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临床试验/NCT04518930
NCT04518930已完成不适用

Comparing the Effect of High-Fat (Peanuts) Versus High-Protein (Plain Greek Yogurt) Snacks on Appetite Hormones and Satiety Among Overweight and Obese Women

Al-Balqa Applied University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
Appetite hormones

研究概览

简要总结

This study will investigate the effects of high-protein, high-fat snacks, specifically Greek yogurt, and peanuts, on satiety, gut hormones, and insulin secretion in overweight and obese women. The hypothesis posited that peanuts will exhibit a more beneficial impact on satiety, gut hormones, and insulin levels compared to Greek yogurt. The two-arm parallel randomized trial will involve 52 participants aged 30 to 40 with a BMI between 25-35 kg/m²,and they will be randomly divided into peanut (n=26) and Greek yogurt (n=26) groups. Pre-snack, BMI and dietary intake will be assessed. Appetite sensations will be gauged using a visual analog scale (VAS) upon arrival, and at 30- and 60-minutes post-snack. Pre- and post-snacking, plasma levels of cholecystokinin (CCK), Peptide Tyrosine-Tyrosine (PYY), Glucagon Like Peptide-1 (GLP-1), Ghrelin (GHRL), and insulin will be analyzed.

详细描述

The study's inclusion criteria will be encompassed women aged between 30 and 40 years, with a body mass index (BMI) ranging from 25 to 35 kg/m². These individuals engaged in light exercise 1-3 times per week (activity factor 1.375) and adhered to a routine of consuming three regular meals, along with two daily snacks, and maintaining a water intake of eight cups and do not have allergies to nuts or yogurt.

All participants should adhere to a 1200 kcal diet plan, which included breakfast, snack 1, lunch, snack 2, and dinner. This diet plan will remain consistent for all participants over a consecutive three-day period, except for the snacks that will be provided during the second visit. The specific snack assigned to each participant will be determined based on a predetermined randomization list. The first experimental group (n=26) will receive a high-protein snack in the form of plain Greek yogurt, while the second experimental group (n=26) will receive a high-fat snack in the form of peanuts.

Prior to intervention, in the first visit all anthropometric and body composition assessments will be performed. On the second visit which will be scheduled after three days of adhering to the 1200 Kcal diet, all participants should arrive at the clinic at 1:00 pm and they should had their breakfast at home at 9:00 am. Upon arrival, a baseline blood samples from each participant will be collected.

At 1:00 pm, participants in the plain Greek yogurt and peanut groups will consume their assigned snacks. Following snack consumption, a validated visual analog scale (VAS) questionnaire will be distributed to assess sensations and appetite levels at 0 minutes (1:00 pm), 30 minutes (1:30 pm), and 60 minutes (2:00 pm).

One hour after their arrival, at 2:00 pm, a second blood sample will be collected from all participants. Serum samples will be used to analyze the Ghrelin, PYY, CCK, Glp-1 and insulin using human ELISA kits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged between 30 and 40 years, with a body mass index (BMI) ranging from 25 to 35 kg/m², engaged in light exercise 1-3 times per week (activity factor 1.375) and adhered to a routine of consuming three regular meals, along with two daily snacks, and maintaining a water intake of eight cups and do not have any allergies, particularly to peanuts, and yogurt.

排除标准

  • Women aged below 30 years or above 40 years, BMI below 25 kg/m² or above 35 kg/m², engaged in little or no exercise or engaged in moderate to heavy exercise, pregnant or lactating mothers, had allergies to nuts, peanuts, yogurt, milk, or milk products, using medications, hormonal therapy, supplements, oral contraceptives, or herbal/botanical products claimed to suppress appetite. Women in menopausal state, in their menstrual cycle days, or within one week before their menstrual cycle days will be excluded. Those with chronic diseases such as cardiovascular diseases, diabetes, hypertension, kidney diseases, thyroid disorders, gastrointestinal diseases, polycystic ovary syndrome, or androgen disorders, following a weight-reducing diet, experiencing sleep disorders, or sleeping less than 8 hours per day, and consuming less than 8 cups of water per day will also excluded.

研究组 & 干预措施

high fat

Experimental

26 participants will be provided with (35) g of roasted, not salted peanuts as snack.

干预措施: Peanuts or plain Greek yogurt (Other)

high protein

Experimental

26 participants will be provided with (380) g of Plain Greek yogurt after as snack.

干预措施: Peanuts or plain Greek yogurt (Other)

结局指标

主要结局

Appetite hormones

时间窗: one week

The effects of peanut snacking versus plain Greek yogurt on appetite hormones will be measured on Cholecystokinin, Ghrelin, Peptide YY, and Glucagon Like Peptide-1 and Insulin levels

Appetite sensations

时间窗: 8 weeks

The effect of peanut snacking versus plain Greek yogurt on appetite sensations will be measured using validated visual analog scale (VAS) questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nahla Bayyari

Clinical professor

Al-Balqa Applied University

研究点 (2)

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