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New treatment option for Obesity
Official title Time-Restricted Eating as a Potential Strategy to Promote Weight Loss Maintenance in Patients With Obesity
ClinicalTrials.gov ID: NCT07315659
What this study is testing
- What it's testing
- While body weight reduction can be achieved through various interventions in people living with obesity, most patients regain a substantial proportion of the lost weight within the following months. There is a lack of effective interventions to prevent this regain, making weight regain one of the most pressing challenges in obesity management.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Have a body mass index of 30-45 kg/m2.
- Have safety laboratory test results (general biochemistry and complete blood count) within the normal reference range or with abnormalities...
- Have sufficient venous access for the blood sampling required by the procedures described in this protocol, and not have a phobia of needles or blood.
- Maintain a usual intake window of 11 hours or longer at least 5 days a week and have a response rate greater than 85% during the self-recording...
- Willingness and ability to consume all foods provided during the outcome assessment and dietary intervention.
You likely can't join if
- Having received a diagnosis or presenting signs or symptoms that, in the opinion of the research team, could contraindicate TRE intervention or any...
- Having been diagnosed with or having a history of metabolic (including a diagnosis of any type of diabetes mellitus), hematological, pulmonary...
- Having undergone any surgical procedure that, in the opinion of the research team, could alter energy metabolism or digestive function during the...
- Taking drugs or supplements that are likely to alter body weight or appetite.
- Have experienced weight loss of more than 10% in the last two years, or more than 5% in the last 6 months, unless all the weight lost has been...
- Follow unconventional eating patterns, such as vegan or fasting diets, or be unable to tolerate the foods provided during the study.
See the full eligibility criteria
Who can join
- Have a body mass index of 30-45 kg/m2.
- Have safety laboratory test results (general biochemistry and complete blood count) within the normal reference range or with abnormalities considered clinically insignificant by the medical research team and that do...
- Have sufficient venous access for the blood sampling required by the procedures described in this protocol, and not have a phobia of needles or blood.
- Maintain a usual intake window of 11 hours or longer at least 5 days a week and have a response rate greater than 85% during the self-recording carried out during the screening process.
- Willingness and ability to consume all foods provided during the outcome assessment and dietary intervention.
- Being able to understand and undergo the procedures that are part of the study, in the opinion of the research team.
- Availability to participate in the study.
- Be willing to complete the study regardless of the group to which they are assigned.
What rules you out
- Having received a diagnosis or presenting signs or symptoms that, in the opinion of the research team, could contraindicate TRE intervention or any of the procedures included in the study.
- Having been diagnosed with or having a history of metabolic (including a diagnosis of any type of diabetes mellitus), hematological, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal...
- Having undergone any surgical procedure that, in the opinion of the research team, could alter energy metabolism or digestive function during the course of the study.
- Taking drugs or supplements that are likely to alter body weight or appetite.
- Have experienced weight loss of more than 10% in the last two years, or more than 5% in the last 6 months, unless all the weight lost has been regained.
- Follow unconventional eating patterns, such as vegan or fasting diets, or be unable to tolerate the foods provided during the study.
- Being pregnant or planning to become pregnant within the next two years.
- Being in the postpartum phase (within 12 months of giving birth) or breastfeeding.
- Being in the perimenopausal stage, defined as meeting the criteria of irregular menstrual cycles, hormonal changes indicative of perimenopause, or the presence of menopausal symptoms.
- Participating in a nutritional intervention or treatment or having done so during the previous 3 months.
- Having been diagnosed with or showing signs or risk factors for the development of an eating disorder.
- Experiencing frequent interruptions in the sleep-wake cycle.
- Having clinically significant gastric emptying abnormalities, a current diagnosis of any form of diabetes, blood pressure greater than 160/90 mm Hg, or heart rate below 50 or above 100 beats per minute (sitting), with...
- Have an active or untreated malignant disease or be in remission from a clinically significant malignant disease for less than five years prior to the time of evaluation.
- Having a history of drug or alcohol abuse or testing positive for drugs, unless due to medication prescribed by a healthcare professional.
- Smoking, vaping, or regular use of tobacco products, unless there have been periods of at least 24 consecutive hours without consumption during the last 4 weeks.
- Regular consumption of caffeine in excess of the equivalent of 3 espressos per day (225 mg/day).
- Being a direct relative or cohabitant of research team personnel.
- Any other condition that, in the opinion of the research team, makes participation in the study inadvisable.
The study team makes the final eligibility decision.
Where it's taking place
- Granada, Granada, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Granada, Granada, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.