Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04632810 |
| Other study ID # |
93888 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 22, 2021 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
November 2023 |
| Source |
Helse Nord-Trøndelag HF |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 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.
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).
