Effect of Protein on Endoplasmic Reticulum Stress

NCT06621901 | Completed

• 1 other identifier: ERU-BD-AOC-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to provide information about the effect of short-term high protein diet (HPD) feeding on endoplasmic reticulum stress. The definition of HPDs cannot be determined exactly. They are defined differently by various scientific authorities. However, the target is for protein 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 HPDs provide 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 reducing food intake and increasing thermogenesis. However, the physiological, biochemical and molecular events that occur due to HPD feeding are not fully understood and the results have not been explained. It has been determined that the effects of HPDs last between 1 and 6 days and 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 endoplasmic reticulum stress will be investigated in order to avoid these side effects. Blood analyses planned for this prospective analytical study will be performed in GENKÖK Laboratory. Healthy individuals will be administered 10 days of HPD and a 10-day normal diet as a control.

Conditions

Effect of High Protein Diet on Endoplasmic Reticulum Stress

Keywords

Endoplasmic reticulum stress; High protein diet; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Endoplasmic reticulum stress after high protein diet

  After the diet, endoplasmic reticulum stress parameters (GRP78, PERK, Nrf2 and GPx-1) will be measured in the blood.

  Day after diet end

Study Arms (1)

Fixed-Sequence Dietary Intervention

EXPERIMENTAL

All participants received the same fixed sequence of dietary interventions. Participants first received a high-protein diet for 10 days (40% carbohydrate, 30% protein, and 30% fat), followed by a two-week wash-out period during which they maintained their habitual dietary intake. They subsequently received a normal-protein diet for 10 days (55% carbohydrate, 15% protein, and 30% fat). Participants were instructed not to consume foods or beverages other than those permitted by the study protocol during both intervention periods. The intervention order was not randomized.

Other: High Protein Diet; Other: Normal Protein Diet

Interventions

High Protein Diet OTHER

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

Fixed-Sequence Dietary Intervention

Normal Protein Diet OTHER

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

Fixed-Sequence Dietary Intervention

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• 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
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Diet, High-Protein

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study was classified as open-label because all participants received the same fixed intervention sequence. However, laboratory personnel assessing biochemical, oxidative, antioxidant, and inflammatory outcomes were blinded to the dietary intervention periods. Blood samples were coded before analysis and decoded only after all assays had been completed.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant of Department of Nutrition and Dietetics

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

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: September 25, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)