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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Gluten test food

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gluten test food; volunteers will receive 2 corn based muffins containing 7,5g of gluten/muffin to be consumed daily for 3 weeks	Dietary supplement: Gluten test food; Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days
Placebo Comparator: Placebo test food; volunteers will receive 2 corn based muffins to be consumed daily in any meal for 3 weeks	Dietary supplement: Gluten test food; Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body Weight	measured in scale presented in kg	1st, 3rd and 6th weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	measured in meters	1st week
Changes in resting metabolic rate	measured by indirect calorimetry in kcal/kg or kcal/day	1st, 3rd and 6th weeks
Changes in macronutrient intake	calculation of food intake based on 24h diary - result in % kcal	1st, 3rd and 6th weeks
waist circumference	measured in cm	1st, 3rd and 6th weeks
BMI	calculated by body weigh / square of height	1st, 3rd and 6th weeks

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: JAQUELINE I ALVAREZ-LEITE, Federal University of Minas Gerais

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2016
• Primary Completion (Actual): December 2, 2016
• Study Completion (Actual): March 3, 2017

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 49480215000005149H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No