Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths

Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study

A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.

Study Overview

• Status: Completed
• Conditions: Adolescent Anorexia Nervosa
• Intervention / Treatment: Other: ginger powder footbath; Other: warm water only footbath

Detailed Description

This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden Württemberg
    • Filderstadt, Baden Württemberg, Germany, 70794
      • Arcim Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• main diagnosis: Anorexia nervosa
• written informed consent of participants and legal guardians

Exclusion Criteria:

• other eating disorder diagnosis apart from Anorexia nervosa
• known allergic reaction to ginger

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Warm water with ginger powder footbath; Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.	Other: ginger powder footbath; 38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine
ACTIVE_COMPARATOR: Warm water only footbath; Participants who receive a warm water only footbath four times a week over a six-week period.	Other: warm water only footbath; 38-40° C warm water footbath without any additive reaching up to mid-calf level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chnge in Subjective feeling of overall warmth	Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire	Baseline (pre intervention), 6 weeks after baseline (post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core body temperature	Core body temperature measured using an infrared tympanical thermometer as used in clinical routine	Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up
Face surface temperature	Surface temperature in the face measured using high-resolution infrared thermography	Baseline (pre intervention) and 6 weeks after baseline (post intervention)
Feet surface temperature	Surface temperature at the feet measured using high-resolution infrared thermography	Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Hand surface temperature	Surface temperature on the hands measured using high-resolution infrared thermography	Baseline (pre intervention) and 6 weeks after baseline(post intervention)
Abdomen surface temperature	Surface temperature at the abdomen measured using high-resolution infrared thermography	Baseline (pre intervention) and after 6 weeks (post intervention)
24-hour feet surface temperature	24 hour surface temperature at the feet measured using a surface data-logger (i-Button TM)	Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention)
24-hour hand surface temperature	24 hour surface temperature on the hands measured using a surface data-logger (i-Button TM)	Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour abdomen surface temperature	24 hour surface temperature at the abdomen measured using a surface data-logger (i-Button TM)	Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
24-hour torso surface temperature	24 hour surface temperature at the upper torso measured using a surface data-logger (i-Button TM)	Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention)
Body Mass Index	Body Mass Index (BMI) Calculated as (Weight in Kg)/〖(Height in m)^2〗	Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up
Pulse Transit Time (PTT)	PTT in ms, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Perfusion Index (PI)	PI, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Peak to Peak Time (PPT)	Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SlopeInW1	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention)
SlopeInW2	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW3	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
SlopeInW4	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Stiffness Index	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Reflection Index	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTX	TimeTX in ms (millisecond), measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTY	TimeTY in ms, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTYTX	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAX	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
AreaAY	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAYAX	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAV	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
AreaAW	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotAWAV	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotTVTW	Measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTV	TimeTV in ms, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
TimeTW	TimeTW in ms, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT1	Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MinT2	Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
MaxT1	Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the first peak	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
MaxT2	Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the second peak	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
QuotHRRespRate	Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
Heart rate	beats per minute (bpm) measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Respiratory rate	measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
SDNN (standard deviation of normal to normal)	Standard deviation of normal to normal beats, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
RMSSD (Root mean square of successive differences)	Root mean square of successive differences, measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
pNN50	Number of pairs of successive heart rate intervals that differ by more than 50 ms	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
HF (high frequency)	Area under the curve between the frequency of 0.15 to 0.4Hz measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention)
LF (low frequency)	Area under the curve between the frequency of 0.04 to 0.15Hz measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
LF/HF-Ratio	Ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz), measured with the GeTeMed Vitaguard 3100	Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention)
Pittsburgh sleep quality index	Scores of the PSQI (Pittsburgh sleep quality index)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Eating Disorder Inventory -2	Scores of the EDI-2 (Eating Disorder Inventory)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Eating Disorder Examination- Questionnaire	Scores of the EDE-Q (Eating Disorder Examination)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Becks Depressions Inventar	Scores of the BDI-II (Becks Depression Inventar)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Hospital Anxiety and Depression Scale subscale Anxiety	Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Hospital Anxiety and Depression Scale subscale Depression	Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Body Image State Scale	Mean of all six item values (range from 0-9) with higher values indicating a positive body image state of the BISS (Body Image State Scale)	Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up
Positive And Negative Affect Schedule	Scores of the PANAS-X (Positive and negative affect schedule)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Short Form Health Survey 12	Scores of the SF-12 (Short Form 12)	Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up
Basler Befindlichkeits Skala	Scores of the BBS (Basler Befindlichkeits Skala =basler mood questionnaire)	Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up
Body Shape Questionnaire	Scores of the BSQ (Body Shape Questionnaire)	Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up

Collaborators and Investigators

• Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Collaborators: Filderklinik, Filderstadt, Germany
• Investigators: Principal Investigator: Jan Vagedes, Dr. med., Arcim Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 8, 2019
• Primary Completion (ACTUAL): February 26, 2020
• Study Completion (ACTUAL): February 27, 2020

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Thermoregulation; Anorexia; Anthroposophic medicine; Eating disorders; Footbath; Ginger powder; Thermogenic substances; External applications
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Anorexia; Anorexia Nervosa
• Other Study ID Numbers: ANS_03

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