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

• Sponsor: Helse Nord-Trøndelag HF (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04632810
• Collaborator: Norwegian University of Science and Technology (Other), St. Olavs Hospital (Other), Vanderbilt University Medical Center (Other)
• Enrollment: 81
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 24.3
• Patients Per Site: 40.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 three diets. 1) enery balanced (weight maintenance) ketogenic diet, 2) energy-restricted ketogenic diet and 3) energy-restricted low-fat non-ketogenic diet with a view of 10% weight loss within 10 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.

Condition or Disease	Intervention/Treatment	Phase
Lipedema	Other: Ketogenic diet until reaching 10% weight loss; Other: non-ketogenic diet until reaching 10% weight loss; Other: Ketogenic eucaloric diet for weight stability	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Norwegian LIPODIET Study: Effect of Ketosis on Pain and Quality of Life in Patients With Lipedema
• Actual Study Start Date: Mar 22, 2021
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketogenic diet + weight loss	Other: Ketogenic diet until reaching 10% weight loss; Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 50g (17E%), protein 60 g (20E%), fat 84 g (63E%), until reaching 10% weight loss (approximately 10weeks).
Active Comparator: non-Ketogenic diet + weight loss	Other: non-ketogenic diet until reaching 10% weight loss; Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 150g (50E%), protein 60 g (20E%), fat 40 g (30E%), until reaching 10% weight loss (approximately 10weeks).
Active Comparator: Ketogenic eucaloric diet	Other: Ketogenic eucaloric diet for weight stability; Participants will follow a low-calory-high-fat diet for 10 weeks. Carbohydrates10E%, protein 20E% and fat:70E%. Dietary plans will be based on individual measurement of energy needs by resting metabolic rate and physical activity level.

Outcome Measures

Primary Outcome Measures

1. change in pain intensity [11 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

2. change in quality of life [11 weeks]

   Likert Scale 1 best to 4 worst

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Levanger Hospital, Nord-Trøndelag Hospital Trust	Levanger		Norway
2	St Olavs Hospital	Trondheim		Norway

Sponsors and Collaborators

• Helse Nord-Trøndelag HF
• Norwegian University of Science and Technology
• St. Olavs Hospital
• Vanderbilt University Medical Center

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helse Nord-Trøndelag HF
• ClinicalTrials.gov Identifier: NCT04632810
• Other Study ID Numbers: 93888
• First Posted: Nov 17, 2020
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Helse Nord-Trøndelag HF: Diet therapy; Ketosis; Pain; Weight loss
• Additional relevant MeSH terms: Lipedema; Ketosis

Study Results

No Results Posted as of Mar 23, 2022