body weight. J Clin Endocrinol Metab. 2000 Dec;85(12):4635-8. doi: 10.1210/jcem.85.12.7063.
PubMed 11134120Jacqmain M, Doucet E, Despres JP, Bouchard C, Tremblay A. Calcium intake, body composition, and lipoprotein-lipid concentrations in adults. Am J Clin Nutr. 2003 Jun;77(6):1448-52. doi: 10.1093/ajcn/77.6.1448.
PubMed 12791622Zemel MB. Regulation of adiposity and obesity risk by dietary calcium: mechanisms and implications. J Am Coll Nutr. 2002 Apr;21(2):146S-151S. doi: 10.1080/07315724.2002.10719212.
PubMed 11999543Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of adiposity by dietary calcium. FASEB J. 2000 Jun;14(9):1132-8.
PubMed 10834935Shi H, Norman AW, Okamura WH, Sen A, Zemel MB. 1alpha,25-Dihydroxyvitamin D3 modulates human adipocyte metabolism via nongenomic action. FASEB J. 2001 Dec;15(14):2751-3. doi: 10.1096/fj.01-0584fje. Epub 2001 Oct 15.
PubMed 11606486Zemel MB. Role of dietary calcium and dairy products in modulating adiposity. Lipids. 2003 Feb;38(2):139-46. doi: 10.1007/s11745-003-1044-6.
PubMed 12733746Shi H, Dirienzo D, Zemel MB. Effects of dietary calcium on adipocyte lipid metabolism and body weight regulation in energy-restricted aP2-agouti transgenic mice. FASEB J. 2001 Feb;15(2):291-3. doi: 10.1096/fj.00-0584fje. Epub 2000 Dec 8.
PubMed 11156940Ye WZ, Reis AF, Dubois-Laforgue D, Bellanne-Chantelot C, Timsit J, Velho G. Vitamin D receptor gene polymorphisms are associated with obesity in type 2 diabetic subjects with early age of onset. Eur J Endocrinol. 2001 Aug;145(2):181-6. doi: 10.1530/eje.0.1450181.
PubMed 11454514Barger-Lux MJ, Heaney RP, Hayes J, DeLuca HF, Johnson ML, Gong G. Vitamin D receptor gene polymorphism, bone mass, body size, and vitamin D receptor density. Calcif Tissue Int. 1995 Aug;57(2):161-2. doi: 10.1007/BF00298438.
PubMed 7584878Bell NH, Epstein S, Greene A, Shary J, Oexmann MJ, Shaw S. Evidence for alteration of the vitamin D-endocrine system in obese subjects. J Clin Invest. 1985 Jul;76(1):370-3. doi: 10.1172/JCI111971.
PubMed 2991340Liel Y, Ulmer E, Shary J, Hollis BW, Bell NH. Low circulating vitamin D in obesity. Calcif Tissue Int. 1988 Oct;43(4):199-201. doi: 10.1007/BF02555135.
PubMed 3145124Shi H, Norman AW, Okamura WH, Sen A, Zemel MB. 1alpha,25-dihydroxyvitamin D3 inhibits uncoupling protein 2 expression in human adipocytes. FASEB J. 2002 Nov;16(13):1808-10. doi: 10.1096/fj.02-0255fje. Epub 2002 Sep 5.
PubMed 12223452Sun X, Zemel MB. Role of uncoupling protein 2 (UCP2) expression and 1alpha, 25-dihydroxyvitamin D3 in modulating adipocyte apoptosis. FASEB J. 2004 Sep;18(12):1430-2. doi: 10.1096/fj.04-1971fje. Epub 2004 Jul 1.
PubMed 15231722
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Supplementation for a Healthy Weight- LITE
- ClinicalTrials.gov ID
- NCT00386672
- Acronym / sponsor ID
- 2006-P-000505
- Conditions
- Obesity, Overweight
- Keywords
- Calcium, Vitamin D, Weight Loss, Overweight, Obesity, Lite Orange Juice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Beverage Institute for Health & Wellness
- Study start
- May 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 11 Oct 2006 (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 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.
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 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 |
|---|---|---|
| Lite OJ with Ca and VitD | Experimental | Dietary Supplement: Reduced energy (lite) OJ fortified with Calcium and Vitamin D, Behavioral: Nutrition Counseling240ml of reduced energy (lite) OJ beverage fortified with 350mg Ca and 100U VitD, 3 times per day. |
| Lite OJ without Ca and VitD | Active comparator | Behavioral: Nutrition Counseling, Dietary Supplement: Reduced energy (lite) OJ without Calcium and Vitamin D240ml of reduced energy (lite) OJ beverage, 3 times per day. |
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, Endocrinology) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator.
Key exclusion criteria (12 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. (see Appendix 1 for detailed list)
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 |
|---|---|---|
| Reduced energy (lite) OJ fortified with Calcium and Vitamin DAlso: Minute Maid Light Orange JuiceThree 240ml servings of lite OJ fortified with 350mg Ca and 100U VitD per day. | Dietary supplement | Lite OJ with Ca and VitD |
| Nutrition CounselingIndividual and group nutritional counseling by a registered dietician. | Behavioural | Lite OJ with Ca and VitD, Lite OJ without Ca and VitD |
| Reduced energy (lite) OJ without Calcium and Vitamin DAlso: Minute Maid Light Orange JuiceThree 240ml servings of lite OJ without 350mg Ca and 100U VitD per day. | Dietary supplement | Lite OJ without Ca and VitD |
Primary outcome
Change in body weight
Time frame: Baseline and at 16 weeks
2 secondary outcomes
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
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 10 Jan 2017.
- Background: PubMed 10546691Must A, Spadano J, Coakley EH, Field AE, Colditz G, Dietz WH. The disease burden associated with overweight and obesity. JAMA. 1999 Oct 27;282(16):1523-9. doi: 10.1001/jama.282.16.1523.
- Background: PubMed 9545015Wolf AM, Colditz GA. Current estimates of the economic cost of obesity in the United States. Obes Res. 1998 Mar;6(2):97-106. doi: 10.1002/j.1550-8528.1998.tb00322.x.
- Background: PubMed 11134120Davies KM, Heaney RP, Recker RR, Lappe JM, Barger-Lux MJ, Rafferty K, Hinders S. Calcium intake and body weight. J Clin Endocrinol Metab. 2000 Dec;85(12):4635-8. doi: 10.1210/jcem.85.12.7063.
- Background: PubMed 12791622Jacqmain M, Doucet E, Despres JP, Bouchard C, Tremblay A. Calcium intake, body composition, and lipoprotein-lipid concentrations in adults. Am J Clin Nutr. 2003 Jun;77(6):1448-52. doi: 10.1093/ajcn/77.6.1448.
- Background: PubMed 11999543Zemel MB. Regulation of adiposity and obesity risk by dietary calcium: mechanisms and implications. J Am Coll Nutr. 2002 Apr;21(2):146S-151S. doi: 10.1080/07315724.2002.10719212.
- Background: PubMed 10834935Zemel MB, Shi H, Greer B, Dirienzo D, Zemel PC. Regulation of adiposity by dietary calcium. FASEB J. 2000 Jun;14(9):1132-8.
- Background: PubMed 11606486Shi H, Norman AW, Okamura WH, Sen A, Zemel MB. 1alpha,25-Dihydroxyvitamin D3 modulates human adipocyte metabolism via nongenomic action. FASEB J. 2001 Dec;15(14):2751-3. doi: 10.1096/fj.01-0584fje. Epub 2001 Oct 15.
- Background: PubMed 12733746Zemel MB. Role of dietary calcium and dairy products in modulating adiposity. Lipids. 2003 Feb;38(2):139-46. doi: 10.1007/s11745-003-1044-6.
- Background: PubMed 11156940Shi H, Dirienzo D, Zemel MB. Effects of dietary calcium on adipocyte lipid metabolism and body weight regulation in energy-restricted aP2-agouti transgenic mice. FASEB J. 2001 Feb;15(2):291-3. doi: 10.1096/fj.00-0584fje. Epub 2000 Dec 8.
- Background: PubMed 11454514Ye WZ, Reis AF, Dubois-Laforgue D, Bellanne-Chantelot C, Timsit J, Velho G. Vitamin D receptor gene polymorphisms are associated with obesity in type 2 diabetic subjects with early age of onset. Eur J Endocrinol. 2001 Aug;145(2):181-6. doi: 10.1530/eje.0.1450181.
- Background: PubMed 7584878Barger-Lux MJ, Heaney RP, Hayes J, DeLuca HF, Johnson ML, Gong G. Vitamin D receptor gene polymorphism, bone mass, body size, and vitamin D receptor density. Calcif Tissue Int. 1995 Aug;57(2):161-2. doi: 10.1007/BF00298438.
- Background: PubMed 2991340Bell NH, Epstein S, Greene A, Shary J, Oexmann MJ, Shaw S. Evidence for alteration of the vitamin D-endocrine system in obese subjects. J Clin Invest. 1985 Jul;76(1):370-3. doi: 10.1172/JCI111971.
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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 Reduced energy (lite) OJ fortified with Calcium and Vitamin D, Nutrition Counseling and Reduced energy (lite) OJ without Calcium and Vitamin D 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 12 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 10 Jan 2017. 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 at 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 NCT00386672, which also lists 20 linked publications.
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 10 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.