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Effects Gluten Intake on Body Composition, Energy Expenditure and Adipokine Profile in Non-celiac Women With Obesity

J

Jacqueline Isaura Alvarez Leite

Status

Completed

Conditions

Obesity

Treatments

Dietary Supplement: gluten phase
Dietary Supplement: placebo phase

Study type

Interventional

Funder types

Other

Identifiers

NCT03129932
49480215.0.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women between 20 and 50 years without diagnosis of celiac disease
  • overweight and obese, respectively, BMI of 24.9- 34.9
  • without menopause

Exclusion criteria

  • Subjects with positive serology for celiac disease or allergy to wheat

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

40 participants in 2 patient groups, including a placebo group

gluten phase
Active Comparator group
Description:
volunteers will receive 2 corn muffins containing12g of gluten/muffin to be consumed daily for 4 weeks
Treatment:
Dietary Supplement: gluten phase
Placebo phase
Placebo Comparator group
Description:
volunteers will receive 2 corn muffins without gluten/muffin to be consumed daily for 4 weeks
Treatment:
Dietary Supplement: placebo phase

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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