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Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women

Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03129997
Enrollment
30
Registered
2017-04-26
Start date
2016-03-03
Completion date
2017-03-03
Last updated
2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

The objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on body weight, basal metabolic rate and macronutrient intake. In a crossover double masked model, 30 volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks.

Detailed description

The objective is to evaluate in eutrophic women the impact of intake of moderate amounts of wheat gluten on body weight basal metabolic rate and possible relation to macronutrient intake. For this, 30 volunteers will kept on a restricted diet in gluten-free foods of 6 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 24-hour food register, to evaluate the average food and gluten daily intake. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks. During these 6 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. The test food (gluten and placebo muffins) will be produced in the Laboratory of Dietetic Technique of the School of Nursing of the Federal University of Minas Gerais and delivered weekly to each volunteer. Placebo test foods is a corn-based muffin of about 45g. In the Gluten muffins, 10g of corn is replaced by 10g of gluten (corresponding to 7.5g of gluten protein). Each volunteer will be instructed to take 2 (placebo or gluten) muffin/day. To evaluate diet adherence and signs and symptoms of intolerances, volunteers will fill a questionnaire weekly, informing about the consumption of the test food, eventual intake of food containing gluten, and the presence of gastrointestinal signs and symptoms such as constipation, diarrhea, nausea or vomiting etc.

Interventions

DIETARY_SUPPLEMENTGluten test food

Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
CollaboratorOTHER_GOV
Federal University of Minas Gerais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Masking description

volunteers received placebo or gluten corn muffins that are similar in taste and appearance. Investigator does not know who is receiving placebo or gluten muffins. During analyses, each sample is coded to avoid volunteer or phase identification.

Intervention model description

crossover double masked model

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Women aged between 18 and 40 * Body Mass Index (BMI) between 18.5 and 24.9 kg / m² * Sign of informed consent * Absence of associated chronic diseases

Exclusion criteria

* Postmenopausal patients * Onset of chronic medication * discontinuance of test food intake for 2or more days * Do not attend 2 of the 3 meetings.

Design outcomes

Primary

MeasureTime frameDescription
Changes in body Weight1st, 3rd and 6th weeksmeasured in scale presented in kg

Secondary

MeasureTime frameDescription
Changes in resting metabolic rate1st, 3rd and 6th weeksmeasured by indirect calorimetry in kcal/kg or kcal/day
Changes in macronutrient intake1st, 3rd and 6th weekscalculation of food intake based on 24h diary - result in % kcal
waist circumference1st, 3rd and 6th weeksmeasured in cm
Height1st weekmeasured in meters
BMI1st, 3rd and 6th weekscalculated by body weigh / square of height

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026