High Fat vs High Protein and Appetite Hormones

NCT ID: NCT04518930

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-10-22

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.

Conditions

Body Weight; Appetitive Behavior; Dietary Exposure; Hormone Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

high fat

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

Group Type: EXPERIMENTAL

Peanuts or plain Greek yogurt

Intervention Type: OTHER

Two different types of dietary snacks

high protein

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

Group Type: EXPERIMENTAL

Peanuts or plain Greek yogurt

Intervention Type: OTHER

Two different types of dietary snacks

Interventions

Peanuts or plain Greek yogurt

Two different types of dietary snacks

Intervention Type: OTHER

Other Intervention Names

snack

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jordan

OTHER

Sponsor Role: collaborator

Al-Balqa Applied University

OTHER

Sponsor Role: lead

Responsible Party

Nahla Bayyari

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nahla S Al-Bayyari, Ph.D

Role: STUDY_DIRECTOR

Al-Balqa Applied University

Locations

Nahla S Al-Bayyari

Salt, Balqa Governorate, Jordan

Countries

Jordan

References

Al-Bayyari N, Alhameedy M, Omoush R, Ghazzawi H. Exploring the effects of high protein versus high fat snacks on satiety, gut hormones and insulin secretion in women with overweight and obesity: A randomized clinical trial. Obes Pillars. 2025 Sep 27;16:100212. doi: 10.1016/j.obpill.2025.100212. eCollection 2025 Dec.

Reference Type: DERIVED

PMID: 41079153 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HF vs HP-8/2020

Identifier Type: -

Identifier Source: org_study_id