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Weight Loss and Hunger

27 lipca 2026 zaktualizowane przez: Eric Doucet, University of Ottawa

Weight Loss and Hunger: Did we Get it Wrong All This Time?

Weight loss is difficult and weight maintenance even worse. The principles of dieting dictate that to maintain weight loss, one has to eat less calories than they did before the diet. However, there is evidence to show that it may be the diet per se and not the weight loss that makes people more hungry and vulnerable to weight regain. This study will explore whether appetite control can be restored to normal levels through an individually tailored increase in calories after weight loss. If supported, the findings from this study could alter the way we view dieting.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

Weight loss reduces all components of the energy budget, i.e. resting energy expenditure (EE), the thermic effect of feeding and the energy cost of physical activities. The corollary of this observation is that to achieve energy balance at a lowered body weight (if EE is not increased through purposeful physical activity), energy intake (EI) needs to be kept at this lowered level of EE. While the math of the equation is simple, the operationalization has proven to be quite different. In fact, a dominant feature of weight loss is that it produces increases in hunger that appear within the first days, persist into weight loss and for at least a year after the intervention. As such, identifying strategies that abate changes in hunger and facilitate post-weight loss appetite control should be viewed as a central tenant of obesity interventions. However, data points to the possibility that it may well be the reduction in EI needed to produce weight loss that actually increases hunger. If this were to be the case, then forcing lower EI after weight loss likely exacerbates the state of increased hunger, paving the way for weight rebound. If there is somewhat a set value of EI for each individual, then current dietary strategies aimed at tailoring a food landscape conducive of reduced hunger with reduced EI needed to sustain weight loss, are destined to fail.

Primary hypotheses- The increase of EI to pre-weight loss values will significantly attenuate weight loss induced increases in hunger.

Secondary hypothesis- The increase of EI to pre-weight loss values will significantly attenuate weight loss induced metabolic adaptations (Greater than Predicted decreased in EE).

The increase of EI to pre-weight loss will significantly improve post weight loss ghrelin, PYY and GLP-1 responses.

Research plan- Fifty individuals living with obesity (25 men and 25 women BMI ≥ 30 kg/m2) will undergo a 20-week weight-loss intervention. After weight loss they will be randomly assigned to a 1-month experimental condition comprising of either : 1) a weight maintenance diet; or to 2) an increase of EI to pre-weight loss levels combined with increased exercise to maintain energy balance. A detailed investigation of energy balance variables will be conducted at all three time points.

Relevance- Discovery drives paradigm changes, which hold the promise of catalyzing innovation in treatment. The clinical impact of a setpoint EI is that it would inform more tailored personalized dietary intervention based on one's individual pre-weight loss EI rather than post-weight loss outcomes, which is the current standard of care for maintenance of weight loss. In other words, it could inform the precise corrections in EE (from physical activity) needed to not exacerbate appetite control, and to likely favour healthier weights.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1S 5S9
        • University of Ottawa
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Eric Doucet, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. 18-55 years of age;
  2. non-smoking;
  3. obese class I-II (30 kg/m2 ≤ BMI < 40 kg/m2);
  4. weight stable (± 2 kg during the 6 months prior to enrollment);
  5. Sedentary (<2 times/week of 30 min of continuous exercise)

In addition, Females will be included if:

1) premenopausal (2 menses in the 3 months preceding testing, no increase in cycle irregularity in the 12 months preceding testing).

Exclusion Criteria:

  1. have a current diagnosis of an axis 1 psychiatric disorder (i.e. mood, anxiety and eating disorders);
  2. currently use antidepressants, thyroid medication, or any medication that could affect appetite;
  3. have a history of cardiac problems or symptoms suggestive of any cardiac condition;
  4. have a current diagnosis or history of diabetes, confirmed by a measure of HbA1c during the screening visit;
  5. have alcohol intake that exceeds recommendations or alcoholism, or current addictions to opiates, cocaine or stimulants;
  6. currently taking monoamine oxidase inhibitors, pressor agents, warfarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants;
  7. have uncontrolled thyroid disease;
  8. have any osteoarticular condition, or other reasons that would prevent them from achieving the proposed walking targets.

In addition, Females will be excluded if they:

  1. are pregnant or planning to become pregnant over the course of the study;
  2. are peri- or post-menopausal or have had surgically induced menopause.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: High Energy Flux
After weight loss through a dietary intervention, the high flux group will remain in a state of energy balance through an increase in exercise and an increase in energy intake to pre-weight loss values.
Behawioralne: Exercise
Daily kilometer target at normal walking pace (~5km/h). The American College of Sports Medicine (ACSM) metabolic equation for the caloric cost of walking will be used to assess the distance needed to be covered daily.
Behawioralne: Dietary Intervention

Participants will be prescribed a 20-week energy-restricted diet (-25% of energy requirements). A registered dietitian will be responsible for nutrition counselling and will use the Canadian Diabetes Association's Exchange System to prescribe the diet plan. During the weight loss phase, participants will receive a revised diet plan, based on the adjusted energy requirements that will account for the achieved weight loss.

After weight loss, the diet plan will be revised based on the group (high-energy flux vs low-energy flux) to be in a state of energy balance.
Komparator placebo: Low Energy Flux
After weight loss through a dietary intervention, the low-energy flux group will remain in energy balance but at a lower energy flux, with no changes in exercise levels and energy intake remaining lower than pre-weight-loss values.
Behawioralne: Dietary Intervention

Participants will be prescribed a 20-week energy-restricted diet (-25% of energy requirements). A registered dietitian will be responsible for nutrition counselling and will use the Canadian Diabetes Association's Exchange System to prescribe the diet plan. During the weight loss phase, participants will receive a revised diet plan, based on the adjusted energy requirements that will account for the achieved weight loss.

After weight loss, the diet plan will be revised based on the group (high-energy flux vs low-energy flux) to be in a state of energy balance.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Appetite measurements
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).

Desire to eat, hunger, fullness, and prospective food consumption (PFC) will be rated immediately before (after a 12 h overnight fast) and every 30 min*3 h after the standardized breakfast on a 100-mm visual analog scale (VAS) adapted from Hill and Blundell. Scores range from 0 to 100 millimeters. For hunger, desire to eat, and prospective food consumption, higher scores indicate greater appetite. For fullness, higher scores indicate greater fullness (lower appetite).

The satiety quotient will be calculated for each subject.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Plasma concentrations of appetite-regulating hormones
Ramy czasowe: Blood samples will be collected at each experimental session: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), and onset of week 25 (after the 1-month weight-maintenance period).
Blood samples will be collected during experimental sessions while fasting and every 30 minutes for 3 hours following the standardized breakfast. EDTA and Aprotinin (anti-protease) and DPP-IV inhibitors will be added to whole-blood before it is centrifuged at 3000 rpm for 5 minutes at 4˚C. Plasma will be treated within an hour of sampling and then stored at -80˚C until assayed. Total Ghrelin (EZGRT-89K), Leptin (EZHL-80SK), GLP-1 (EZGLP1T-36K) and PYY (EZHPYYT66K) will be assayed with commercially available ELISA (Millipore). All samples from one subject will be assayed in duplicates in the same plate to avoid inter-assay variability.
Blood samples will be collected at each experimental session: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), and onset of week 25 (after the 1-month weight-maintenance period).
Resting Energy Expenditure
Ramy czasowe: Resting Energy Expenditure will be measured during the screening session (2 weeks before baseline), at baseline, end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
The ventilated hood technique and the Vmax Encore 29 N metabolic cart (SensorMedics Corporation) will be used to perform indirect calorimetry. Carts are calibrated with reference gases each day. Measures will occur between 7:00 and 9:30 am after a 12-h fasting period, while also abstaining from exercise for at least 24 h, always performed in the same room, kept dark and at an ambient temperature of 21° C. Indirect calorimetry will be performed for 30 minutes.
Resting Energy Expenditure will be measured during the screening session (2 weeks before baseline), at baseline, end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Exercise Energy Expenditure
Ramy czasowe: Accelerometer: worn for 7 days at each sampling period (screening, week 20 (end of weight loss intervention), weeks 22 and 24 (middle and end of weight maintenance). Exercise energy expenditure will be measured once per week during weight maintenance.

Free-living exercise energy expenditure will be measured using accelerometry. An accelerometer (Actical-Mini Mitter Co. Inc.) will be worn on the lower back for 7 days at each sampling period.

Exercise energy expenditure will also be measured with a COSMED K4b2 portable indirect calorimeter during in-laboratory exercise sessions completed on the treadmill to confirm the accuracy of exercise energy expenditure.
Accelerometer: worn for 7 days at each sampling period (screening, week 20 (end of weight loss intervention), weeks 22 and 24 (middle and end of weight maintenance). Exercise energy expenditure will be measured once per week during weight maintenance.
Total Energy Expenditure
Ramy czasowe: The DLW dose will be consumed during the screening session, and participants will provide their first urine sample. A second sample will be collected on the following day, and a 3rd 7 days later.
Total EE will be determined from doubly-labelled water (DLW) over a 7-day period to estimate carbon dioxide production over time in free-living subjects. After deuterated water is administered, 2H is lost from the body water at an exponential rate. When 18O-water is administered, the 18O is also lost with body water turnover (as per the 2H isotope) and with each molecule of carbon dioxide produced because carbonic anhydrase in the body rapidly facilitates the equilibrium exchange of water and carbon dioxide/carbonic acid oxygen. The difference between the rates of disappearance of 2H and 18O corresponds to the total carbon dioxide production over that period. These rates are determined from urine samples taken at the start and at the end of the measurement period. DLW is the gold standard for assessing free-living EE.
The DLW dose will be consumed during the screening session, and participants will provide their first urine sample. A second sample will be collected on the following day, and a 3rd 7 days later.
Energy Intake
Ramy czasowe: In-lab energy intake: Baseline, end of week 20 (after the weight-loss intervention), and at the onset of week 25 (after one month of weight maintenance). Free-living energy intake will be measured for 3 days after the screening session.
EI will be measured in the laboratory and in the free-living state for 3 days with a food menu that we have developed and validated. In the laboratory, foods are served upon request, while outside the laboratory, foods are selected and packed away into coolers, somewhat like grocery shopping, and leftovers are brought back with wrappings to assess the weight of foods consumed. Food Processor SQL (ESHA Research Inc.) will be used.
In-lab energy intake: Baseline, end of week 20 (after the weight-loss intervention), and at the onset of week 25 (after one month of weight maintenance). Free-living energy intake will be measured for 3 days after the screening session.
Food Reward
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period). The test lasts approximately 10 minutes.
The Leeds Food Preference Questionnaire, a forced-choice computer task, will be used to evaluate the implicit hedonic wanting (speed and frequency of choice) and the explicit hedonic liking (subjective visual analog scale rating) for different visual food cues, which vary in both fat and sugar content. The task assesses explicit liking and explicit wanting for food stimuli. Scores range from 0 to 100, with higher scores indicating greater liking or wanting for the presented foods. The Leeds Food Preference Questionnaire will be administered both before and after lunch.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period). The test lasts approximately 10 minutes.
Olfactory and Taste Performance
Ramy czasowe: Olfactory and taste performance will be assessed during the in-laboratory at baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Nasal chemosensory and taste performance will be measured with Sniffin' Sticks and taste strips (Burghart Instruments, Wedel, Germany).
Olfactory and taste performance will be assessed during the in-laboratory at baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Body weight
Ramy czasowe: Baseline, weeks: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 21, 22, 23, 24, 25.
Body weight (kg) will be measured with a digital scale (BWB-800AS Digital Scale from Tanita Corporation of America).
Baseline, weeks: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 21, 22, 23, 24, 25.
Height
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Height (centimeter) will be measured using a stadiometer (HR-100 Height Rod).
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Fat-mass
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Total body fat mass and percentage of total body fat will be assessed using dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy, GE Medical Systems). Total body fat mass is reported in kilograms (kg), and percentage of total body fat is reported as a percentage (%) of total body weight. Higher values for both measures indicate greater total body fat.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Fat-free mass
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Total body fat-free mass will be assessed using dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy, GE Medical Systems). Fat-free mass is reported in kilograms (kg) and represents the mass of all non-fat tissues, including muscle, organs, and bone. Higher values indicate greater fat-free mass.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Bone mineral content
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Total body bone mineral content will be assessed using dual-energy X-ray absorptiometry (DXA) (Lunar Prodigy, GE Medical Systems). Bone mineral content is reported in grams (g). Higher values indicate greater total body bone mineral content.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Thermic effect of Food
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
A standardized breakfast consisting of 2 slices of whole wheat bread (80 g), peanut butter (20 g), strawberry jam (20 g), cheddar cheese 27% milk fat (20 g), and orange juice (250 mL). The total energy content is 575 kcal, and its food quotient will be 0.89 (57% carbohydrates, 13% protein, 30% lipids) for the 3 experimental sessions. Comparable alternatives will be offered in cases of food aversions, intolerances, or allergies. After breakfast, resting energy expenditure will be measured for 30 minutes every hour for a total of 3h. The same protocol described in the "resting energy expenditure section" will be used to assess the thermic effect of food (increase in energy expenditure above fasting values for the digestion, absorption, biosynthesis, and storage of nutrients).
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Eating behaviour assessed using the Three-Factor Eating Questionnaire-51
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Eating behaviour will be assessed using the Three-Factor Eating Questionnaire-51 (TFEQ-51). The questionnaire assesses three domains of eating behaviour: dietary restraint, disinhibition, and perceived hunger. Scores are calculated according to published scoring procedures. Dietary restraint scores range from 0 to 21, disinhibition scores range from 0 to 16, and hunger scores range from 0 to 14. Higher scores indicate greater cognitive restraint, greater disinhibition, and greater susceptibility to hunger, respectively.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Health-related quality of life assessed using the 36-Item Short Form Health Survey
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The SF-36 evaluates eight health domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. Each domain is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Mood assessed using the Positive and Negative Affect Schedule
Ramy czasowe: Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).
Mood will be assessed using the Positive and Negative Affect Schedule (PANAS). The questionnaire includes two subscales assessing positive affect and negative affect. Each subscale consists of 10 items scored from 1 to 5, resulting in total scores ranging from 10 to 50 for each subscale. Higher positive affect scores indicate greater positive affect, whereas higher negative affect scores indicate greater negative affect.
Baseline (1 week before the dietary intervention), end of week 20 (after the weight-loss intervention), onset of week 25 (after the 1-month weight-maintenance period).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Ottawa

Współpracownicy

Canadian Institutes of Health Research (CIHR)

Śledczy

  • Główny śledczy: Eric Doucet, PhD, University of Ottawa

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2028

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

14 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 lipca 2026

Pierwszy wysłany (Rzeczywisty)

31 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

31 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

27 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • H-10-25-12071
  • 541343 (Inny numer grantu/finansowania: Canadian Institutes of Health Research)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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