Weight LossNCT05141526
Satiating Diet, Appetite Control and Body Weight Loss in Individuals With Obesity
A study testing Non-restrictive satiating intervention and Conventional restrictive intervention + non-restrictive satiating intervention in people with Weight Loss and Weight Maintenance, run by Laval University at 1 site in Canada.
Trial summary
The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Weight Maintenance, Appetite Control
- What is being tested?
- Non-restrictive satiating intervention and Conventional restrictive intervention + non-restrictive satiating intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2022to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals with a BMI ≥30 and <40 kg/m2
- aged between 18-50 years
- waist circumference >102 cm in men and >88 cm in women.
Who cannot join
- taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids)
- being treated with insulin for type 2 diabetes
- large body weight fluctuations (>4 kg over last two months)
- characterized by high restraint behaviour (score >12, measured with the TFEQ)
- history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire
- performing >150 min of moderate-vigorous intensity physical activity/week
Show all 14Show fewer
- use of nutritional supplements (multivitamins, calcium, protein, fibre); 8) smoking, drugs or alcohol (>2 drinks/d)
- consumption of >5 cups of coffee/d
- (pre)menopausal or pregnant women
- diagnosis of chronic diseases, acute infections or gastric problems (e.g. ulcers)
- food allergies/intolerances to ingredients/foods in the satiating intervention
- having a pacemaker (for fMRI)
- taking sedatives or sleeping pills
- symptoms of depression (>20 on the BDI).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Department of Physical Education
Québec, Quebec, G1V0A6
Lucie Brunelle, Msc, RD
About this study
Official title: Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?
The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss [Phase 1 (P1): 6 months] and maintenance trial [Phase 2 (P2): 12 months] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.
- Conditions
- Weight Loss, Weight Maintenance, Appetite Control
- Being tested
- Non-restrictive satiating intervention, Conventional restrictive intervention + non-restrictive satiating intervention, Control group
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-restrictive satiating interventionOther
Diet group containing satiating foods
Conventional restrictive intervention + non-restrictive satiating interventionOther
Diet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase
Control groupOther
This group will receive minimal healthy guidelines
| Study group | Role | What they receive |
|---|---|---|
| Non-restrictive satiating intervention | Experimental | The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Receives: Other: Non-restrictive satiating intervention |
| Conventional restrictive intervention + non-restrictive satiating intervention | Experimental | Conventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2) Receives: Other: Conventional restrictive intervention + non-restrictive satiating intervention |
| Minimal healthy guidelines | Placebo comparator | Considering recommendations from the latest Canadian Obesity Guidelines, the control group will receive a minimal intervention based on the Canada's Food Guide for Healthy Eating Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight loss (kg) after Phases 1 and 2
Measured: 6 months
Body composition
Body fat (using dual x-ray absorptiometry)
Measured: 6 months
Hunger/Satiety
using a visual analogue scale and measured in mm
Measured: 6 months
Energy intake
measured at an ad libitum meal in kilocalories
Measured: 6 months
Secondary outcomes (8)
Stress
State-Trait Anxiety Inventory
Measured: 18 months
Anxiety
Perceived Stress Scales
Measured: 18 months
Eating Behaviours
Three Factor Eating Behaviour Questionnaire
Measured: 18 months
Depression Symptoms
Beck Depression Inventory
Measured: 18 months
Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)
measured in mmol/L
Measured: 18 months
Blood pressure
mmHg
Measured: 18 months
Diet satisfaction
Diet Satisfaction Questionnaire (scale: strongly disagree to strongly agree)
Measured: 18 months
neurobehavioural variables
brain anatomy and activity in response to food cues (using fMRI)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Jan 2022
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). \*P1=phase 1; P2=phase 2
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Principal investigator, Vicky Drapeau, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141526
- Sponsor's protocol ID
- SAT-2-129796
- Status last verified
- Oct 2023
- First submitted
- 20 Sep 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-restrictive Approach to Facilitate Appetite Control and Long-term Body Weight Loss in Individuals With Obesity: Can we do Better?
- ClinicalTrials.gov ID
- NCT05141526
- Acronym / sponsor ID
- SAT-2-129796
- Conditions
- Weight Loss, Weight Maintenance, Appetite Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate (1) the effect of a non-restrictive satiating intervention on appetite control, body weight loss and maintenance; and (2) determine whether switching to a non-restrictive satiating intervention following a conventional restrictive intervention can prevent increases in appetite and attenuate body weight regain usually observed after weight loss in men and women living with obesity. This is an 18-month, randomized, controlled, parallel weight loss [Phase 1 (P1): 6 months] and maintenance trial [Phase 2 (P2): 12 months] with three groups (n=234 men and women): (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). All groups will be controlled for physical activity and sleep patterns. The non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). Measurements at baseline (week 0), after P1 and P2 will include the following primary outcomes: appetite control, weight loss and maintenance; and secondary outcomes: body composition, physiological, psycho and neurobehavioural and health-related variables. Follow-ups will be done by a dietitian every 2 weeks during P1 and once a month during P2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- (1) non-restrictive, satiating intervention (P1) followed by a continuation of this intervention (P2); (2) conventional restrictive intervention (-500 kcal/d) (P1) followed by a non-restrictive satiating intervention (P2); (3) control group that follows minimal healthy guidelines (P1) followed by recommended weight maintenance strategies (P2). *P1=phase 1; P2=phase 2
| Arm | Type | Receives |
|---|---|---|
| Non-restrictive satiating intervention | Experimental | Other: Non-restrictive satiating interventionThe non-restrictive satiating intervention will include guidelines and recipes to prepare highly satiating meals that will be low in energy density and glycemic index and high in protein, polyunsaturated fats, vitamins and minerals (e.g. calcium), and certain constituents of spices (e.g. capsaicin). |
| Conventional restrictive intervention + non-restrictive satiating intervention | Experimental | Other: Conventional restrictive intervention + non-restrictive satiating interventionConventional restrictive intervention consisting of a -500 kcal/d calorie deficit (P1) followed by a non-restrictive satiating intervention (P2) |
| Minimal healthy guidelines | Placebo comparator | Other: Control groupConsidering recommendations from the latest Canadian Obesity Guidelines, the control group will receive a minimal intervention based on the Canada's Food Guide for Healthy Eating |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- individuals with a BMI ≥30 and <40 kg/m2
- aged between 18-50 years
- waist circumference >102 cm in men and >88 cm in women.
Key exclusion criteria (14 listed)
- taking medications that could influence appetite or body weight (e.g. thyroid replacement therapy, sulfonylureas and glucocorticoids)
- being treated with insulin for type 2 diabetes
- large body weight fluctuations (>4 kg over last two months)
- characterized by high restraint behaviour (score >12, measured with the TFEQ)
- history of an eating disorder (e.g. binge eating disorder) using the EDE questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-restrictive satiating interventionDiet group containing satiating foods | Other | Non-restrictive satiating intervention |
| Conventional restrictive intervention + non-restrictive satiating interventionDiet group with a calorie deficit during the first phase followed by a diet containing satiating foods in the second phase | Other | Conventional restrictive intervention + non-restrictive satiating intervention |
| Control groupThis group will receive minimal healthy guidelines | Other | Minimal healthy guidelines |
Primary outcome
Body weight
Time frame: 6 months
Body weight loss (kg) after Phases 1 and 2
Body composition
Time frame: 6 months
Body fat (using dual x-ray absorptiometry)
Hunger/Satiety
Time frame: 6 months
using a visual analogue scale and measured in mm
Energy intake
Time frame: 6 months
measured at an ad libitum meal in kilocalories
8 secondary outcomes
Stress
Time frame: 18 months
Anxiety
Time frame: 18 months
Eating Behaviours
Time frame: 18 months
Depression Symptoms
Time frame: 18 months
Lipids (HDL-cholesterol, LDL-cholesterol, triglycerides, total cholesterol)
Time frame: 18 months
Blood pressure
Time frame: 18 months
Diet satisfaction
Time frame: 18 months
neurobehavioural variables
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
Related trials for Weight Loss
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-restrictive satiating intervention and Conventional restrictive intervention + non-restrictive satiating intervention in people with Weight Loss and Weight Maintenance, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vicky Drapeau, PhD (4186562131, vicky.drapeau@fse.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.