A Double-blind, Cross-over, Placebo-controlled, Proof-of-concept Study Using Oral Peptide YY3-36 Solution to Investigate the Mechanistic Role of Lingual PYY in Regulating Appetite, Energy Intake and Food Preference in People With Overweight/Obesity
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- appetite scores
研究概览
简要总结
A double-blind, cross-over, placebo-controlled, proof-of-concept study using oral peptide YY3-36 solution to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity. The aim of this study is to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity.
详细描述
In order to address the study objective two independent investigations in two separate groups of participants will need to be undertaken, to avoid cross-contamination of the results.
- Cohort/Investigation 1: A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating fasted and post-meal appetite following a fixed energy intake meal.
- Cohort/Investigation 2: A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating ad libitum energy intake and food preference.
People with overweight or obesity (BMI 25.0-39.9 kg/m2), identified via the University College London Hospitals (UCLH) Bariatric Centre for Weight Management and Metabolic Surgery and through advertising via University College London (UCL) and ULCH, will be invited to take part.
Potential participants will initially attend a screening visit, where informed, written consent will first be taken. During the screening visit, medical, drug and dietary histories will be taken and participant eligibility will be confirmed.
Participants will attend on two separate occasions at least 7 days apart for both cohort/investigation 1 and cohort/investigation 2. 20 participants per cohort/investigation will be randomised (in a 1:1 manner), stratified by sex, to receive either oral PYY3-36 solution or matched placebo at their first study visit. Participants will be recruited onto study/investigation 1 first and once this is complete, new subjects will be enrolled onto study/investigation 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 inclusive.
- •People with a body mass index (BMI) between 25.0 and 39.9 kg/m2
- •Stable weight for past 3 months (≤5% change in preceding 3 months as reported by participants).
- •Females of childbearing potential must be on highly effective contraception and have a negative pregnancy test within 7 days of their study visits. NOTE: Subjects are considered not of childbearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Fluent in English and able to understand and complete questionnaires.
- •Willing and able to provide written informed consent and comply with the study protocol.
排除标准
- •Female subjects who are pregnant or breast-feeding.
- •Female subjects of childbearing potential who are not on highly effective contraception.
- •Post-menopausal women who have not had a period of spontaneous amenorrhea for more than 1 year.
- •Previous bariatric surgery.
- •Type 1 or 2 diabetes.
- •Current use of weight loss medications or taking medication that affects appetite, e.g., antidepressants such as mirtazapine.
- •Food intolerances, or allergies, that would make fixed energy meal and/or ad libitum meal unable to be performed.
- •Impairment of sense of taste and/or smell, as per subject assessment and direct questioning.
- •Poor dental hygiene or oral pathology.
- •Current smokers of tobacco products.
- •Any other factor making the participant unsuitable in the view of investigator.
研究组 & 干预措施
Cohort/Intervention 1
Meal test
干预措施: PYY (3-36) Peptide (Drug)
Cohort/Intervention 1
Meal test
干预措施: Placibo (Drug)
Cohort/Intervention 2
Ad libitum meal
干预措施: PYY (3-36) Peptide (Drug)
Cohort/Intervention 2
Ad libitum meal
干预措施: Placibo (Drug)
结局指标
主要结局
appetite scores
时间窗: up to 6 hours
area-under-the curve for appetite scores. Not indicative of either bad or worse outcome, just subjective indication.
energy intake expressed as Kcal of eaten food
时间窗: up to 6 hours
ad libitum energy intake
次要结局
- 24h appetite(24 hours after study visit)
- gut hormones levels(up to 6 hours)
- 24-h energy intake(24 hours after study visit)
- macronutrient selection(up to 1 hour)
- PYY levels(up to 6 hours)
- food preference using labelled magnitude scales (LMS)(through study completion, an average of 6 hours)
- food preference questionnaire (FPQ)(once, at beginning of study visit)