Clinical trial NCT04518930: High Fat vs High Protein and Appetite Hormones
Official title: Comparing the Effect of High-Fat (Peanuts) Versus High-Protein (Plain Greek Yogurt) Snacks on Appetite Hormones and Satiety Among Overweight and Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight
Appetitive Behavior
Dietary Exposure
Hormone Deficiency
Keywords: High fat
High protein
Satiety hormones
Appetite
Obesity
Lead sponsor: Al-Balqa Applied University
Sponsor class: OTHER
Collaborators: name: University of Jordan
First posted: 2020-08-19
Enrollment: 52
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Statistical analysis will be performed after data entry using the SPSS statistical software. Prior to analysis data will be tested for normality. Descriptive statistics for continuous (means± SD) and categorical variables (frequencies and percentages) along with analytical statistics including t-test for paired and unpaired means and the repeated measures for the general linear model will be performed too. P \< 0.05 will consider significant.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Appetite hormones
timeFrame: one week
measure: Appetite sensations
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: As-Salţ
country: Jordan
facility: Nahla S Al-Bayyari
state: Al-Balqa
Study officials:
affiliation: Al-Balqa Applied University
name: Nahla S Al-Bayyari, Ph.D
role: STUDY_DIRECTOR
References: