Weight LossNCT00472680
The Effect of Severe Weight Loss and Protein Intake on Bone
A study testing Caloric restriction, high protein, Caloric restriction; normal protein and Nutrition Education in people with Weight Loss, run by Rutgers University at 1 site in United States.
Trial summary
The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Weight Loss
- What is being tested?
- Caloric restriction, high protein, Caloric restriction; normal protein and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2016
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 18 to 70 who are undergoing gastric bypass surgery
- Must live in the geographic vicinity of Rutgers University
Who cannot join
- Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease [i.e., heart attack or stroke in the past 6 months., abnormal EKG], active malignancy or cancer therapy within the past year)
- History of kidney stones
- Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
- Participation in other investigational studies during the 12-month study period
- Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Regulation of Bone - Aim 2
The purpose of this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.
Read the detailed description
It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover, mass and quality in women, with the hypothesis that higher protein intake will reduce bone turnover and loss, and/or prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years.
Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, or B) weight loss with higher protein intake. A dietitian will provide instructions for a reduced calorie, well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program. Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month. In addition they will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density).
- Conditions
- Weight Loss
- Being tested
- Caloric restriction, high protein, Caloric restriction; normal protein, Nutrition Education
- Keywords
- bone mass, calcium absorption, bone quality, fracture risk
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric restriction, high proteinBehavioural
Weight loss with higher protein (35%) intake
Caloric restriction; normal proteinBehavioural
Weight loss with normal level of protein (18%) intake
Nutrition EducationBehavioural
Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High Dietary Protein Receives: Behavioral: Caloric restriction, high protein; Behavioral: Nutrition Education |
| 2 | Active comparator | Normal Dietary Protein Receives: Behavioral: Caloric restriction; normal protein; Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Bone mineral density and quality
Measured: one year
Secondary outcomes (1)
Changes in serum and urine bone markers, hormones, and proteins
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2007 (estimated)
- Study startMar 2010
- Primary completionMay 2015
- Study completionJan 2016
Why it stopped: Funding didn't support further recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Sue A. Shapses, Ph.D., RD, Rutgers University
- Investigators
- Sue A. Shapses, PhD, RD, Principal investigator, Rutgers University, Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472680
- Sponsor's protocol ID
- AG0082
- Other IDs
- 5R01AG012161
- Status last verified
- Jan 2022
- First submitted
- 10 May 2007
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453.
PubMed 16702302Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29.
PubMed 15746990Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7.
PubMed 14742841Riedt CS, Brolin RE, Sherrell RM, Field MP, Shapses SA. True fractional calcium absorption is decreased after Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2006 Nov;14(11):1940-8. doi: 10.1038/oby.2006.226.
PubMed 17135609Sukumar D, Ambia-Sobhan H, Zurfluh R, Schlussel Y, Stahl TJ, Gordon CL, Shapses SA. Areal and volumetric bone mineral density and geometry at two levels of protein intake during caloric restriction: a randomized, controlled trial. J Bone Miner Res. 2011 Jun;26(6):1339-48. doi: 10.1002/jbmr.318.
PubMed 21611972Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.
PubMed 35538903
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Regulation of Bone - Aim 2
- ClinicalTrials.gov ID
- NCT00472680
- Acronym / sponsor ID
- AG0082
- Conditions
- Weight Loss
- Keywords
- bone mass, calcium absorption, bone quality, fracture risk
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding didn't support further recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rutgers UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Mar 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 May 2007 (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 this study is to learn whether the amount of dietary protein can influence bone health during the weight loss after weight loss surgery.
Detailed description
It is unclear whether the amount of protein in the diet during caloric restriction influences bone density. This information is important for determining optimal nutrient requirements during weight loss. This study will examine usual and higher dietary protein intake during severe weight loss following weight loss surgery on bone turnover, mass and quality in women, with the hypothesis that higher protein intake will reduce bone turnover and loss, and/or prevent the changes in bone quality associated with severe weight loss in women ages 18 to 70 years.
Participants will be randomly assigned to one of 2 groups: A) weight loss with recommended level of protein intake, or B) weight loss with higher protein intake. A dietitian will provide instructions for a reduced calorie, well balanced diet throughout the 12-month study using a nutrition-education behavior- modification program. Participants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month. In addition they will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. Bone, mineral, protein and lipid markers, and hormones that influence bones will be measured. These measurements will provide information about body composition (fat, muscle mass, and bone mineral density).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Caloric restriction, high protein, Behavioral: Nutrition EducationHigh Dietary Protein |
| 2 | Active comparator | Behavioral: Caloric restriction; normal protein, Behavioral: Nutrition EducationNormal Dietary Protein |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women ages 18 to 70 who are undergoing gastric bypass surgery
- Must live in the geographic vicinity of Rutgers University
Key exclusion criteria (5 listed)
- Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease [i.e., heart attack or stroke in the past 6 months., abnormal EKG], active malignancy or cancer therapy within the past year)
- History of kidney stones
- Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
- Participation in other investigational studies during the 12-month study period
- Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
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 |
|---|---|---|
| Caloric restriction, high proteinWeight loss with higher protein (35%) intake | Behavioural | 1 |
| Caloric restriction; normal proteinWeight loss with normal level of protein (18%) intake | Behavioural | 2 |
| Nutrition EducationParticipants will have the opportunity to speak with the dietitian about their diet by phone, or on-site twice per month | Behavioural | 1, 2 |
Primary outcome
Changes in Bone mineral density and quality
Time frame: one year
1 secondary outcome
Changes in serum and urine bone markers, hormones, and proteins
Time frame: one year
Results and safety
The study was stopped early (reason given: Funding didn't support further recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 16702302Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453.
- Background: PubMed 15746990Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29.
- Background: PubMed 14742841Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7.
- Background: PubMed 17135609Riedt CS, Brolin RE, Sherrell RM, Field MP, Shapses SA. True fractional calcium absorption is decreased after Roux-en-Y gastric bypass surgery. Obesity (Silver Spring). 2006 Nov;14(11):1940-8. doi: 10.1038/oby.2006.226.
- Background: PubMed 21611972Sukumar D, Ambia-Sobhan H, Zurfluh R, Schlussel Y, Stahl TJ, Gordon CL, Shapses SA. Areal and volumetric bone mineral density and geometry at two levels of protein intake during caloric restriction: a randomized, controlled trial. J Bone Miner Res. 2011 Jun;26(6):1339-48. doi: 10.1002/jbmr.318.
- Derived from this study: PubMed 35538903Ogilvie AR, Schlussel Y, Sukumar D, Meng L, Shapses SA. Higher protein intake during caloric restriction improves diet quality and attenuates loss of lean body mass. Obesity (Silver Spring). 2022 Jul;30(7):1411-1419. doi: 10.1002/oby.23428. Epub 2022 May 11.
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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.
Sue A. Shapses, PhD, RD principal investigator
Rutgers University, Nutritional Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric restriction, high protein, Caloric restriction; normal protein and Nutrition Education in people with Weight Loss, run by Rutgers University 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 2 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Feb 2022. 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 was stopped early (reason given: Funding didn't support further recruitment). Results are not available in the source record.
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?
Changes in Bone mineral density and quality (time frame: one year). 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 NCT00472680, which also lists 6 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 1 Feb 2022.