Keywords
Fasting therapy - low calorie diet anthropometry - low-calorie diet - naturopathy
- serum lipid level
Introduction
The prevalence of overweight and obesity is increasing worldwide, amplifying concerns
over the health risks associated with this worsening problem.[[1]] In India, a recent ICMR-INDIAB study conducted in three states, namely Tamil Nadu,
Maharashtra, and Jharkhand and one Union Territory Chandigarh found that the prevalence
of generalized obesity ranged from 11.8% to 33.6% among the residents.[[2]]
The age-standardized prevalence of generalized obesity in South India was 46% (women:
47%; men: 43%). Abdominal obesity was found in 47%–51% with higher rates in women
(women: 56%; men: 35%). Development and urbanization bring with them several habits
such as physical inactivity, transport facilities (reduced walking or cycling), fast
food, and excessive intake of a high-calorie diet,[[3]],[[4]] all of which have contributed to the emergence of obesity and overweight.
Elevated levels of total and low density lipoprotein (LDL) cholesterol and low levels
of high density lipoprotein (HDL) cholesterol are important risk factors for coronary
heart disease.[[5]] Mean total cholesterol (TC) and triglycerides (TGs) concentrations were higher
in obese persons in comparison to normal weight. The conventional system of medicine
has been useful in managing weight; however, it comes with many side effects.[[6]],[[7]],[[8]] Due to this, people have been drifting to complementary and alternative systems
of medicine to find a solution for this problem. Among the naturopathy and yoga treatment
modalities, therapeutic fasting therapy, raw diet therapy, and a naturopathic based
low-calorie diet (LCD) have been practiced by Indian and Western naturopaths.[[9]],[[10]],[[11]],[[12]] Few studies suggest low and a very LCD (VLCD) are effective in weight reduction
in obese and overweight individuals.[[13]],[[14]]
Short-term water fasting therapy is beneficial in healthy individuals to reduce leptin
levels and body weight.[[15]] LCDs involve a reduction in daily caloric intake by 25%–30%. LCDs should be individualized
depending on the patient's energy requirements, the severity of the obesity, and any
accompanying diseases and treatments. Intermittent fasting (IF) involves caloric restriction
for one or several days a week, or every day as the prolongation of the overnight
fast.[[15]],[[16]] The results from this study have shown that LCDs and IF in patients with can lead
to a reduction in body fat mass and metabolic parameter improvements. These beneficial
effects arise not only from the loss of body mass, but also from the activation of
metabolic pathways specific to fasting conditions.[[17]]
In another study, a week juice fasting showed health improvement in 78% of in-patients.
In addition, fasting was well-tolerated and no serious adverse effects were reported.[[18]] Although there are studies on the beneficial effects of naturopathic-based fasting
therapy on weight reduction in healthy volunteers, there is a paucity of large-scale
randomized controlled trials (RCTs) makes it difficult to prescribe fasting with LCDs
or LCD as reliable, routine methods for successful and stable weight loss. Therefore
in the present study was conducted to see the effects of naturopathic-based fasting
therapy against a LCD therapy, on anthropometric measurements and serum lipid levels
among obese female individuals and we hypothesized that 10 days' naturopathy fasting
therapy would result in significant changes in study parameters than the LCD.
Materials and Methods
Study populations
Obese or overweight individuals who volunteered to participate were recruited through
e-mail, campus newspaper advertisements, flyers, and word of mouth in the southern
district of Karnataka and were screened. The individuals who expressed interest to
take part in the study underwent a medical examination with a detailed case history
using a structured format after the basic screening. Individuals who have been diagnosed
with a body mass index (BMI) ≥25 kg/m2 as per the criteria of World Health Organization,
aged between 18 and 40 years, individuals given a written informed consent, fasting
naïve for at least past 6 months, and individuals who were not on any hormonal medications
for the past 2 months were included in the study. Individuals with morbid obesity
and associated comorbid conditions such as drug-induced obesity (e.g., corticosteroid)
or endocrine disorders such as hypothyroidism and polycystic ovarian syndrome and
other comorbid medical conditions such as uncontrolled hypertension, hypercholesterolemia,
type I and II diabetes mellitus, pregnant, and lactating females, were excluded.
Design of the study
This study is a single-centered, single-blinded RCT. The study protocol and informed
consent form were reviewed and approved by the Institutional Ethical Committee. The
study was registered to Clinical Trials Registry-India-CTRI/2018/02/011978.
Individuals were allocated into either fasting therapy group or naturopathic LCD group
by simple randomization by computer-generated randomization table. The randomization
was maintained by a naturopathy and yoga medical professional, who were not involved
in the individual's recruitment or data collection. Consort 2010 statement is followed
to report the RCT as shown in [[Figure 1]].
Figure 1: CONSORT flow chart of the study
Fasting intervention: Naturopathic-based fasting therapy was given to the individuals
admitted to the SDM Yoga and Nature Cure Hospital, Ujire, Karnataka. Individuals were
kept away from their daily routines so that nothing could interfere with their thoughts
and emotions. They had to maintain complete physical and mental rest during the study
period with minimal activity. Throughout the intervention period, individuals were
under the supervision of a trained naturopathy and yoga physician for 10 days. During
juice fasting, the individuals were asked to remain hydrated with approximately 3
L of water per day. No other supplementary diet was given to the individuals. They
were taught yogic relaxation techniques such as deep relaxation technique with minimal
physical activity (walking). Naturopathic treatments were administered to manage the
crisis, if any, during the course of the fasting therapy such as headache, dizziness,
vomiting, and diarrhea. Individuals were advised to take enema as a colon cleansing
procedure on every day during the fasting period. Daily percentages of different macronutrients
with dietary fiber are as follows: naturopathic diet/day (carbohydrates 56.72%, protein
11.47%, fat 7.47%, and fiber 24.34%), raw diet/day (carbohydrates 48.40%, protein
11.13%, fat 9.90%, and fiber 30.57%), lemon juice with honey (lhj)/day (92.93% carbohydrates,
protein 2.02%, fat 0%, and fiber 5.05%), and mosambi juice (mj)/day (carbohydrates
83.41%, protein 7.17%, fat 2.69%, and fiber 6.73%). Fasting therapy from 3rd day to
7th day was done with LHJ. LHJ (72 kcal) was taken 4 times a day. Therefore, the total
calorie intake was 288 kcal/day. Similarly on the 8th day, fasting was done with MJ
(200 kcal) which was taken 4 times a day. Therefore, total calorie intake was 800
kcal/day.
LCD intervention group: The control group underwent a naturopathic LCD (1234 kcal/day)
for 10 days which consisted of unseasoned boiled vegetables, chapati, daliya, vegetable/fruit
salads, and sprouts. They were also involved in practicing deep relaxation techniques
with minimal physical activity. After the intervention period, fasting was administered
to subjects in the LCD group who desired to undergo fasting therapy. Details of the
diet composition and calories of both the groups are provided in [[Table 1]].
Table 1: Detailed food composition of fasting group and low calorie diet group for 10 days
Outcome measures
All the individuals in fasting therapy and naturopathic LCD group were assessed by
a naturopathy and yoga physician with the following parameters at the baseline and
after 10 days treatment. The outcome assessment was conducted by a doctor who was
blind to the study.
Anthropometric variables
Body weight was measured with light clothing and without shoes using a digital weighing
machine (Essae, Eeroka ltd) and height was measured using a calibrated stadiometer.
BMI was measured using the equation BMI = weight (kg)/height 2 (m2). Waist circumference
(WC) was measured midway between the inferior costal margin and the iliac crest using
a Gulick Anthropometric tape, U. S. A. The circumference of the hip was measured around
the pelvis at the point of maximal protrusion of the buttocks. Finally, the waist
to hip ratio (WHR) was measured to assess the body fat distribution.
Assessment of serum lipid profiles and leptin of obese patients
Venous blood (7 ml) was drawn into evacuated, serum separator tubes after 12 h fasting.
Complete blood cell count was performed on EDTA-anticoagulated blood using an electronic
counter (SE 9000, Sysmex, Kobe, Japan). All lipid profiles were measured with an automatic
chemical analyzer (Hitachi 747, Hitachi, Tokyo, Japan) within 4 h after collection.
Serum TGs, TC, HDL and LDL concentrations were analyzed by enzymatic colorimetric
methods using TG GPO-PAP reagents (Roche Diagnostics GmbH, Mannheim, Germany), SICDIA
L T-CHO reagents (Eiken Chemical Industries, Tokyo, Japan), Cholestest-LDL reagents
(Daiichi Chemicals, Tokyo, Japan), and Cholestest-HDL reagents (Daiichi Chemicals),
respectively.[[17]],[[19]],[[20]],[[21]] Serum leptin level analyzed with a sandwiched enzyme-linked immunosorbent assay
(ELISA) (ELX 800 Absorbance Microplate Reader [BioTek, Winooski, USA] and Assay Max
Human Leptin ELISA Kit [Assaypro, St. Charles, MO, USA]).
Data analysis
The distribution of the data was checked for normality using Kolmogorov–Smirnov test.
Since the data was not normally distributed nonparametric tests were used. Continuous
variables were assessed for the baseline differences between the groups using Mann–Whitney
U-test. Wilcoxon signed rank test was done to compare pre- and post-scores within
the groups. Changes in serum lipid profile variables due to the diets within each
group were tested using Student's paired t-tests. Two-sided P values were considered
statistically significant at P < 0.05. Results are expressed as means ± standard deviation
unless otherwise indicated. All data were analyzed using SPSS 22 (IBM SPSS Inc., Chicago,
IL, USA).
Results
Demographic characteristics
Of the total 135 obese or overweight persons screened, 100 individuals included into
the study after studying inclusion and exclusion criteria and were randomly allocated
into either fasting therapy (n = 48) or LCD intervention (n = 52) group to prevent
bias baseline characteristics such as weight, age, sex, site-, and race-adjusted.
The baseline and 10th day follow-up assessments were available in the 42 individuals
each from the both group. Details are delineated in the Consort Flow Chart [[Figure 1]].
Variables such as sociodemographic and illness characteristics were compared at the
baseline in both the groups as shown in the [[Table 2]].
Table 2: Detailed food composition of low calorie diet group and first day of fasting group
Effect of fasting therapy and low calorie diet therapy on obesity/overweight
The difference present within thr groups was performed by using Wilcoxon signed-rank
test, which indicates both the groups, did better in all the parameters [[Table 3]]. However, the greater changes were observed in the fasting group in comparison
with the LCD group. Results suggest that there was a significant difference between
group with respect to changes in BMI (6.40), weight (−6.04), WC (−3.13), Height circumference
(−2.34), and WHR (−2.34) with P < 0.05 [[Table 4]].
Table 3: Descriptive statistics of sociodemographic and illness characteristics at the baseline
(n=42)
Table 4: List of parameters changes in fasting therapy and low-calorie diet group (baseline
to 10th day follow up)a
In this study, 5.24% of weight reduction was observed in the fasting group (mean 3.96)
after 10 days of intervention. Furthermore, 2.57% of weight reduction was observed
in the naturopathic LCD after 10 days of the intervention. These results indicate
greater reductions in weight with short-term fasting therapy. Furthermore, significant
(P < 0.005), mean reduction of serum lipid profile) (−27.43%), TGs (−13.05%), and
LDL (−20.9%) in the treated group were statistically significant (P < 0.001), whereas
serum HDL (2.32%) was increased but insignificantly (P > 0.001) when compared with
the nontreated group [[Table 5]]. Though reduction of serum leptin levels in fasting group is high (47.1%) than
to compared LCD (24.12%) but results were insignificant.
Table 5: Lipid profiles of obese patients (n=42)
Discussion
The primary goal of obesity management in the primary health care is to lose 5%–15%
of the initial body weight.[[17]] Our results suggest that changes in BMI, weight, hip circumference, WC and WHR
were significantly different in the two groups (fasting and LCD), except for serum
leptin and results comparison within-group showed that significant reduction in the
study parameters in both groups; however, greater changes were observed in the fasting
group than compared to LCD group.
Weight reduction of 5.24% obtained in this study is consistent with the previous studies.
Fasting for 14 days with fermented medicinal herbs and carbohydrates (400–600 kcal/day)
resulted in Mean 5.16 weight loss among 26 subjects.[[19]] Another study reported that the traditional dietary approach to weight reduction
brings about greater weight loss with 600 kcal/day diet in comparison with a LCD (1200
kcal/day).[[20]]
A recent meta-analysis[[21]] reported more weight loss with low carbohydrate diet (mean 8.73 kg) at 6 months
and 7.25 kg at 12 months, whereas the reduction in weight loss in low-fat diet was
7.99 kg at 6 months and 7.27 kg at a 12 month follow-up. Long-term studies showed
3 times more weight loss amongst subjects who consumed low-fat and fibre-rich foods
in comparison to low-fat food consumption alone (−3.4 kg vs. −1.0 kg). In the present
LCD study group, weight reduction of 2.57% observed which is consistent with the results
of previous studies.
Wood[[8]] concluded that weight loss induced by carbohydrate restriction favourably alters
the secretion of plasma LDL cholesterol and TGs, significantly reduced by 8.9 and
38.6%, respectively. In contrast, plasma HDL cholesterol concentrations were increased
by 12%. In addition, they were associated with decreased risk for atherosclerosis
and coronary heart disease. It has been suggested that low-carbohydrate high-protein
diets and their potential impact on the practice of cardiology, it is clear that people
who consume such diets have a reduced intake of calories, resulting in a predictable
degree of weight loss. These diets induce a moderate level of ketosis have been shown
to improve the lipid profile overall.
In addition VLCD program enabled obese patients to lose an average weight of 35.1
kg in 26 weeks.[[22]] These weight losses were accompanied by clinically significant decreases in obesity-related
risk factors, including a 15% reduction in serum TC and 17% reduction in LDL cholesterol.
Results from our study shown that significant reduction in serum lipid profile TC
(27.43%), TG (13.05%), LDL (20.9%) with (P < 0.001), whereas, reduction of serum HDL
was (2.32%) which is insignificant [[Table 5]].
A study showed a significant change in serum leptin levels with short-term fasting
for 52 h, in this study; leptin mean reduction was from 31 to 12 ng/ml (61.3%) in
obese individuals and from 11 to 4 ng/ml (63.64%) in normal weight individuals.[[17]] The results suggest a reduction in leptin levels were related to regulatory factors
other than changes in body fat mass.[[17]] Furthermore, another study showed 20% reduction in serum leptin levels after a
24 h fasting in obese individuals along with a reduction in BMI.[[23]] In our study, reduction of leptin levels was observed in both the fasting group
and naturopathic LCD group, but no difference was observed between the groups. Percentage
of reduction of leptin levels in fasting group (47%) and LCD group (24.12%).
Possible mechanisms behind these changes in weight loss and other anthropometric measurements
in both fasting therapy and LCD were as follows. Lemon juice used in fasting and naturopathic
diet group is enriched with Vitamin C. Lemon juice with honey has showed to be beneficial
by reducing BMI and weight in healthy subjects.[[22]] Interestingly, Vitamin C levels are inversely related to the body mass indicating
obese individuals oxidize 30% more fat during a moderate exercise regimen than individuals
with Vitamin C deficiency.[[24]] Increased intake of whole grains, fruits, and vegetables are beneficial in obesity
because whole grains and vegetables have low glycemic index and fruits contain more
fiber, anti-oxidant, phytochemicals, and minerals.[[25]] Likewise, low fat and high fiber diet consumption enhances satiety and reduces
hunger.[[26]] The presence of undigested carbohydrates in whole grains gives bulk to the fecal
matter and reduces the intestinal transit time, thereby reducing the risk of weight
gain.[[27]] Furthermore, consumption of a minimum 48 g of whole grains/day is beneficial in
weight maintenance (less weight gain from 8 to 13 years) and vascular disease prevention.[[28]],[[29]] Short term fasting for 10 days is more beneficial and does not result in any adverse
effects because fasting process does not affect the vital organs.[[30]] Furthermore, there is an increased beta-oxidation observed during fasting.[[31]] VLCD (450–800 kcal/day) has many advantages such as rapid weight loss, which acts
as a motivating factor for obese persons and also the mild ketosis formation suppresses
the hunger and slows down the protein loss.[[32]] Furthermore, VLCD should be used for <16 weeks because of the adverse effects related
to ketosis formation.[[33]] Breaking the fast is considered equally important in Naturopathic philosophy and
practice.[[34]] It was done with Mosambi (sweet lime) juice consumption for a day as it is thicker,
having more fiber content so that the individual's system could be prepared for the
subsequent return to raw diet followed by a boiled diet.
Conclusions
The present study shows that the effects of two types of treatment and weight loss
due to change of fasting with VLCD were additive: the total effect of slimming on
reducing serum levels of TC, LDL cholesterol, and TGs could be ascribed for more than
50% to weight loss per se In conclusion, our findings support beneficial effects of
a fasting with VLCD over LCD on obese subjects. The considerable additive effects
of weight loss per se underscore the importance of establishing successful dietary
treatment and weight maintenance programs for obesity. However, long-term practice
and its effect with respect to weight loss adherence and prevention of overweight
or obesity with these interventions should be tested in future with robust studies.
Limitations of the study
Follow-up was not done after 10 days of intervention and absence of an active control
arm were the main limitations of the study. Although VLCD is beneficial in the short-term
reduction of weight, the risk of weight gain is more in this due to binge eating[[16]],[[34]] In addition, body loses large volume of water and also muscle mass for some extent.
Once the obese or overweight persons are back on a regular diet, the percentage of
weight loss is smaller. Therefore, future directions should focus on long-term sustained
adherence of these different types of diets on weight loss.
