Feeding Conditions for Obesity in Women

Overseen By Edward L Melanson, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Estrogen-based hormones, Hormonal contraceptives

Disqualifiers: Diabetes, Thyroid dysfunction, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why menopause causes weight gain, particularly around the belly, which can lead to heart disease and diabetes. Researchers will examine how the metabolism of women before and after menopause responds to fasting (acute fasting) and eating more than usual (acute overfeeding). The trial seeks premenopausal women with regular periods and postmenopausal women who haven't had a period for at least 12 months. As an unphased trial, participants can contribute to groundbreaking research that may improve health outcomes for women experiencing menopause.

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 on hormonal contraceptives or estrogen-based hormonal therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that fasting is safe for most people. Research suggests that intermittent fasting does not increase the risk of negative side effects for those who are overweight or obese. Additionally, studies where participants followed fasting routines reported no serious side effects.

Studies have shown that eating more than usual can lead to weight gain, but no major safety concerns have been reported. Consuming more calories than usual may result in temporary weight gain, but it does not appear to cause harmful health effects in the short term.

Eucaloric feeding, which involves eating the same amount of calories as burned, has also been studied. This type of eating is generally considered safe, maintaining a balance between calorie intake and energy use, which helps stabilize weight.

Overall, these treatments have been well-tolerated in most studies, with no significant safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Feeding Conditions for Obesity trial because it explores unique dietary interventions like acute fasting, acute overfeeding, and eucaloric feeding to manage obesity in women. Unlike traditional treatments that often rely on medication or surgery, this approach focuses on manipulating eating patterns and caloric intake, which could offer a non-invasive alternative. This trial aims to understand how different feeding conditions affect weight and metabolism in premenopausal and postmenopausal women, potentially leading to personalized dietary strategies for obesity management.

What evidence suggests that this trial's treatments could be effective for obesity in women?

This trial will compare different feeding conditions in women, including acute fasting, acute overfeeding, and eucaloric feeding. Research has shown that intermittent fasting can aid in weight loss and reduce some heart-related health risks. However, some studies suggest it might not result in more weight loss than other diets. Studies on overeating have found that while it can cause short-term weight gain, most of this weight is usually lost after stopping the extra calorie intake. Eating a balanced diet, where calorie intake matches calorie expenditure, has been linked to changes in body fat, particularly in reducing harmful fat in conditions like PCOS, a disorder affecting women's hormone levels. Each diet affects metabolism differently, and their effects can vary from person to person. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for premenopausal women aged 18-45 with regular menstrual cycles and postmenopausal women who haven't had a period for at least 12 months, preferably within 2 years of their last period. It aims to understand how menopause affects the risk of weight gain by studying changes in metabolism.

Inclusion Criteria

I am a woman aged 18-45 with regular menstrual cycles.

I am a woman who has not had a period for at least 12 months and my FSH level is ≥50 mIU/ml.

Exclusion Criteria

Thyroid dysfunction (ultrasensitive thyroid stimulating hormone (TSH) <0.5 or >5.0 mU/L)

Uncontrolled hypertension (resting systolic BP >150 mmHg or diastolic BP >90 mmHg)

Body mass index > 30 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-study Assessments

Participants complete pre-study assessments including resting energy expenditure, body composition, and visceral adipose tissue volume measurements

1 day

1 visit (in-person)

Eucaloric Condition

Participants undergo a eucaloric study where energy intake equals energy expenditure

24 hours

1 visit (in-person)

Fasting Condition

Participants undergo a 24-hour fasting study to measure energy expenditure and substrate oxidation

24 hours

1 visit (in-person)

Overfeeding Condition

Participants undergo a 24-hour overfeeding study with a low-protein diet to measure energy expenditure and substrate oxidation

24 hours

1 visit (in-person)

Washout Period

A washout period between study conditions to stabilize energy and macronutrient intake

1-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after the study conditions

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acute Fasting
• Acute Overfeeding
• Eucaloric Feeding

Trial Overview The study investigates how premenopausal and postmenopausal women's metabolisms react to fasting (no food for 24 hours) and overfeeding (eating more calories than needed). Researchers will measure energy expenditure during these periods to see if there are differences due to menopause.

How Is the Trial Designed?

Group I: Premenopausal women Experimental Treatment 3 Interventions

Group II: Postmenopausal women Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

In a study of 44 patients with obesity, a Very Low Calorie Diet (VLCD) resulted in an average weight loss of 7 kg and a weight loss rate of 1.2 kg per week, indicating its effectiveness for weight management.

While 33% of participants reported mild side effects, such as constipation and dizziness, the majority (84%) adhered to the VLCD, suggesting that with proper support, adherence can be maintained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of Very Low Calory Diets in obese patients]. Sáez Belló, M., Segarra Villalba, C., Gras Colomer, E., et al.[2018]

The study involved 8 overweight/obese participants and assessed the reproducibility of their energy intake after consuming a liquid preload, showing that ad libitum energy intake was highly reproducible with an intraclass correlation of 0.97 for control preloads.

Participants consumed more energy after a control preload compared to a whey protein preload, indicating that the type of preload can influence subsequent food intake, but overall energy intake remained consistent across repeated trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is ad libitum energy intake in overweight subjects reproducible in laboratory studies using the preload paradigm? Lara, J., Taylor, MA., Macdonald, IA.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8683964/

Intermittent Fasting and Obesity-Related Health Outcomes Outcomes associated with modified alternate-day fasting included a moderate reduction of body weight, body mass index, and cardiometabolic risk ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35939311/

Effectiveness of Early Time-Restricted Eating for Weight Loss ... In this randomized clinical trial, eTRE was more effective for losing weight and improving diastolic blood pressure and mood than eating over a window of 12 or ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0939475323001862

Effectiveness of intermittent fasting for weight loss in ... Intermittent fasting do not lead to a greater weight loss than controls in the obese. Intermittent Fasting do not lead to a reduction in blood pressure in the ...

4. gi.org gi.org/journals-publications/ebgi/paul_february2022/

Effectiveness of Intermittent Fasting for Weight Loss: It's Not ... Outcome: The primary outcome was weight loss. Secondary outcomes included changes in metabolic parameters including fat mass, lean mass, fasting ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-53702400098-1/fulltext

Intermittent fasting and health outcomes: an umbrella ... However, IF was less effective at reducing systolic blood pressure (SBP) than a CER diet in adults with overweight or obesity (SMD = 0.21; 95% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7877980/

Unravelling the health effects of fasting: a long road from ... The present review will investigate the effects of the main forms of fasting, activating the metabolic switch from glucose to fat and ketones (G-to-K).

7. nutritionj.biomedcentral.com nutritionj.biomedcentral.com/articles/10.1186/s12937-024-00975-9

Adverse events profile associated with intermittent fasting in ... This meta-analysis suggested that IF was not associated with a greater risk of AEs in adult patients affected by overweight or obesity.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2451847618300290

The safety and efficacy of weight loss via intermittent ... There were no adverse events during the study, and rates of hypoglycaemia were unchanged. Body weight was reduced from baseline (P < 0.05) by both ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7617461/

The impact of intermittent energy restriction on women's ... Current limited evidence suggests IER is a safe weight loss intervention for women which does not affect reproductive or bone health, increase ...

10. clinicaltrials.gov clinicaltrials.gov/show/NCT03532672

Early Effect of Fasting on Metabolic, Inflammatory, and ... A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity.