Effect of Proteins on Antioxidant Capacity

NCT06621940 | Not Yet Recruiting

• 1 other identifier: ERU-BES-AOC-02
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on early antioxidant response in women. The definition of HPDs cannot be determined exactly. It is defined differently by various scientific authorities. However, protein is targeted to be approximately 30% of total energy in HPD. It has been determined that HPDs increase satiety, thermogenesis, and provide body weight loss and maintenance of loss. In general, there is evidence that HPD provides more body weight loss in a short time compared to low protein diets. It has been emphasized that the effect of high protein diet on weight loss is related to creating satiety, thus decreasing food intake and increasing thermogenesis. However, the physiological, biochemical and molecular events that occur due to HPD feeding have not been fully understood and the results have not been explained. The effects of HPDs have been determined to last from 1 to 6 days to 6 months. The absence of any study in the literature on the short-term and long-term effects of HPD on oxidative events in humans reveals the original value of this study. Therefore, considering that long-term HPD feeding may increase the risk of cardiovascular disease, blood pressure, and blood lipid levels, the effect of short-term HPD feeding on antioxidant capacity will be investigated in order to avoid these side effects. The planned interviews and measurements for this prospective analytical study will be carried out in the Anthropometry laboratory of the Department of Nutrition and Dietetics, Faculty of Health Sciences at Erciyes University, and blood analyses will be carried out in the Betül Ziya Eren Genome and Stem Cell Research Center laboratory and the Erciyes University Gülser and Dr. Mustafa Gündoğdu Comprehensive Service Laboratory. Healthy female individuals will be applied HPD for 10 days and a normal diet for 10 days as a control. As a result of the applied diets, the expected results of the study are that HPD will cause a decrease in body weight and an increase in lean body mass, even for a short time, and that HPD will have an effect on diet-induced inflammation, cause oxidative stress, affect antioxidant capacity and cause changes in the measured parameters.

Conditions

High Protein Dietary Intake

Keywords

High protein diet; Antioxidant capacity; Oxidative stress; Inflammation

Outcome Measures

Primary Outcomes (2)

• Antioxidant capacity after high protein diet

  After the diet, antioxidant biomarkers \[antioxidant status (TAS), total oxidant status (TOS)\] will be measured in the blood. Lower values represent a worse outcome.

  Day after diet end

• Anthropometric measurements after high protein diet

  Anthropometric measurements will be made after the diet. An increase in anthropometric measurements represents a worse result.

  Day after diet end

Study Arms (2)

High Protein Diet

EXPERIMENTAL

The energy composition of the high protein diet will be calculated as 40% carbohydrate, 30% protein and 30% fat. It will be stated that individuals should not eat anything other than the foods to be sent during the weeks of the diet.

Other: High Protein Diet

Normal Protein Diet

EXPERIMENTAL

The energy composition of the high protein diet will be calculated as 55% carbohydrate, 15% protein and 30% fat. It will be stated that individuals should not eat anything other than the foods to be sent during the weeks of the diet.

Other: Normal Protein Diet

Interventions

High Protein Diet OTHER

Individuals will be placed on a high protein diet for 10 days.

High Protein Diet

Normal Protein Diet OTHER

Individuals will be placed on a normal protein diet for 10 days.

Normal Protein Diet

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Being between 19-45 years of age,
• Not changing physical activity throughout the study,
• Having a BMI of 18.5-24.9 kg/m2,
• Being healthy

You may not qualify if:

• Having a BMI of \<18.5 and ≥25 kg/m2,
• Having a chronic disease,
• Smoking and drinking alcohol,
• Using vitamin-mineral supplements and herbal supplements,
• Being pregnant or breastfeeding,
• Having entered menopause,
• Being on any diet.

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Inflammation

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Aslı Onur Canaydın, MsC

CONTACT

+905320649416; dyt.aslionur@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The content of the diet will be given to the participants without specifying it.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: It consists of two parallel groups receiving a high-protein diet and a normal-protein diet.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share