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Weight Loss and Hunger

No phase Interventional Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise, Dietary Intervention.
Who it may be relevant to
Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.
  • Behavioral 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-

Primary outcome measures

  • Appetite measurements [Time frame: 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).]
Secondary outcome measures (12)
  • Plasma concentrations of appetite-regulating hormones [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, weeks: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 21, 22, 23, 24, 25.]
  • Height [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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).]

Eligibility criteria

Inclusion criteria

  • 18-55 years of age;
  • non-smoking;
  • obese class I-II (30 kg/m2 ≤ BMI < 40 kg/m2);
  • weight stable (± 2 kg during the 6 months prior to enrollment);
  • 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

  • have a current diagnosis of an axis 1 psychiatric disorder (i.e. mood, anxiety and eating disorders);
  • currently use antidepressants, thyroid medication, or any medication that could affect appetite;
  • have a history of cardiac problems or symptoms suggestive of any cardiac condition;
  • have a current diagnosis or history of diabetes, confirmed by a measure of HbA1c during the screening visit;
  • have alcohol intake that exceeds recommendations or alcoholism, or current addictions to opiates, cocaine or stimulants;
  • currently taking monoamine oxidase inhibitors, pressor agents, warfarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants;
  • have uncontrolled thyroid disease;
  • 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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • University of Ottawa — Ottawa

Publications

  • Machado AM, Guimaraes NS, Bocardi VB, da Silva TPR, Carmo ASD, Menezes MC, Duarte CK. Understanding weight regain after a nutritional weight loss intervention: Systematic review and meta-analysis. Clin Nutr ESPEN. 2022 Jun;49:138-153. doi: 10.1016/j.clnesp.2022.03.020. Epub 2022 Mar 31. PMID 35623805
  • Doucet E, McInis K, Mahmoodianfard S. Compensation in response to energy deficits induced by exercise or diet. Obes Rev. 2018 Dec;19 Suppl 1:36-46. doi: 10.1111/obr.12783. PMID 30511511
  • Cameron JD, Goldfield GS, Riou ME, Finlayson GS, Blundell JE, Doucet E. Energy depletion by diet or aerobic exercise alone: impact of energy deficit modality on appetite parameters. Am J Clin Nutr. 2016 Apr;103(4):1008-16. doi: 10.3945/ajcn.115.115584. Epub 2016 Feb 17. PMID 26888712
  • Leibel RL, Rosenbaum M, Hirsch J. Changes in energy expenditure resulting from altered body weight. N Engl J Med. 1995 Mar 9;332(10):621-8. doi: 10.1056/NEJM199503093321001. PMID 7632212
  • Schwartz A, Doucet E. Relative changes in resting energy expenditure during weight loss: a systematic review. Obes Rev. 2010 Jul;11(7):531-47. doi: 10.1111/j.1467-789X.2009.00654.x. Epub 2009 Sep 17. PMID 19761507
  • Dulloo AG, Jacquet J, Girardier L. Poststarvation hyperphagia and body fat overshooting in humans: a role for feedback signals from lean and fat tissues. Am J Clin Nutr. 1997 Mar;65(3):717-23. doi: 10.1093/ajcn/65.3.717. PMID 9062520
  • Anderson JW, Konz EC, Frederich RC, Wood CL. Long-term weight-loss maintenance: a meta-analysis of US studies. Am J Clin Nutr. 2001 Nov;74(5):579-84. doi: 10.1093/ajcn/74.5.579. PMID 11684524
  • Ryan DH. Risks and benefits of weight loss: challenges to obesity research. European Heart Journal 2005; (7): L27-L31.

Identifiers

NCT: NCT07739095 · H-10-25-12071 · 541343

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗