ObesityNCT00948038
Dairy Modulation of Oxidative and Inflammatory Stress in Overweight and Obese Subjects
A study testing Milk and Soy in people with Obesity and Overweight, run by University of Tennessee at 1 site in United States.
Trial summary
The objective of this study is to determine the acute effects of a dairy supplement compared to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Milk and Soy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to May 2009
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 25-29.9 (n=10); 30-34.9 kg/m2 (n=10)
- Age 18-50 years
- Weight stable: no more than 3 kg weight loss during past three months
Who cannot join
- BMI < 25 or >35
- Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
- Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
- history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
- history of eating disorder
- presence of active gastrointestinal disorders such as malabsorption syndromes
Show all 14Show fewer
- pregnancy or lactation
- use of obesity pharmacotherapeutic agents within the last 6 months
- use of over-the-counter anti-obesity agents (e.g. those containing phenylpropanalamine, ephedrine and/or caffeine) within the last 6 months
- Recent (current or past 12 weeks) use of any psychotropic medication
- Recent (past four weeks) initiation of an exercise program
- Recent (past twelve weeks) initiation of hormone replacement therapy or change in HRT regimen
- Recent (past twelve weeks) initiation of hormonal birth control or change in hormonal birth control regimen
- Recent (current or past 12 weeks) history of smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Tennessee
Knoxville, Tennessee, 37996
About this study
The objective of this study is to determine the acute effects of a dairy supplement compared to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.
Read the detailed description
Obesity is associated with sub-clinical chronic oxidative and inflammatory stress, both of which are major contributors to obesity-associated co-morbidities. Calcitriol (1, 25-(OH)2-D3) regulates adipocyte lipid metabolism, while dietary calcium inhibits obesity by suppression of calcitriol. We have recently shown calcitriol to increase oxidative stress and to stimulate the expression and release of inflammatory cytokines, while inhibiting the expression and release of anti-inflammatory cytokines. We have also shown that inhibition of calcitriol with high calcium diets decreases both adipose tissue and systemic oxidative and inflammatory stress in a mouse model of obesity. Moreover, dairy exerted a greater effect on both oxidative and inflammatory stress. These mice also exhibited significant reductions in adiposity, which could lead to confounding, as this reduction will independently reduce oxidative and inflammatory stress. However, the supporting cellular/mechanistic data indicate an effect which is independent of adiposity reduction. Consequently, we propose that low calcium diets exacerbate oxidative and inflammatory stress and that high dairy diets can attenuate both independently of changes in adiposity, thereby significantly reducing the risk of obesity-associated co-morbidities. Accordingly, the objective of this study is to determine the acute effects of a dairy-rich diet on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.
Twenty subjects (10 obese and 10 overweight) will undergo a randomized crossover study of low dairy and high dairy eucaloric diets. Each dietary period will be four weeks, and the two dietary periods will be separated by a four-week washout period. Primary outcomes will be circulating indices of oxidative stress and of inflammation. Secondary outcomes include blood pressure, circulating glucose, insulin, lipids, calcium-regulatory hormones and body composition.
- Conditions
- Obesity, Overweight
- Being tested
- Milk, Soy
- Keywords
- Inflammation, Oxidative stress
- Medical subject headings
- Obesity, Overweight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilkDietary supplement
Milk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca. Three consumed each day.
SoyDietary supplement
Soy-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate and 30 mg Ca. Three consumed each day for 28 days,
| Study group | Role | What they receive |
|---|---|---|
| Soy | Active comparator | Soy-based supplement to normal diet Receives: Dietary Supplement: Soy |
| Milk | Experimental | Milk-based supplement to normal diet Receives: Dietary Supplement: Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma malondialdehyde
Measured: 28 days
Plasma 8-isoprostane F2-alpha
Measured: 28 days
Plasma tumor necrosis factor alpha
Measured: 28 days
plasma interleukin 6
Measured: 28 days
Plasma C-reactive protein
Measured: 28 days
Plasma MCP-1
Measured: 28-days
Plasma interleukin 15
Measured: 28 days
Plasma adiponectin
Measured: 28 days
Secondary outcomes (4)
Plasma lipids
Measured: 28 days
Plasma insulin
Measured: 28 days
vitamin D
Measured: 28 days
Body composition
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948038
- Sponsor's protocol ID
- DMI-033
- Status last verified
- Jul 2009
- First submitted
- 28 Jul 2009
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Modulation of Oxidative and Inflammatory Stress in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT00948038
- Acronym / sponsor ID
- DMI-033
- Conditions
- Obesity, Overweight
- Keywords
- Inflammation, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Jul 2009 (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 determine the acute effects of a dairy supplement compared to a soy supplement on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.
Detailed description
Obesity is associated with sub-clinical chronic oxidative and inflammatory stress, both of which are major contributors to obesity-associated co-morbidities. Calcitriol (1, 25-(OH)2-D3) regulates adipocyte lipid metabolism, while dietary calcium inhibits obesity by suppression of calcitriol. We have recently shown calcitriol to increase oxidative stress and to stimulate the expression and release of inflammatory cytokines, while inhibiting the expression and release of anti-inflammatory cytokines. We have also shown that inhibition of calcitriol with high calcium diets decreases both adipose tissue and systemic oxidative and inflammatory stress in a mouse model of obesity. Moreover, dairy exerted a greater effect on both oxidative and inflammatory stress. These mice also exhibited significant reductions in adiposity, which could lead to confounding, as this reduction will independently reduce oxidative and inflammatory stress. However, the supporting cellular/mechanistic data indicate an effect which is independent of adiposity reduction. Consequently, we propose that low calcium diets exacerbate oxidative and inflammatory stress and that high dairy diets can attenuate both independently of changes in adiposity, thereby significantly reducing the risk of obesity-associated co-morbidities. Accordingly, the objective of this study is to determine the acute effects of a dairy-rich diet on oxidative and inflammatory stress in overweight and obese subjects in the absence of any changes in adiposity.
Twenty subjects (10 obese and 10 overweight) will undergo a randomized crossover study of low dairy and high dairy eucaloric diets. Each dietary period will be four weeks, and the two dietary periods will be separated by a four-week washout period. Primary outcomes will be circulating indices of oxidative stress and of inflammation. Secondary outcomes include blood pressure, circulating glucose, insulin, lipids, calcium-regulatory hormones and body composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soy | Active comparator | Dietary Supplement: SoySoy-based supplement to normal diet |
| Milk | Experimental | Dietary Supplement: MilkMilk-based supplement to normal diet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) 25-29.9 (n=10); 30-34.9 kg/m2 (n=10)
- Age 18-50 years
- Weight stable: no more than 3 kg weight loss during past three months
Key exclusion criteria (14 listed)
- BMI < 25 or >35
- Type II diabetes requiring the use of any oral antidiabetic agent and/or insulin (because of confounding effects on ROS)
- Adverse response to study foods (lactose intolerance, dairy intolerance, dairy allergy); this will be determined by self-report.
- history or presence of significant metabolic disease which could impact on the results of the study (i.e. endocrine, hepatic, renal disease)
- history of eating disorder
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 |
|---|---|---|
| MilkMilk-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate adn 350 mg Ca. Three consumed each day. | Dietary supplement | Milk |
| SoySoy-based smoothie containing 170 kcal, 10 g protein, 1 g fat, 30 g carbohydrate and 30 mg Ca. Three consumed each day for 28 days, | Dietary supplement | Soy |
Primary outcome
Plasma malondialdehyde
Time frame: 28 days
Plasma 8-isoprostane F2-alpha
Time frame: 28 days
Plasma tumor necrosis factor alpha
Time frame: 28 days
plasma interleukin 6
Time frame: 28 days
Plasma C-reactive protein
Time frame: 28 days
Plasma MCP-1
Time frame: 28-days
Plasma interleukin 15
Time frame: 28 days
Plasma adiponectin
Time frame: 28 days
4 secondary outcomes
Plasma lipids
Time frame: 28 days
Plasma insulin
Time frame: 28 days
vitamin D
Time frame: 28 days
Body composition
Time frame: 28 days
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 29 Jul 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk and Soy in people with Obesity and Overweight, run by University of Tennessee 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 3 inclusion and 14 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 29 Jul 2009. 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?
Plasma malondialdehyde (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2009.