Investigating the Early Markers of Weight Loss

NCT04866875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-30

No results posted yet for this study

Summary

The study will include 30 women randomized in two distinct groups: G1: Slow weight loss and G2: Rapid weight loss . The total duration of the program will be different for each group, being over 20 and 10 weeks for G1 and G2, respectively, in attempt to match the groups on amount of weight loss (approximately 20 pounds per subject). Participants who meet the inclusion criteria will be randomized to rapid or slow weight loss groups. The energy deprivation of the rapid and slow weight loss will be in -1000 kcal/day and -500 kcal/day, respectively. Calculated based on the baseline resting energy expenditure (REE; determined by indirect calorimetry) and their physical activity level measured for one week. The diet macronutrient composition will be personalized for each participant based on the results of 2-day energy intake at preliminary session, measured with food items selected from a validated food menu. Individuals will be instructed to maintain the level of energy restriction and macronutrient composition during the diet period, however they will be able to do food exchanges, based on the Canadian Diabetes Association system. It will be measured participant's body weight, body compositions, appetite sensations, resting energy expenditure, energy intake, palatability, olfactory performance, food reward, food reinforcement and impulsivity. Participants will have 7 sessions in total: 1 preliminary, baseline, 7 days of intervention, 3 follow ups and final assessment.

Conditions

Interventions

BEHAVIORAL

dieting

The minimum amount of caloric intake will be pre-set in 1200 kcal for the both groups, in order to avoid micronutrient deficiencies during the intervention. The diet macronutrient composition will be personalized for each participant based on the results of 2-day energy intake at preliminary session, measured with food items selected from a validated food menu. Individuals will be instructed to maintain the level of energy restriction and macronutrient composition during the diet period, however they will be able to do food exchanges, based on the Canadian Diabetes Association system . This method allows individuals to select foods they enjoy during the weight loss, however in smaller quantities.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV
  • University of Ottawa

    lead OTHER

Principal Investigators

  • Eric Doucet, PhD · Universiy of Ottawa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-01
Primary Completion
2017-01-02
Completion
2018-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04866875 on ClinicalTrials.gov