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

Trial Summary

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.

What data supports the effectiveness of the treatment involving Acute Fasting, Acute Overfeeding, and Eucaloric Feeding for obesity in women?

Research shows that fasting can lead to long-term weight loss in some patients, with 48% maintaining or continuing to lose weight after fasting. Additionally, a high-protein diet, which is a form of eucaloric feeding, improved body composition in women, suggesting potential benefits for managing obesity. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Very low calorie diets (VLCDs) have been studied for safety in obese women, showing they can be safe when monitored, but they require careful adherence to ensure nutrient needs are met. ^{5 6 7 8 9}

How does the treatment 'Feeding Conditions for Obesity in Women' differ from other treatments for obesity?

This treatment is unique because it explores different feeding conditions like acute fasting, acute overfeeding, and eucaloric feeding (maintaining calorie intake to match energy expenditure) to understand their effects on obesity in women, rather than relying on medication or surgery. It focuses on how varying eating patterns can influence weight and metabolism, which is different from standard treatments that often involve drugs or lifestyle changes without such specific feeding condition variations. ^{5 10 11 12 13}

What is the purpose of this trial?

This study plans to learn more about why menopause increases the risk of weight gain. During and after menopause, women are prone to increased weight gain. The weight gained is primarily body fat, particularly visceral or abdominal body fat. The excess gain in abdominal fat during menopause increases the risk of chronic metabolic diseases such as heart disease and diabetes. The increase in weight and body fat with menopause may be due to changes in metabolism related to the loss of estrogen. This study plans to compare how the metabolism of premenopausal and postmenopausal women responds to changes in energy intake. The investigators will compare the changes in energy expenditure that occur during a period of acute fasting (24 hours) and a period of consuming excess calories (overfeeding).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Long-term results of fasting. Results from 132 consecutive patients after 1-6 1/2 years]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

The management of short-term intestinal failure in obese patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

The effect of 12 weeks of euenergetic high-protein diet in regulating appetite and body composition of women with normal-weight obesity: a randomised controlled trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Nourishing the obese patient. [2005]

5. England pubmed.ncbi.nlm.nih.gov

Energy intake adaptation of food intake to extreme energy densities of food by obese and non-obese women. [2004]

6. England pubmed.ncbi.nlm.nih.gov

Is ad libitum energy intake in overweight subjects reproducible in laboratory studies using the preload paradigm? [2015]

7. Spain pubmed.ncbi.nlm.nih.gov

[Effectiveness and safety of Very Low Calory Diets in obese patients]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Nutrient adequacy during weight loss interventions: a randomized study in women comparing the dietary intake in a meal replacement group with a traditional food group. [2022]

9. England pubmed.ncbi.nlm.nih.gov

The effect of a very low calorie diet on insulin sensitivity, beta cell function, insulin clearance, incretin hormone secretion, androgen levels and body composition in obese young women. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Does the weight loss efficacy of alternate day fasting differ according to sex and menopausal status? [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Six Weeks of Morning Fasting Causes Little Adaptation of Metabolic or Appetite Responses to Feeding in Adults with Obesity. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Appetite sensations and eating behaviors to complete fasting in obese and non-obese individuals. [2004]

13. England pubmed.ncbi.nlm.nih.gov

The role of macronutrient selection in determining patterns of food intake in obese and non-obese women. [2014]