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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129932
• Other study ID #: 49480215.0.0000.5149
• Status: Completed
• Phase: N/A
• Start date: January 10, 2015
• Est. completion date: December 1, 2019

Study information

• Verified date: July 2020
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• gluten phase
2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
• placebo phase
2 cakes without gluten will be consume during the 4 weeks of intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Jacqueline Isaura Alvarez Leite	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in body Weight	measured in scale presented in kg	1st, 4th and 8th weeks
Secondary	Height	measured in meters	1st week
Secondary	Changes in BMI	calculated by body weigh / square of height	1st, 4th and 8th weeks
Secondary	Changes in resting metabolic rate	measured by indirect calorimetry in kcal/kg or kcal/day	1st, 4th and 8th weeks
Secondary	Changes in macronutrient intake	calculation of food intake based on 24h diary - result in % kcal	1st, 4th and 8th weeks
Secondary	waist circumference	measured in cm	1st, 4th and 8th weeks
Secondary	Changes in IL-6 blood concentration	measure by ELISA in ug/mL	1st, 4th and 8th weeks
Secondary	Changes in IL-10	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks
Secondary	Changes in IL-1beta	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks4th and 8th weeks
Secondary	Changes in Adiponectin	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks
Secondary	Changes in Leptin	blood concentration measure by ELISA in ug/mL	1st, 4th and 8th weeks
Secondary	Changes in C reactive protein	blood concentration measure in mg/mL	1st, 4th and 8th weeks