NCT04866875

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2018

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

October 9, 2018

Last Update Submit

April 26, 2021

Conditions

Weight LossAppetitive BehaviorObesity

Keywords

energy expenditureweight lossappetiteimpulsivityfood reward

Outcome Measures

Primary Outcomes (2)

  • Change in Resting energy expenditure after weight loss

    Resting energy expenditure will be measured at baseline and in the end the intervention

    10 weeks

  • Change in Resting energy expenditure after weight loss

    Resting energy expenditure will be measured at baseline and in the end of the intervention

    20 weeks

Secondary Outcomes (14)

  • Change in fasting Appetite sensations using a Visual Analogue scale after weight loss

    10 weeks

  • Change in fasting Appetite sensations using a Visual Analogue scale after weight loss

    10 weeks

  • Change in post-prandial Appetite sensations using a visual Analogue scale after weight loss

    20 weeks

  • Change in post-prandial Appetite sensations using a visual Analogue scale after weight loss

    20 weeks

  • changes in Food reward using the LFPQ after weight loss

    10 weeks

  • +9 more secondary outcomes

Study Arms (2)

Rapid weight loss

ACTIVE COMPARATOR

Participants in this group will be deprived in 1000 kcal/day (calculated based on their individual energy requirements) for 10 weeks

Behavioral: dieting

Slow weight loss

EXPERIMENTAL

Participants in this group will be deprived in 500 kcal/day (calculated based on their individual energy requirements) for 20 weeks

Behavioral: dieting

Interventions

dietingBEHAVIORAL

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.

Also known as: Caloric restriction (-500 kcal/day), Caloric restriction (-1000 kcal/day)
Rapid weight lossSlow weight loss

Eligibility Criteria

Age20 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Present a 30≥BMI≥40 kg/m2,
  • Present a waist circumference \>88 cm
  • Must be weight-stable (±2 kg last 6 months)
  • Must be sedentary (less than 150 minutes per week)
  • Must be able to read in English
  • Must to present no history of alcohol or drugs abuse
  • Must be pre-menopausal with a regular menstrual cycle

You may not qualify if:

  • present scores \>12 in the 16-item Binge Score Symptoms and/or score \>19 in the Depression Beck Inventory
  • present any history or evidence of cardiovascular disease, peripheral vascular disease, or stroke;
  • be insulin dependent (75g oral glucose tolerance test)
  • present a known renal and/or liver disease
  • present asthma requiring therapy
  • present plasma cholesterol \> 8 mmol/L
  • present systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
  • present previous history of inflammation disease, or cancer,
  • present untreated thyroid or pituitary disease
  • consume regularly medications that could affect cardiovascular function and/or metabolism
  • present food allergies
  • be pregnant
  • be smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hintze LJ, Doucet E, Goldfield GS. The relative reinforcing value of snack food is a significant predictor of fat loss in women with overweight or obesity. Appl Physiol Nutr Metab. 2022 Feb;47(2):134-140. doi: 10.1139/apnm-2021-0382. Epub 2021 Sep 27.

    PMID: 34570984DERIVED

MeSH Terms

Conditions

Weight LossAppetitive BehaviorObesityImpulsive Behavior

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Eric Doucet, PhD

    Universiy of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2018

First Posted

April 30, 2021

Study Start

November 1, 2015

Primary Completion

January 2, 2017

Study Completion

April 30, 2018

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share