ObesityNCT03129932
Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
A study testing gluten phase in people with Obesity, run by Jacqueline Isaura Alvarez Leite.
Trial summary
This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- gluten phase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2015to 1 Dec 2019
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between 20 and 50 years without diagnosis of celiac disease
- overweight and obese, respectively, BMI of 24.9- 34.9
- without menopause
Who cannot join
- Subjects with positive serology for celiac disease or allergy to wheat
About this study
Official title: Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th experimental weeks will be evaluated body weight, body composition, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers.
Read the detailed description
It is a double-masked, crossover, randomized, controlled study. For this, volunteers will be kept on gluten-free diet for 8 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of food consumption and daily intake of gluten. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). After that, volunteers will be transferred for the other phase for 4 more weeks. During the 8 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. At the 1st, 4th and 8th experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be submitted to indirect calorimetry, electrical bioimpedance, blood collection and anthropometry (weight and height). The volunteers will also respond a questionnaire about life habits, family history, previous history, physical activity and food frequency. Blood samples will be used to assess blood count, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers (soluble VCAM, C-reactive protein, fibrinogen). Four weeks after the end of the experiment, and return to the alimentary routine, body weight, blood sample, calorimetry and bioimpedance will be reassessed.
- Conditions
- Obesity
- Being tested
- gluten phase, placebo phase
- Keywords
- gluten, adipokine, obesity, diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gluten phaseDietary supplement
2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
placebo phaseDietary supplement
2 cakes without gluten will be consume during the 4 weeks of intervention
| Study group | Role | What they receive |
|---|---|---|
| gluten phase | Active comparator | volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks Receives: Dietary Supplement: gluten phase |
| Placebo phase | Placebo comparator | volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks Receives: Dietary Supplement: placebo phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body Weight
measured in scale presented in kg
Measured: 1st, 4th and 8th weeks
Secondary outcomes (11)
Height
measured in meters
Measured: 1st week
Changes in BMI
calculated by body weigh / square of height
Measured: 1st, 4th and 8th weeks
Changes in resting metabolic rate
measured by indirect calorimetry in kcal/kg or kcal/day
Measured: 1st, 4th and 8th weeks
Changes in macronutrient intake
calculation of food intake based on 24h diary - result in % kcal
Measured: 1st, 4th and 8th weeks
waist circumference
measured in cm
Measured: 1st, 4th and 8th weeks
Changes in IL-6 blood concentration
measure by ELISA in ug/mL
Measured: 1st, 4th and 8th weeks
Changes in IL-10
blood concentration measure by ELISA in ug/mL
Measured: 1st, 4th and 8th weeks
Changes in IL-1beta
blood concentration measure by ELISA in ug/mL
Measured: 1st, 4th and 8th weeks4th and 8th weeks
Changes in Adiponectin
blood concentration measure by ELISA in ug/mL
Measured: 1st, 4th and 8th weeks
Changes in Leptin
blood concentration measure by ELISA in ug/mL
Measured: 1st, 4th and 8th weeks
Changes in C reactive protein
blood concentration measure in mg/mL
Measured: 1st, 4th and 8th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start10 Jan 2015
- Primary completion1 Sep 2019
- Study completion1 Dec 2019
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
- Model description
- double-masked, crossover, randomized, controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacqueline Isaura Alvarez Leite
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Sponsor-investigator, Jacqueline Isaura Alvarez Leite, Federal University of Minas Gerais
- Investigators
- JAQUELINE I ALVAREZ-LEITE, MD, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129932
- Sponsor's protocol ID
- 49480215.0.0000.5149
- Status last verified
- Jul 2020
- First submitted
- 21 Apr 2017
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Gluten on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity
- ClinicalTrials.gov ID
- NCT03129932
- Acronym / sponsor ID
- 49480215.0.0000.5149
- Conditions
- Obesity
- Keywords
- gluten, adipokine, obesity, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jacqueline Isaura Alvarez LeiteUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 10 Jan 2015 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 26 Apr 2017 (actual)
- 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.
This is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). At the 1st, 4th and 8th experimental weeks will be evaluated body weight, body composition, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers.
Detailed description
It is a double-masked, crossover, randomized, controlled study. For this, volunteers will be kept on gluten-free diet for 8 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of food consumption and daily intake of gluten. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (Placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (Gluten phase). After that, volunteers will be transferred for the other phase for 4 more weeks. During the 8 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. At the 1st, 4th and 8th experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be submitted to indirect calorimetry, electrical bioimpedance, blood collection and anthropometry (weight and height). The volunteers will also respond a questionnaire about life habits, family history, previous history, physical activity and food frequency. Blood samples will be used to assess blood count, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers (soluble VCAM, C-reactive protein, fibrinogen). Four weeks after the end of the experiment, and return to the alimentary routine, body weight, blood sample, calorimetry and bioimpedance will be reassessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double-masked, crossover, randomized, controlled study
| Arm | Type | Receives |
|---|---|---|
| gluten phase | Active comparator | Dietary Supplement: gluten phasevolunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks |
| Placebo phase | Placebo comparator | Dietary Supplement: placebo phasevolunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between 20 and 50 years without diagnosis of celiac disease
- overweight and obese, respectively, BMI of 24.9- 34.9
- without menopause
Key exclusion criteria (1 listed)
- Subjects with positive serology for celiac disease or allergy to wheat
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 |
|---|---|---|
| gluten phase2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention | Dietary supplement | gluten phase |
| placebo phase2 cakes without gluten will be consume during the 4 weeks of intervention | Dietary supplement | Placebo phase |
Primary outcome
Changes in body Weight
Time frame: 1st, 4th and 8th weeks
measured in scale presented in kg
11 secondary outcomes
Height
Time frame: 1st week
Changes in BMI
Time frame: 1st, 4th and 8th weeks
Changes in resting metabolic rate
Time frame: 1st, 4th and 8th weeks
Changes in macronutrient intake
Time frame: 1st, 4th and 8th weeks
waist circumference
Time frame: 1st, 4th and 8th weeks
Changes in IL-6 blood concentration
Time frame: 1st, 4th and 8th weeks
Changes in IL-10
Time frame: 1st, 4th and 8th weeks
Changes in IL-1beta
Time frame: 1st, 4th and 8th weeks4th and 8th weeks
Changes in Adiponectin
Time frame: 1st, 4th and 8th weeks
Changes in Leptin
Time frame: 1st, 4th and 8th weeks
Changes in C reactive protein
Time frame: 1st, 4th and 8th 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 31 Jul 2020.
- Individual participant dataSharing planned: No
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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.
JAQUELINE I ALVAREZ-LEITE, MD, PhD principal investigator
Federal University of Minas Gerais
Questions about this trial
What is this clinical trial studying?
A study testing gluten phase in people with Obesity, run by Jacqueline Isaura Alvarez Leite.
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 1 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Changes in body Weight (time frame: 1st, 4th and 8th weeks). 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 31 Jul 2020.