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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	Female

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04632810
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Helse Nord-Trøndelag HF
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Siren Nymo, PhDHallvard Græslie, md
Principal Investigator Affiliation	Nord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of SurgeryNord-Trøndelag Hospital Trust, Namsos Hospital, Clinic of Surgery
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Norway
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lipedema

Additional Details

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).

Arms & Interventions

Arms

Experimental: Ketogenic low energy diet

Ketogenic low energy diet for 8 weeks

Active Comparator: non-Ketogenic low energy diet

non-Ketogenic low energy diet for 8 weeks

Interventions

Other: - Ketogenic low energy diet

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

Other: - non-ketogenic low energy diet

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Levanger, Norway

Status

Address

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, ,

St Olavs Hospital, Trondheim, Norway