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

NCT03129997 | Completed DMC

• 1 other identifier: 49480215000005149H
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in body Weight

  measured in scale presented in kg

  1st, 3rd and 6th weeks

Secondary Outcomes (5)

• Changes in resting metabolic rate

  1st, 3rd and 6th weeks

• Changes in macronutrient intake

  1st, 3rd and 6th weeks

• waist circumference

  1st, 3rd and 6th weeks

• Height

  1st week

• BMI

  1st, 3rd and 6th weeks

Study Arms (2)

Gluten test food

ACTIVE COMPARATOR

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

Placebo test food

PLACEBO COMPARATOR

volunteers will receive 2 corn based muffins to be consumed daily in any meal for 3 weeks

Dietary Supplement: Gluten test food

Interventions

Gluten test food DIETARY_SUPPLEMENT

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

Gluten test food; Placebo test food

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JAQUELINE I ALVAREZ-LEITE

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,Ph.D

Model Details: crossover double masked model

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: March 3, 2016
• Primary Completion: December 2, 2016
• Study Completion: March 3, 2017
• Last Updated: April 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share