Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema (Lipodiet)

November 22, 2023 updated by: Helse Nord-Trøndelag HF

The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema

Lipedema is a female progressive fat disorder, characterized by a symmetrical increase in subcutaneous adipose tissue in the lower extremities with the exception of the waist. The condition is often misdiagnosed and underdiagnosed. The etiology is poorly understood. Affects about 11% of all women and may lead to pain and immobility. The pathophysiology may be related to sex hormones and inflammatory response. Lipedema fat has been reported not to respond to lifestyle changes or bariatric surgery, both in terms of weight loss and symptom reduction; including pain and quality of life. Clinical research on the effect of dietary interventions on lipedema does not exist, but a pilot study with a ketogenic diet showed a significant reduction in pain regardless of weight loss. The aim of the research project will be to investigate whether a ketogenic diet can be a treatment option for patients with lipedema. Therefore, a randomized controlled trial will be conducted to compare the effects of two diets. 1) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet for 8 weeks. Pain and quality of life will be mesured at start and immediately after the intervention. The hypothesis is that a ketogenic diet may reduce pain and improve quality of life.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Study design RCT comparing a low-energy ketogenic diet to a non-ketogenic low-energy diet (non-keto) in females with lipedema. This study was approved by the Reginal Ethical Committee (REK 93888) All participants have to provided written informed consent in line with the Helsinki Declaration, before entering the study. Participants will be randomized by block randomization with stratification by BMI categories.

Study population Females diagnosed with lipedema, aged 18-75 years old, and a BMI between 30-45 kg/m2, will be invited to participate in this study. Participants had to be diagnosed with lipedema by physiotherapists before inclusion. Inclusion criteria includs weight stability for the last three months (±3 kg).

Dietary interventions Diets were matched for energy (1200 kcal/day) and protein, but differed in carbohydrate (CHO) and fat content.

The dietary plans are adjusted with respect to food preferences, intolerances, and allergies. The participants will be asked not to change their physical activity levels throughout the study period.

Compliance Participants will have weekly follow-ups. Participants will be asked to fill out daily food records throughout the intervention period.

Ketostix will be used in the weekly follow-ups to measure urinary acetoacetate (AcAc). If the participants in the keto group were outside of ketosis, or participants in the non-keto group in ketosis, >2 times throughout the study period, they were excluded from the per-protocol (PP) analysis.

Outcome variables

The following variables were assessed at baseline and at the end of the intervention:

Anthropometrics and body composition Height and weight will be measured at baseline. Body composition will be assessed in fasting state with Bioelectrical Impedance Analysis before and after the intervention..

Pain Pain will be assessed with the brief Pain Inventory. The participants rated their pain in a numerical rating scale (NRS), where 0 = no pain and 10 = Worst imaginable pain. The BPI assesses pain intensity: strongest pain, weakest pain, average pain, pain now, pain severity score using an average of pain intensity domains, and pain inference from daily activities, mood, walking, regular work, relationships, sleep and life joy. A pain inference score is also computed as the average of all pain inference domains.

Three different questionnaires are used to assess Quality of life. RAND-36. The Impact of Weight on Quality of Life-Lite (IWQOL-Lite) q and the Lymphoedema Quality of Life (LYMQOL).

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • 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 Contact

Study Contact Backup

  • Name: Heidi Annet Holm

Study Locations

      • Levanger, Norway
        • Levanger Hospital, Nord-Trøndelag Hospital Trust
      • Trondheim, Norway
        • St Olavs Hospital

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

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with lipedema by skilled physical therapists
  • Body mass index > 30kg/m2 and < 45kg/m2
  • Stable weight over the last three months (+2-3kg)
  • Not currently dieting to lose weight
  • Willing to meet for follow-ups every second week during the intervention
  • Willing to sign an informed consent before entering the study

Exclusion Criteria:

  • Pregnant or breast feeding
  • History of infectious diseases
  • Medication known to affect obesity
  • Enrolled in any other obesity treatment
  • Having had bariatric surgery.
  • Kidney disease is excluded
  • History of psychological disorders
  • Not mastering a Scandinavian language
  • Being mentally disabled
  • Malign disease
  • Diabetes
  • Any disease that leads to dietary advice that is not consistent with intervention advice

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketogenic low energy diet
Ketogenic low energy diet for 8 weeks
Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 75g (25E%), protein 60 g (20E%), fat 73 g (55E%) in 8 weeks
Active Comparator: non-Ketogenic low energy diet
non-Ketogenic low energy diet for 8 weeks
Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 180g (60E%), protein 60 g (20E%), fat 27 g (20E%), in 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain intensity
Time Frame: 8 weeks
A difference in mean pain score of 2 units on a continuous scale from 0 to 10 on a visual analog scale (VAS) is considered clinically interesting
8 weeks
change in quality of life
Time Frame: 8 weeks
Likert Scale
8 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Siren Nymo, PhD, Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
  • Study Director: Hallvard Græslie, md, Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery

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)

March 22, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 93888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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