- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07620587
The Role of Estradiol and Progesterone on Appetite Regulation and Energy Balance (E2 & P4 in EB)
Visão geral do estudo
Status
Descrição detalhada
The purpose of this study is to further elucidate the individual and combined effects of estradiol and progesterone on appetite-regulating hormones, perceptions of appetite, energy intake, and energy expenditure over a 13 day supplementation period using a randomized controlled trial (RCT) model in males who will be supplemented with each hormone. Sixty healthy, recreationally active male participants will be randomized into one of four possible groups: placebo (PLA; 400 milligrams (mg) per day glucose polymer), estradiol only (E; 1 mg per day for 2 days & 2 mg per day of estradiol for 11 days + 300 mg Polycose), progesterone only (P; Prometrium, 100 mg per day), or combined estradiol and progesterone (E+P; 1 mg per day for 2 days & 2 mg per day of estradiol for 11 days + 300 mg Polycose for estradiol and 100 mg per day of Prometrium) for a total of ~15 per group. Participants will be provided enough daily dose of each treatment dependent on randomization for a total of 13 days and will be instructed to take each supplement orally at the same time each day for the entirety of the intervention. Participants will report to the lab on the 7th day, where they will be fed a standardized meal and then complete either an acute bout of high-intensity interval training (HIIT; 1 minute on, 1 minute off at 90% HRmax) or a period of seated rest (CTRL). Participants will return on day 12 to complete either the HIIT or CTRL session in an identical manner (whichever was not completed on day 7). Blood samples to measure appetite-regulating hormones and perceptions of appetite will be completed pre-exercise, 0-, 30-, 60-, and 120-minutes post-HIIT and CTRL. While participants are receiving the 13 day treatment, free-living energy intake will be assessed for a 3 day period (day before, day of and day after both in lab visits (HIIT/CTRL; days 6-8 and days 11-13) using the Keenoa® mobile application, and energy expenditure will be measured via thigh-worn accelerometers for the same 3 day periods. An ad libitum meal will also be provided following the HIIT and CTRL sessions.
We anticipate publishing this RCT in two separate manuscripts. Manuscript #1 will focus on the potential effects on the appetite-regulating hormones (acylated ghrelin, GLP-1, CCK) and perceptions of appetite. Manuscript #2 will focus on potential effects on energy balance from the measures of energy intake (including free-living and ad-libitum meal intake) and energy expenditure.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jessica Tucker, MKin, PhD Candidate
- Número de telefone: 4919 519-884-1970
- E-mail: tuck5010@mylaurier.ca
Locais de estudo
-
-
Ontario
-
Waterloo, Ontario, Canadá, N2L 3C5
- Recrutamento
- Energy Metabolism Research Laboratory
-
Contato:
- Jessica Tucker, MKin, PhD Candidate
- Número de telefone: 4919 519-884-1970
- E-mail: tuck5010@mylaurier.ca
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- ages 18-30 years
- deemed healthy using Canadian Society for Exercise Physiology Get Active Questionnaire (CSEP-GAQ)
- non-smoking
Exclusion Criteria:
- failure to meet inclusion criteria
contraindications to exercise as indicated by the (CSEP-GAQ)
- hypersensitivity or allergy to estradiol, progesterone, cellulose, or capsule components
- having been diagnosed with any metabolic disease (ie. diabetes, metabolic syndrome) or current diagnosis of overweight/obesity (BMI > 30.0)
- personal of family history of stroke or thrombotic (blood clot) disease, blood clot disorder, venous or arterial thromboembolic disease, or any possible blood clotting disease
- currently taking anticoagulants, antidiabetic medications, cyclosporine, antihypertensives, and CYP3A4 inducers or inhibitors (e.g., rifampin, ketoconazole, St. John's Wort)
- known liver dysfunction or liver disease
- history of ophthalmic vascular disease
- hormone-dependent malignancies or previous diagnosis of cancer
- recent major surgery (within ~6 months)
- prolonged use of a cast or presence of immobility deeming inability to exercise, diagnosis of inflammatory disorders (ie. rheumatoid arthritis, celiac disease, inflammatory bowel disease)
- history of sensitivity to or extreme nausea/vomiting or any gastrointestinal disorder
- diagnosis of mental health or mood disorder
- presence of abnormal eating behaviours as assessed by the Food Cravings State Questionnaire and the Three Factor Eating Questionnaire
- diagnosed or presence of porphyria or classical migraines
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Placebo Comparator
Participants will be randomized and placed into one of four groups.
The placebo group will receive 400 milligrams (mg) per day of glucose polymer for 13 days total.
The supplementation will be consumed orally at the same time every day for 13 days total.
Participants will not complete more than one arm of the study.
|
See description of intervention arm.
|
|
Experimental: Estradiol Only
Participants will receive 1 mg per day for 2 days and 2 mg per day of estradiol for 11 days + 300 mg polycose.
The supplementation will be consumed orally at the same time every day for 13 days total.
Participants will not complete more than one arm of the study.
|
See description of intervention arm.
|
|
Experimental: Progesterone Only
Participants will receive 100 mg per day of Prometrium (oral progesterone) for 13 days.
The supplementation will be consumed orally at the same time every day for 13 days total.
Participants will not complete more than one arm of the study.
|
See description of intervention arm.
|
|
Experimental: Estradiol and Progesterone Combo
Participants will receive 1 mg per day for 2 days and 2 mg per day estradiolfor 11 days + 300 mg polycose as well as 100 mg per day of Prometrium (oral progesterone).
The supplementation will be consumed orally at the same time every day for 13 days total.
Participants will not complete more than one arm of the study.
|
See description of intervention arm.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Energy balance
Prazo: Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total).
|
Energy balance will be calculated as the difference between energy intake and energy expenditure (see below for description of energy intake and energy expenditure).
|
Energy balance will be measured using the data collected surrounding the exercise and no-exercise sessions (6 days total).
|
|
Acylated Ghrelin
Prazo: To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
|
Appetite-stimulating hormone acylated ghrelin to be measured via commercially available ELISA kits (pg/mL).
|
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
|
|
Glucagon-like Peptide 1 (GLP-1)
Prazo: To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
|
Appetite-inhibiting hormone GLP-1 to be measured via commercially available ELISA kits (pmol/L).
|
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
|
|
Cholecystokinin (CCK)
Prazo: To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
|
Appetite-inhibiting hormone CCK to be measured via commercially available ELISA kits (pg/ml).
|
To be measured pre-exercise, 0 minutes post-exercise, 30 minutes post-exercise, 60 minutes post-exercise, and 120 minutes post-exercise.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Appetite perceptions
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Subjective appetite perceptions will be assessed using visual analogue scales (VAS) validated for four perceptions: hunger (i.e., "How hungry do you feel?"), satisfaction (i.e., "How satisfied do you feel?"), fullness (i.e., "How full do you feel?"), and prospective food consumption (i.e., "How much do you think you can eat?").
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Food Preferences
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
For food preferences, a state food preference questionnaire is a survey or questionnaire used to gather information about individuals' food preferences, and dietary habits.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Ad libitum meal energy intake
Prazo: At the end of each in-lab session (exercise and seated rest; 2 meals total).
|
A post in-lab session meal will be provided to all participants to determine their ad libitum energy intake for this meal by measuring the food provided before the meal as well as the amount of food not consumed using an analog scale .
|
At the end of each in-lab session (exercise and seated rest; 2 meals total).
|
|
Free-living energy intake
Prazo: Day before, day of, and day after each in-lab session (6 days total).
|
Participants will complete a 3 day food record around each in lab session using a mobile application (Keenoa®) monitored by a registered dietician.
|
Day before, day of, and day after each in-lab session (6 days total).
|
|
Energy expenditure
Prazo: Day before, day of, and day after each in-lab session (6 days total).
|
Energy expenditure will be measured for the same 3 days of the food records around both in-lab sessions measured using a thigh-worn accelerometer.
|
Day before, day of, and day after each in-lab session (6 days total).
|
|
Estradiol
Prazo: Pre-exercise only.
|
Sex hormone estradiol measured via radioimmunoassay (pg/mL).
|
Pre-exercise only.
|
|
Progesterone
Prazo: Pre-exercise only.
|
Sex hormone progesterone measured via radioimmunoassay (ng/mL).
|
Pre-exercise only.
|
|
Testosterone
Prazo: Pre-exercise only.
|
Sex hormone testosterone measured via radioimmunoassay.
|
Pre-exercise only.
|
|
Blood glucose
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Will be measured using biochemical assays prior to and following treatment.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Insulin
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Will be measured using biochemical assays prior to and following treatment.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
C-Peptide
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Will be measured using biochemical assays prior to and following treatment.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Peripheral Blood Mononuclear Cells
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured by flow cytometry and biochemical assays/arrays both before and after treatment and before and after an acute bout of exercise.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Inflammatory Cytokines
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured by flow cytometry and biochemical assays/arrays both before and after treatment and before and after an acute bout of exercise.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Brain-derived Neurotrophic Factor (BDNF)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via ELISA kits.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Cathepsin B
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via ELISA kits.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Irisin
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via ELISA kits.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Klotho
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via ELISA kits.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Adrenocorticotropic Hormone
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Dickkopf-1 (DKK-1)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Fibroblast Growth Factor 23 (FGF-23)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Interleukin 1B (IL-1B)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Interleukin-6 (IL-6)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Tumor Necrosis Factor (TNF)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Osteocalcin
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Osteopontin
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Osteoprotegerin (OPG)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Parathyroid Hormone (PTH)
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Sclerostin
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
|
Leptin
Prazo: Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Measured in blood samples via immunoassays.
|
Pre-exercise/seated rest as well as 0 minutes, 30 minutes, 60 minutes and 120 minutes following exercise/seated rest.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tom J Hazell, PhD, Wilfrid Laurier University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EMRL-25-01
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Placebo Comparator
-
University of OxfordHospital General Universitario Gregorio Marañon; Charite University, Berlin,... e outros colaboradoresAinda não está recrutandoPsicose | Psicose Resistente ao TratamentoEspanha, Reino Unido, Alemanha, Israel, Grécia, Itália, Holanda, Suíça
-
Children's Hospital Medical Center, CincinnatiNational Institutes of Health (NIH)Concluído
-
Riphah International UniversityConcluídoParalisia cerebralPaquistão
-
CHIA-HUI MAMackay Memorial HospitalConcluído
-
Ahn-Gook Pharmaceuticals Co.,LtdSamsung Medical Center; Seoul St. Mary's Hospital; Seoul National University Hospital e outros colaboradoresConcluídoRinite alérgica | Rinite Alérgica Perene | Rinite Alérgica Não SazonalRepublica da Coréia
-
Taipei Veterans General Hospital, TaiwanConcluídoQueixa subjetiva de memóriaTaiwan
-
Fondazione Salvatore MaugeriConcluídoDoença de obstrução pulmonar crônicaItália
-
Namik Kemal UniversityInscrevendo-se por conviteEducação paciente | Parto por CesáreaTurquia (Türkiye)
-
Masimo CorporationConcluído
-
Anglia Ruskin UniversityDanone Global Research & Innovation CenterConcluído