Diets for Reducing Abdominal Fat in Obesity
((HDLS2) Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Hawaii
Must not be taking: Anti-estrogens, Anti-androgens, Insulin
Disqualifiers: Pregnancy, Diabetes, Thyroid conditions, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests a diet where people eat much less for a few days and follow a healthy Mediterranean diet for the rest of the time. It targets middle-aged adults from specific ethnic groups with high levels of harmful fat. The goal is to encourage the body to burn more fat, especially around the belly and liver.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are taking anti-estrogen or anti-androgen medications, or insulin for diabetes, you may not be eligible to participate.
What data supports the effectiveness of the treatment IER+MED for reducing abdominal fat in obesity?
Research shows that intermittent energy restriction (IER) is an effective strategy for managing obesity, producing weight loss comparable to continuous energy restriction (CER). Additionally, the Mediterranean diet is known for its health benefits, including weight management, which suggests that combining IER with a Mediterranean diet could be effective for reducing abdominal fat.12345
Is the combination of intermittent energy restriction and a Mediterranean diet safe for humans?
Research indicates that combining intermittent energy restriction with a Mediterranean diet is generally safe for humans, with no major adverse effects reported in studies. Participants adhered well to the diet, and it was found to be acceptable and effective in reducing body fat and improving liver function.16789
How is the IER+MED treatment different from other treatments for reducing abdominal fat in obesity?
The IER+MED treatment combines intermittent energy restriction (IER), which involves alternating periods of eating less with normal eating, with the Mediterranean diet, known for its heart-healthy ingredients like olive oil, fruits, and vegetables. This approach is unique because it merges the benefits of intermittent fasting with the nutritional advantages of the Mediterranean diet, potentially offering a more sustainable and effective way to reduce abdominal fat compared to traditional continuous calorie restriction.1691011
Eligibility Criteria
Adults aged 35-69 with a BMI of 25-40 and abdominal obesity (VAT ≥90 cm2 for men, ≥80 cm2 for women), who are non-smokers, drink little alcohol, have no serious health issues or recent substantial weight changes. Must be East Asian, Native Hawaiian/Pacific Islander or White ethnicity and fully vaccinated against COVID-19.Inclusion Criteria
DXA VAT ≥90 cm2 for men and ≥80 cm2 for women
I have taken antibiotics in the last 3 months.
Fully vaccinated for COVID-19
See 12 more
Exclusion Criteria
I have diabetes and am on insulin treatment.
I cannot walk for up to an hour each day.
Contraindication to MR imaging (e.g. pacemaker, claustrophobia, metal implants)
See 7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants follow either the IER+MED or MED/DER diet plan for 24 weeks, with dietary and physical activity counseling sessions.
24 weeks
4 in-person visits, 12 remote meetings
Follow-up
Participants are monitored for long-term effects on body weight and adiposity, including DXA scans and BMI measurements.
24 weeks
2 visits (in-person)
Treatment Details
Interventions
- IER+MED (Behavioral Intervention)
- MED/DER (Behavioral Intervention)
Trial OverviewThe study is testing whether combining Intermittent Energy Restriction (IER) with the Mediterranean diet (MED) is more effective than daily energy restriction (DER) with MED in reducing belly fat and improving cancer-related markers over six months.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Mediterranean diet (MED) + daily energy restriction (DER) or MED/DERExperimental Treatment1 Intervention
The MED/DER group intervention will restrict 20% energy (25%, 45% and 30% distribution of protein, carbohydrate, and fat, respectively) continuously. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).
Group II: Intermittent energy restriction (IER) + Mediterranean diet (MED) or IER+MEDExperimental Treatment1 Intervention
The IER+MED group intervention will be to restrict 70% energy (25%, 45% and 30% distribution of protein, carbohydrate, and fat, respectively) on 2 days and follow a MED diet (25%, 45%, 30%) and meet their estimated energy requirement (EER) for the other 5 days each week. This would be equivalent to an over-all 20% daily energy restriction. Participants will also be asked to follow a moderate exercise program (1 hour of walking five days a week).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Hawaii Cancer CenterHonolulu, HI
Loading ...
Who Is Running the Clinical Trial?
University of HawaiiLead Sponsor
National Institutes of Health (NIH)Collaborator
University of Hawaii Cancer Research CenterCollaborator
National Cancer Institute (NCI)Collaborator
References
Intermittent Energy Restriction Is a Feasible, Effective, and Acceptable Intervention to Treat Adolescents with Obesity. [2023]Intermittent energy restriction (IER) is an effective obesity management strategy in adults.
Intermittent fasting interventions for treatment of overweight and obesity in adults: a systematic review and meta-analysis. [2022]To examine the effectiveness of intermittent energy restriction in the treatment for overweight and obesity in adults, when compared to usual care treatment or no treatment.
Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. [2021]The current obesity epidemic is staggering in terms of its magnitude and public health impact. Current guidelines recommend continuous energy restriction (CER) along with a comprehensive lifestyle intervention as the cornerstone of obesity treatment, yet this approach produces modest weight loss on average. Recently, there has been increased interest in identifying alternative dietary weight loss strategies that involve restricting energy intake to certain periods of the day or prolonging the fasting interval between meals (i.e., intermittent energy restriction, IER). These strategies include intermittent fasting (IMF; >60% energy restriction on 2-3 days per week, or on alternate days) and time-restricted feeding (TRF; limiting the daily period of food intake to 8-10 h or less on most days of the week). Here, we summarize the current evidence for IER regimens as treatments for overweight and obesity. Specifically, we review randomized trials of ≥8 weeks in duration performed in adults with overweight or obesity (BMI ≥ 25 kg/m2) in which an IER paradigm (IMF or TRF) was compared to CER, with the primary outcome being weight loss. Overall, the available evidence suggests that IER paradigms produce equivalent weight loss when compared to CER, with 9 out of 11 studies reviewed showing no differences between groups in weight or body fat loss.
Effects of intermittent (5:2) or continuous energy restriction on basal and postprandial metabolism: a randomised study in normal-weight, young participants. [2022]Intermittent energy restriction (IER) may overcome poor long-term adherence with continuous energy restriction (CER), for weight reduction. We compared the effects of IER with CER for fasting and postprandial metabolism and appetite in metabolically healthy participants, in whom excess weight would not confound intrinsic metabolic differences.
Intermittent energy restriction vs. continuous energy restriction on cardiometabolic risk factors in patients with metabolic syndrome: a meta-analysis and systematic review. [2023]This is a systematic review and meta-analysis to compare the efficacy of intermittent energy restriction (IER) vs. continuous energy restriction (CER) on weight loss, body composition, blood pressure, and other cardiometabolic risk factors in patients with metabolic syndrome (MetS) risk factors.
Potential Benefits and Harms of Intermittent Energy Restriction and Intermittent Fasting Amongst Obese, Overweight and Normal Weight Subjects-A Narrative Review of Human and Animal Evidence. [2022]Intermittent energy restriction (IER) has become popular as a means of weight control amongst people who are overweight and obese, and is also undertaken by normal weight people hoping spells of marked energy restriction will optimise their health. This review summarises randomised comparisons of intermittent and isoenergetic continuous energy restriction for weight loss to manage overweight and obesity. It also summarises the potential beneficial or adverse effects of IER on body composition, adipose stores and metabolic effects from human studies, including studies amongst normal weight subjects and relevant animal experimentation. Six small short term (
Effects of Intermittent Energy Restriction Combined with a Mediterranean Diet on Reducing Visceral Adiposity: A Randomized Active Comparator Pilot Study. [2023]Intermittent energy restriction combined with a Mediterranean diet (IER+MED) has shown promise to reduce body fat and insulin resistance. In the Multiethnic Cohort Adiposity Phenotype Study, Japanese Americans had the highest visceral adipose tissue (VAT) when adjusting for total adiposity. We conducted this pilot study to demonstrate feasibility and explore efficacy of following IER+MED for 12 weeks to reduce VAT among East Asians in Hawaii. Sixty volunteers (aged 35-55, BMI 25-40 kg/m2, VAT ≥ 90 cm2 for men and ≥ 80 cm2 for women) were randomized to IER+MED (two consecutive days with 70% energy restriction and 5 days euenergetic MED) or an active comparator (euenergetic Dietary Approaches to Stop Hypertension (DASH) diet). Participants and clinic staff (except dietitians) were blinded to group assignments. IER+MED had significantly larger reductions in DXA-measured VAT and total fat mass (-22.6 ± 3.6 cm2 and -3.3 ± 0.4 kg, respectively) vs. DASH (-10.7 ± 3.5 cm2 and -1.6 ± 0.4 kg) (p = 0.02 and p = 0.005). However, after adjusting for total fat mass, change in VAT was not statistically different between groups; whereas, improvement in alanine transaminase remained significantly greater for IER+MED vs. DASH (-16.2 ± 3.8 U/L vs. -4.0 ± 3.6 U/L, respectively, p = 0.02). Attrition rate was 10%, and participants adhered well to study prescriptions with no reported major adverse effect. Results demonstrate IER+MED is acceptable, lowers visceral and total adiposity among East Asian Americans, and may improve liver function more effectively than a healthful diet pattern. ClinicalTrials.gov Identifier: NCT03639350.
Intermittent versus continuous energy restriction on weight loss and cardiometabolic outcomes: a systematic review and meta-analysis of randomized controlled trials. [2020]This systematic review and meta-analysis summarized the most recent evidence on the efficacy of intermittent energy restriction (IER) versus continuous energy restriction on weight-loss, body composition, blood pressure and other cardiometabolic risk factors.
Intermittent energy restriction and weight loss: a systematic review. [2022]Intermittent energy restriction (IER) is an eating pattern of regular daily periods of restricted energy intake followed by periods of unrestricted energy intake. This is gaining prominence as an alternative weight-loss strategy to daily energy restriction (DER). The aim of this systematic review was to determine the effectiveness of IER on weight loss in overweight and obese adults and compare this with DER.
The Role of Intermittent Energy Restriction Diet on Metabolic Profile and Weight Loss among Obese Adults. [2022]Obesity is a disease defined by an elevated body mass index (BMI), which is the result of excessive or abnormal accumulation of fat. Dietary intervention is fundamental and essential as the first-line treatment for obese patients, and the main rule of every dietary modification is calorie restriction and consequent weight loss. Intermittent energy restriction (IER) is a special type of diet consisting of intermittent pauses in eating. There are many variations of IER diets such as alternate-day fasting (ADF) and time-restricted feeding (TRF). In the literature, the IER diet is known as an effective method for bodyweight reduction. Furthermore, IER diets have a beneficial effect on systolic or diastolic pressure, lipid profile, and glucose homeostasis. In addition, IER diets are presented as being as efficient as a continuous energy restriction diet (CER) in losing weight and improving metabolic parameters. Thus, the IER diet could present an alternative option for those who cannot accept a constant food regimen.
Effect of intermittent compared to continuous energy restriction on weight loss and weight maintenance after 12 months in healthy overweight or obese adults. [2021]Intermittent energy restriction (IER) is an alternative to continuous energy restriction (CER) for weight loss. There are few long-term trials comparing efficacy of these methods. The objective was to compare the effects of CER to two forms of IER; a week-on-week-off energy restriction and a 5:2 program, during which participants restricted their energy intake severely for 2 days and ate as usual for 5 days, on weight loss, body composition, blood lipids, and glucose.