Impact of Optimised Protein Intake on Household Work Limitations and Disability in Rheumatoid Arthritis

July 27, 2026 updated by: Satguru Partap Singh Hospitals

The goal of this clinical trial is to learn if optimised protein intake improves household work capacity and overall functional status in women with rheumatoid arthritis. It will also assess the safety and tolerability of dietary protein supplementation. The main questions it aims to answer are:

Does optimised protein intake reduce household work limitations measured by the Household Work Limitations Questionnaire (HOWL-Q)?

Does optimised protein intake improve overall functional disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI)?

What side effects or tolerability issues do participants experience with dietary protein modification and supplementation?

Researchers compared participants receiving structured dietary counselling and protein supplementation (targeting 1.0 g/kg/day) to their baseline protein intake to determine if the intervention improves functional outcomes in women with stable rheumatoid arthritis on disease-modifying antirheumatic drugs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Ludhiana, Punjab, India, 141003
        • Satguru Partap Singh Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Women aged equal to or more than 18 years with rheumatoid arthritis diagnosed according to American College of Rheumatology/European League Against Rheumatism 2010 criteria

Exclusion Criteria:

Males

Unstable disease requiring DMARD modification during the study period

Overlap connective tissue disease

Chronic kidney disease stage 3 or above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protein Optimisation Improves Household Work and Functional Status in RA
Participants received a 12-week dietary intervention comprising two components: (1) Individualised dietary counselling in preferred language (Hindi, Punjabi, or English) promoting increased protein-rich foods including plant-based sources (legumes, soybean, nuts, seeds) and animal-based sources (eggs, milk, yogurt, paneer, meat, fish) within cultural dietary preferences; (2) Commercial protein supplementation (whey protein isolate 20-25g per serving or fortified nutritional beverages ≥15g protein per serving) for participants demonstrating resistance to dietary modification alone. Intervention targeted 1.0 g/kg/day protein intake. All participants maintained unchanged disease-modifying antirheumatic drug regimens throughout. Assessments performed at baseline and 12 weeks.
Dietary supplement: Protein Optimisation through Dietary Counselling and Supplementation
Dietary Protein Optimisation Intervention targeting 1.0 g/kg/day. Two components: (1) Individualised dietary counselling promoting increased protein-rich foods including legumes, soybean, nuts, seeds, eggs, milk, yogurt, paneer, and fish, tailored to cultural dietary preferences and delivered in Hindi, Punjabi, or English; (2) Commercial protein supplementation (whey protein isolate 20-25g/serving or fortified nutritional beverages ≥15g protein/serving) for participants with dietary modification resistance. Administered over 12 weeks. All participants maintained stable disease-modifying antirheumatic drug regimens throughout. Dietary assessment via 3-day recall at baseline and 7-day recall at 12 weeks.
Other Names:
  • Dietary Protein Optimisation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Household Work Limitations measured by Household Work Limitations Questionnaire (HOWL-Q)
Time Frame: 12 weeks
Household Work Limitations measured using Household Work Limitations Questionnaire (HOWL-Q). A 41-item instrument assessing functional limitations across five domains: housekeeping, object interaction, care for others, personal motion and transportation, and manual dexterity. Each item scored 0-3; domain scores calculated as highest item score per domain; global HOWL-Q score transformed to 0-10 scale (0=best, 10=worst). Primary outcome: change from baseline to 12 weeks. HOWL-Q captures household-specific functional limitations not measured by generic disability scales (HAQ-DI), directly relevant to women's household responsibilities and quality of life.
12 weeks
Change in Overall Functional Disability measured by Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame: 12 weeks
Overall Functional Disability measured using Health Assessment Questionnaire-Disability Index (HAQ-DI). An 8-domain self-report instrument measuring disability across dressing, arising, eating, walking, hygiene, reach, grip, and activities of daily living. Each domain scored 0-3; final score calculated as mean of eight domains (range 0-3), with lower scores indicating better function. Minimally clinically important difference 0.22 points. Primary outcome: change from baseline to 12 weeks. HAQ-DI demonstrates excellent test-retest reliability (intraclass correlation >0.95) and internal consistency (Cronbach's alpha >0.90), established as standard functional disability measure in rheumatoid arthritis research.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Satguru Partap Singh Hospitals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manmeet Singh, MBBS, Satguru Partal Singh Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DMS/SPS-I/2024/96

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant-level data (PDF) with HAQ-DI, HOWL-Q, DAS28 category, protein intake, adherence.

IPD Sharing Time Frame

21-07-2026 to 20-07-2031

IPD Sharing Access Criteria

Public via OSF under CC BY 4.0; citation required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Study Data/Documents

  1. Individual Participant Data Set

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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