Impact of a Satiating Diet in Obese Men With a Low Satiety Phenotype

NCT03128697 | Completed

• 1 other identifier: MOP-68858
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

The global research project was organized as a clinical process starting with an evaluation aiming at the determination of a diagnosis pertaining to the degree of satiety signal capacity. It was extended by a phase of metabolic and behavioural characterization to better understand the clinical condition of the patients. The main part of the program was a weight loss intervention that was focused on high satiating foods. Finally, the process was completed by an evaluation allowing to determine the impact of the intervention on the metabolic and behavioural conditions of the patients.

Conditions

Obesity; Appetite Disorders

Keywords

Obesity; Satiety quotient; Appetite control; Weight loss; Satiety phenotype; Functional food

Outcome Measures

Primary Outcomes (2)

• Change from baseline body weight at 16 weeks

  Body weight (kg)

  Pre (Week 0)- and post-intervention (after 16 weeks)

• Change from baseline satiety responsiveness (satiety quotients) at 16 weeks

  Measured by a standardized breakfast test meal using visual analogue scales for 4 appetite sensations (hunger, desire to eat, fullness and prospective food consumption) (mm/100kcal)

  Pre- and post-intervention (week 0 and 16)

Secondary Outcomes (39)

• Change from baseline BMI at 16 weeks

  Pre- and post-intervention (week 0 and 16)

• Change from baseline waist circumference at 16 weeks

  Pre- and post-intervention (week 0 and 16)

• Change from baseline resting blood pressure at 16 weeks

  Pre- and post-intervention (week 0 and 16)

• Change from baseline resting heart rate at 16 weeks

  Pre- and post-intervention (week 0 and 16)

• Change from baseline resting energy expenditure at 16 weeks

  Pre- and post-intervention (week 0 and 16)

Study Arms (4)

Satiating diet-Low satiety phenotype

EXPERIMENTAL

Low satiety phenotype subjects who were submitted to the experimental diet (satiating diet) for a 16-week period.

Behavioral: Satiating diet

Satiating diet-High satiety phenotype

EXPERIMENTAL

High satiety phenotype subjects who were submitted to the experimental diet (satiating diet) for a 16-week period.

Behavioral: Satiating diet

Control diet-Low satiety phenotype

ACTIVE COMPARATOR

Low satiety phenotype subjects who were submitted to the control diet (based on the Canadian Food Guide) for a 16-week period.

Behavioral: Control diet

Control diet-High satiety phenotype

ACTIVE COMPARATOR

High satiety phenotype subjects who were submitted to the control diet (based on the Canadian Food Guide) for a 16-week period.

Behavioral: Control diet

Interventions

Satiating diet BEHAVIORAL

Satiating diet-High satiety phenotype; Satiating diet-Low satiety phenotype

Control diet BEHAVIORAL

Control diet-High satiety phenotype; Control diet-Low satiety phenotype

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged between 30 and 50 years
• obese (BMI between 30 and 40 kg/m2)
• overall good health

You may not qualify if:

• Participants taking medication which could influence appetite sensations (hormones, tranquillizers such as chlorpromazine and benzodiazepin, lithium carbonate for bipolar disorders, cyproheptadine, antihistaminic, serotonin antagonist, sulfonylurea and glucocorticoids)
• Type 2 diabetic patients treated with insulin
• Large body weight fluctuations (\>4 kg over the last two months)
• High level of restraint behaviour (score \> 10 as measured with the Three Factor Eating Questionnaire)
• Performing more than 3 x 30 minutes/week of physical activity.

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Laval University

Québec, G1V 0A6, Canada

Location

Laval Hospital

Québec, G2B 4H4, Canada

Location

Related Publications (3)

• Drapeau V, Blundell J, Gallant AR, Arguin H, Despres JP, Lamarche B, Tremblay A. Behavioural and metabolic characterisation of the low satiety phenotype. Appetite. 2013 Nov;70:67-72. doi: 10.1016/j.appet.2013.05.022. Epub 2013 Jun 20.

  PMID: 23792908 RESULT

• Filiatrault ML, Chaput JP, Drapeau V, Tremblay A. Eating behavior traits and sleep as determinants of weight loss in overweight and obese adults. Nutr Diabetes. 2014 Oct 20;4(10):e140. doi: 10.1038/nutd.2014.37.

  PMID: 25329602 RESULT

• McNeil J, Drapeau V, Gallant AR, Tremblay A, Doucet E, Chaput JP. Short sleep duration is associated with a lower mean satiety quotient in overweight and obese men. Eur J Clin Nutr. 2013 Dec;67(12):1328-30. doi: 10.1038/ejcn.2013.204. Epub 2013 Oct 16.

  PMID: 24129360 RESULT

MeSH Terms

Conditions

Obesity; Feeding and Eating Disorders; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Angelo Tremblay, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

• Drapeau Vicky, PhD

  Laval University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 25, 2017
• Study Start: October 1, 2004
• Primary Completion: September 30, 2008
• Study Completion: September 30, 2008
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)